On July 27, 2026 AstraZeneca reported results for H1 and Q2 2026.

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Growth momentum continues. On track to deliver ambition of $80 billion in Total Revenue in 2030

Revenue and EPS summary

H1 2026

% Change

Q2 2026

% Change
​

$m

​ ​ ​

Actual

​ ​ ​

CER1

​

$m

​ ​ ​

Actual

​ ​ ​

CER

– Product Sales

28,896

8

5

14,510

5

4

– Alliance Revenue

1,699

31

29

874

34

33

Product Revenue

30,595

9

6

15,384

6

5

Collaboration Revenue

77

(6)

(9)

–

n/m

n/m

Total Revenue

30,672

9

6

15,384

6

5

Reported EPS ($)

3.60

4

3

1.61

2

(2)

Core2 EPS ($)

5.21

12

11

2.63

21

18

Key performance elements for H1 2026

(Growth numbers at constant exchange rates)

● Total Revenue up 6%, with double-digit growth in Oncology and Rare Disease offsetting headwinds from Farxiga US loss of exclusivity and China volume-based procurement
● Core Operating profit and Core EPS increased 11%
● Interim dividend increased 3 cents to $1.06 per share (79.5 pence, 10.32 SEK)
● 30 approvals in major regions since Q4 2025 results

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

"In the first half we saw strong performance and continued pipeline delivery, including six key positive Phase III programmes and eight first approvals in major markets, including in the US for Baxfendy, our first-in-class medicine for hypertension.

While we are disappointed by the CARDIO-TTRansform outcome, we are on track to deliver our $80bn Total Revenue ambition, which assumes successes and setbacks. We remain confident in the strength of our pipeline and have more than twenty high-value readouts due over the next 18 months.

We continue to invest at pace in our transformative technologies, and in our commercial execution to bring our innovative medicines to patients around the globe and drive growth beyond 2030."

Guidance

AstraZeneca reconfirms Total Revenue and Core EPS guidance3 for FY 2026 at CER, based on the average foreign exchange rates through 2025.

Total Revenue is expected to increase by a mid-to-high single-digit percentage

Core EPS is expected to increase by a low double-digit percentage

Results highlights

Table 1: Milestones achieved since the prior results announcement

Phase III and other registrational data readouts

Medicine

​ ​ ​

Trial

​ ​ ​

Indication

​ ​ ​

Event

Imfinzi

VOLGA

MIBC not candidates for cisplatin

Primary endpoint met

Imfinzi

EMERALD-2

Adjuvant HCC

Primary endpoint not met

Imfinzi

NILE

1L bladder cancer

Primary endpoint met

sone-ve

CLARITY-Gastric01

2L+ Cldn18.2+ gastric/GEJ cancer

Primary endpoint met

Wainua

CARDIO-TTRansform

ATTR-CM

Primary endpoint not met

Ultomiris

TMA-313

HSCT-TMA (adults)

Primary endpoint not met

Ultomiris

ALXN1210-MG-319

gMG (paediatric)

Primary endpoint met

Regulatory approvals

Medicine

​

Trial

​

Indication

​ ​

Region

Calquence

AMPLIFY

1L CLL (fixed duration)

JP

Datroway

TROPION-Breast02

1L TNBC for patients where immunotherapy is not an option

US

Enhertu

DESTINY-Breast05

High-risk HER2+ early breast cancer (post-neoadjuvant)

US

Enhertu

DESTINY-Breast11

Neoadjuvant HER2+ Stage II or III breast cancer

US

Enhertu

DESTINY-PanTumor02 / DESTINY-Lung01 / DESTINY-CRC02

HER2-positive solid tumours

EU

Etcamah (camizestrant)

SERENA-6

ESR1m HR+ HER2- 1L locally advanced or metastatic breast cancer

EU, JP

Imfinzi

POTOMAC

NMIBC

US

Imfinzi

MATTERHORN

Resectable gastric/GEJ cancer

JP

Orphathys

NCT04923932

3L+ MET+ gastric/GEJ cancer

CN

Truqap

CAPItello-281

PTEN-deficient mHSPC

US

Baxfendy

BaxHTN

Hypertension

US

Fasenra

NATRON

Hypereosinophilic syndrome

US, EU, JP, CN

Regulatory submissions or acceptances* in major regions

Medicine

​

Trial

​

Indication

​ ​

Region

Baxfendy

BaxHTN / Bax24 / BaxAsia

Hypertension

JP

tozorakimab

OBERON / TITANIA / MIRANDA / PROSPERO

COPD

EU, CN

Ultomiris

I CAN

IgAN

US, JP

efzimfotase alfa

MULBERRY / CHESTNUT / HICKORY

HPP

JP

* US, EU and China regulatory entries in this table denote filing acceptance

Other pipeline updates

Table 2: Key elements of financial performance: Q2 2026

For the quarter

Reported

Change

Core

Change

ended 30 June

​ ​ ​

$m

​ ​ ​

Act

​ ​ ​

CER

​ ​ ​

$m

​ ​ ​

Act

​ ​ ​

CER

​ ​ ​

Product Revenue

15,384

6

5

15,384

6

5

● See Tables 3, 7, 23, 24 and 25 for further details of Product Revenue, Product Sales and Alliance Revenue
Collaboration Revenue

—

n/m

n/m

—

n/m

n/m

● See Tables 4 and 26 for further details of Collaboration Revenue
Total Revenue

15,384

6

5

15,384

6

5

● See Tables 5 and 6 for Total Revenue by Therapy Area and by region
Gross Margin (%)

84

+1pp

—

84

+1pp

+1pp

+ Variations in Gross Margin can be expected between periods due to various factors, including fluctuations in foreign exchange rates, product seasonality and Collaboration Revenue
– Pricing headwinds, including those driven by loss of exclusivity and VBP in China
R&D expense

4,053

14

13

3,662

6

5

● Core R&D: 24% of Total Revenue
+ Increasing number of trials, and patients in those trials
+ Investments in transformative technologies
+ Addition of R&D projects from business development
+ Positive data readouts for high value pipeline opportunities that have ungated large late-stage trials
SG&A expense

5,651

16

14

4,050

7

4

● Core SG&A: 26% of Total Revenue
+ Investment to support ongoing and future launches
Other operating income and expense4

152

92

93

152

>2x

>2x

+ Various partner milestones
Operating profit

3,164

(10)

(13)

5,158

12

10

Operating Margin (%)

21

-4pp

-4pp

34

+2pp

+2pp

Net finance expense

355

(4)

(8)

340

13

8

+

Lower interest income on short-term deposits

– Reported Net finance expense benefitted from a lower discount unwind on contingent consideration liabilities
Tax rate (%)

10

-11pp

-11pp

15

-6pp

-6pp

– Benefit from adjustments to deferred tax assets, as a result of certain internal legal entity changes.
● Variations in the tax rate can be expected between periods
EPS ($)

1.61

2

(2)

2.63

21

18

For dollar values in this table, the unit of change is percent. For Gross Margin, Operating Margin and Tax rate, the unit of change is percentage points (pp).

In the table above, R&D expense, SG&A expense and Net finance expense are displayed as positive numbers. The plus and minus symbols next to comments denote the directional impact of the item being discussed. For example, a plus symbol next to a comment about an R&D item indicates that the item increased R&D expenditure relative to the prior year period.

Corporate and business development

Dizal Pharmaceutical Co

In July 2026, AstraZeneca entered into an exclusive license agreement with Dizal Pharmaceutical Co (Dizal), Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible EGFR inhibitor for patients with lung cancer.

AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy, which is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances.

Sino Biopharmaceutical

In July 2026, AstraZeneca and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited, entered into an exclusive licence agreement for the development, manufacturing and commercialisation of CTTQ’s PDE3/4 inhibitor, TQC3721, which is being developed for respiratory indications.

Sino Biopharmaceutical Limited is eligible to receive an upfront payment of $200m, with additional development, regulatory and sales milestones up to $1.9bn, as well as tiered royalties ranging up to double-digit percentages based on the annual net sales of TQC3721 products.

The agreement is subject to customary closing conditions, including regulatory clearances.

Sustainability highlights

In July 2026, AstraZeneca hosted a call for investors to discuss the latest developments in its Sustainability strategy. A replay of the call is available on astrazeneca.com.

Reporting calendar

The Company intends to publish its 9M and Q3 2026 results on 30 October 2026.

Conference call

A conference call and webcast for investors and analysts will begin today, 27 July 2026, at 11:45 UK time. Details can be accessed via astrazeneca.com.

Notes

1.

Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2026 vs. 2025. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.

2.

Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Tables 10 and 11 in the Financial Performance section of this document.

3.

The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the Cautionary statements section regarding forward-looking statements at the end of this announcement.

4.

Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, is recorded in Other operating income and expense in the Group’s financial statements.

Revenue drivers

Table 3: Product Revenue (PR) by medicine

​ ​ ​

H1 2026

​ ​ ​

​ ​ ​

% Change

​ ​ ​

Q2 2026

​ ​ ​

​ ​ ​

​ ​ ​

% Change

$m

% Total

Actual

CER

$m

% Total

Actual

CER

Tagrisso

3,775

12

8

6

1,941

13

7

6

Imfinzi

3,548

12

31

29

1,854

12

27

27

Calquence

1,944

6

19

16

1,022

7

17

16

Lynparza

1,610

5

3

(1)

829

5

(1)

(3)

Enhertu

1,719

6

36

32

888

6

33

31

Zoladex

631

2

7

3

316

2

7

3

Truqap

431

1

43

41

233

2

37

37

Imjudo

160

1

(6)

(7)

83

1

(7)

(7)

Datroway

98

–

>6x

>6x

55

–

>5x

>5x

Etcamah

3

–

n/m

n/m

3

–

n/m

n/m

Other Oncology

204

1

(6)

(8)

102

1

(4)

(5)

Oncology PR

14,123

46

18

15

7,326

48

16

15

Farxiga

3,998

13

(5)

(11)

1,804

12

(16)

(19)

Crestor

686

2

8

4

332

2

4

1

Lokelma

419

1

28

26

221

1

26

26

Seloken

337

1

9

5

157

1

6

2

Brilinta

186

1

(64)

(66)

80

1

(62)

(63)

Wainua

121

–

44

44

70

–

58

58

roxadustat

57

–

(63)

(64)

14

–

(81)

(82)

Baxfendy

3

–

n/m

n/m

3

–

n/m

n/m

Other CVRM

206

1

(25)

(28)

91

1

(34)

(35)

Cardiovascular, Renal & Metabolism PR

6,013

20

(8)

(12)

2,772

18

(15)

(18)

Symbicort

1,418

5

(1)

(4)

671

4

(6)

(8)

Fasenra

1,053

3

14

12

570

4

14

13

Breztri

699

2

20

17

346

2

22

20

Tezspire

694

2

43

40

390

3

46

45

Saphnelo

380

1

25

24

209

1

25

24

Pulmicort

269

1

2

(3)

120

1

13

9

Airsupra

87

–

24

23

50

–

19

18

Other R&I

150

–

(13)

(15)

75

–

11

8

Respiratory & Immunology PR

4,750

16

12

9

2,431

16

13

11

Beyfortus

194

1

(18)

(18)

79

1

(37)

(37)

FluMist

26

–

>2x

>2x

18

–

79

78

Other ID

92

–

(43)

(47)

34

–

(31)

(34)

Infectious Disease PR

312

1

(24)

(26)

131

1

(29)

(30)

Ultomiris

2,584

8

16

14

1,314

9

12

12

Soliris

778

3

(20)

(22)

389

3

(27)

(28)

Strensiq

1,053

3

41

40

536

3

36

36

Koselugo

347

1

26

21

177

1

29

27

Other Rare Disease

149

–

32

25

74

–

36

33

Rare Disease PR

4,911

16

13

11

2,490

16

9

8

Other Medicines PR

486

2

(6)

(8)

234

2

(4)

(6)

Product Revenue

30,595

100

9

6

15,384

100

6

5

Alliance Revenue included above:

​

Enhertu

1,058

3

27

24

550

4

26

24

Tezspire

372

1

31

31

218

1

41

41

Beyfortus

123

–

12

12

32

–

14

14

Datroway

93

–

>6x

>6x

51

–

>4x

>4x

Other royalty revenue

51

–

10

10

22

–

(4)

(4)

Other Alliance Revenue

2

–

(22)

(22)

1

–

(42)

(42)

Alliance Revenue

1,699

6

31

29

874

6

34

33

Table 4: Collaboration Revenue

H1 2026

% Change

Q2 2026

% Change

​ ​ ​

$m

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

Actual

​ ​ ​

CER

Farxiga: sales milestones

44

(43)

(45)

–

n/m

n/m

Crestor: sales milestones

32

n/m

n/m

–

n/m

n/m

Others

1

n/m

n/m

–

n/m

n/m

Collaboration Revenue

77

(6)

(9)

–

n/m

n/m

Table 5: Total Revenue by Therapy Area

H1 2026

% Change

Q2 2026

% Change

​ ​ ​

$m

​ ​ ​

% Total

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

% Total

​ ​ ​

Actual

​ ​ ​

CER

Oncology

14,124

46

18

15

7,327

48

16

15

– Cardiovascular, Renal & Metabolism

6,089

20

(8)

(12)

2,772

18

(15)

(18)

– Respiratory & Immunology

4,750

15

12

9

2,431

16

13

11

– Infectious Disease

312

1

(24)

(26)

131

1

(29)

(30)

BioPharmaceuticals

11,151

36

(1)

(5)

5,334

35

(5)

(7)

Rare Disease

4,911

16

13

11

2,490

16

9

8

Other Medicines

486

2

(7)

(9)

233

2

(7)

(8)

Total Revenue

30,672

100

9

6

15,384

100

6

5

Table 6: Total Revenue by region

H1 2026

​ ​ ​

% Change

Q2 2026

% Change

​ ​ ​

$m

% Total

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

% Total

​ ​ ​

Actual

​ ​ ​

CER

US

12,890

42

8

8

6,686

43

6

6

– Emerging Markets ex. China

4,809

16

15

10

2,334

15

14

11

– China

3,510

11

–

(5)

1,587

10

(7)

(13)

Emerging Markets

8,319

27

8

3

3,921

25

4

–

Europe

6,822

22

17

8

3,417

22

11

7

Established RoW

2,641

9

3

5

1,361

9

4

8

Total Revenue

30,672

100

9

6

15,384

100

6

5

Table 7: Product Revenue by region

​ ​ ​

H1 2026

% Change

Q2 2026

% Change

$m

​ ​ ​

% Total

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

% Total

​ ​ ​

Actual

​ ​ ​

CER

US

12,889

42

8

8

​

​

6,685

43

6

6

– Emerging Markets ex. China

4,809

16

15

10

2,334

15

14

11

– China

3,510

11

–

(5)

1,587

10

(7)

(13)

Emerging Markets

8,319

27

8

3

3,921

25

4

–

Europe

6,822

22

17

8

3,417

22

11

7

Established RoW

2,565

8

4

6

1,361

9

4

9

Total Product Revenue

30,595

100

9

6

15,384

100

6

5

Total Revenue by Medicine

Oncology

Tagrisso

H1 2026

Total

% Change

● Strong demand growth across indications and key regions, positioned as backbone
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

across all stages of EGFRm NSCLC. Leading combination in 1L NSCLC (FLAURA2)

US

1,579

10

10

● Robust underlying demand
Emerging Markets

1,048

4

–

● More competitive environment in China in a slowing EGFRm TKI market
Europe

769

17

8

Established RoW

379

(1)

2

● Recent competitor entrant
Total

3,775

8

6

Imfinzi

H1 2026

Total

% Change

● Strong demand growth across all regions from existing indications and new
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

launches

US

2,008

28

28

● Demand growth led by new GI and GU launches (MATTERHORN, NIAGARA)
Emerging Markets

398

35

32

● Strong growth in GI (HIMALAYA, TOPAZ) including new launches (MATTERHORN)
Europe

781

45

34

● Early momentum for new lung (ADRIATIC), GI (MATTERHORN) and GU (NIAGARA) launches
Established RoW

361

15

20

● Demand growth from new launches across GYN (DUO-E), GU (NIAGARA) and lung (ADRIATIC, AEGEAN)
Total

3,548

31

29

Calquence

H1 2026

Total

% Change

● Sustained BTKi leadership in front-line CLL with launch momentum across
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

finite use for 1L CLL (AMPLIFY) and 1L MCL (ECHO)

US

1,286

18

18

● Strong demand growth from ongoing leadership in front-line CLL BTKi market
Emerging Markets

137

33

26

Europe

442

20

11

● Further expansion in finite use for 1L CLL and 1L MCL
Established RoW

79

9

7

Total

1,944

19

16

Lynparza

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

● Global leadership in mature first-generation PARPi market
US

659

(4)

(4)

● Demand growth offset by channel mix and inventory destocking
Emerging Markets

343

6

(1)

● Affected by generic competition in China and VBP implementation
Europe

480

13

4

● Continued uptake in prostate (PROpel) and breast (OlympiA) indications
Established RoW

128

1

3

Total

1,610

3

(1)

Enhertu

Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca, amounted to $2,961m in H1 2026 (H1 2025: $2,289m). US in-market sales, recorded by Daiichi Sankyo, amounted to $1,440m in H1 2026 (H1 2025: $1,128m). For periods up to and including Q3 2025, AstraZeneca’s mid-single-digit percentage royalty on Daiichi Sankyo’s sales in Japan is recorded in Europe; from Q4 2025 this royalty is recorded in Established RoW.

H1 2026

Total

% Change

● Standard-of-care in HER2-positive (DESTINY-Breast03) and HER2-low
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

(DESTINY-Breast04) metastatic breast cancer, early uptake in other cancers

US

694

28

28

● Ongoing adoption in 1L HER2-positive breast cancer (DESTINY-Breast09)
Emerging Markets

528

45

41

● Continued adoption post-NRDL enlistment of HER2-positive and HER2-low breast cancer from 1 January 2025
Europe

401

28

18

● Further demand growth in chemotherapy naïve HER2-low breast cancer
Established RoW

96

>2x

>2x

Total

1,719

36

32

Other Oncology medicines

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

Zoladex

632

8

3

● Growth across Emerging Markets
Truqap

431

43

41

● Achieved peak share in second-line biomarker-altered metastatic breast cancer
Imjudo

160

(6)

(7)

● Continued GI (HIMALAYA) growth ex-US, offset by US destocking and lower demand in some markets
Datroway

98

>7x

>6x

● Continued uptake in breast cancer and EGFRm later-line lung cancer
● Combined global sales by AstraZeneca and Daiichi Sankyo: $225m (H1 2025: $45m)
Etcamah

3

n/m

n/m

● Sales from first launch markets
Other Oncology

204

(6)

(8)

● Generic erosion across markets

Other Oncology includes $14m of Total Revenue from Orpathys, partnered with HUTCHMED.

BioPharmaceuticals – Cardiovascular, Renal & Metabolism

Farxiga

H1 2026

Total

% Change

● Growth impacted by US LoE and China VBP
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

US

668

(17)

(17)

● Multiple generics launched in Q2 2026
Emerging Markets

1,618

(6)

(13)

● Affected by generic competition and VBP implementation in China in Q1 2026
Europe

1,586

10

1

● Demand growth offset by generic entry in the UK in Q3 2025
Established RoW

169

(44)

(45)

● Generic T2D entry in Japan in Q4 2025. Milestone receipt in Q1 2026
Total

4,042

(6)

(11)

Other CVRM medicines

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

Crestor

719

13

9

● Growth driven by Emerging Markets and Est. RoW. Milestone receipt in Q1 2026
Lokelma

419

28

26

● Strong growth in all major regions
Seloken

337

9

5

● Growth driven by Emerging Markets
Brilinta

186

(64)

(66)

● Decline driven by generic entry in the US and Europe in Q2 2025
Wainua

121

44

44

● Demand growth in ATTR-PN and geographic expansion
roxadustat

57

(63)

(64)

● Affected by generic competition in China and VBP implementation in Q1 2026
Baxfendy

3

n/m

n/m

● US launch in hypertension in Q2 2026
Other CVRM

206

(25)

(28)

● Generic erosionBioPharmaceuticals – Respiratory & Immunology

Symbicort

H1 2026

Total

% Change

● Market leader in ICS/LABA class with increasing generic competition
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

US

545

(9)

(9)

● New generic competitor entered the market
Emerging Markets

417

4

–

Europe

296

9

1

Established RoW

160

(5)

(8)

Total

1,418

(1)

(4)

Fasenra

H1 2026

Total

% Change

● Expanded severe eosinophilic asthma market share leadership in IL-5 class,
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

further fuelled by accelerated EGPA indication launches

US

594

7

7

● Strong demand with expanded IL-5 class leadership partially offset by Q1 inventory movement and gross-to-net adjustments
Emerging Markets

92

75

69

● Strong China uptake post Q1 2026 NRDL listing with growth in other key markets
Europe

258

13

4

● Increased leadership in severe eosinophilic asthma partially offset by pricing
Established RoW

109

31

33

● Strong growth supported by EGPA in Japan
Total

1,053

14

12

Breztri

H1 2026

Total

% Change

● Fastest growing medicine within the expanding FDC triple class (ICS/LABA/LAMA)
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

US

309

5

5

● Consistent share growth offset by unfavourable gross-to-net adjustments.
● Approval for asthma in April 2026
Emerging Markets

208

34

27

● Market share leadership within FDC triple class in China
Europe

127

45

34

● Sustained growth from market share gains
Established RoW

55

24

24

Total

699

20

17

Tezspire

Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $1,150m in H1 2026 (H1 2025: $826m).

​ ​ ​

H1 2026

Total

% Change

● Sustained demand growth in severe asthma with launch momentum across
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

multiple markets

US

372

31

31

● Continued strong demand growth in severe asthma and launch of CRSwNP
Emerging Markets

44

>2x

>2x

● Strong continued uptake
Europe

202

57

46

● Continued new-to-brand leadership across multiple markets and market growth
Established RoW

75

39

43

Total

694

43

40

Other R&I medicines

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

Saphnelo

380

25

24

● Strong US demand growth, ongoing launches in Europe and Established RoW
Pulmicort

269

2

(3)

● Continued pressure in China, Europe, and Established RoW
Airsupra

87

24

23

● US demand volume growth
Other R&I

150

(13)

(15)

BioPharmaceuticals – Infectious Disease

Beyfortus Total Revenue reflects the sum of Product Sales from AstraZeneca’s sales of manufactured product to Sanofi, and Alliance Revenue from AstraZeneca’s share of gross profits and royalties on sales in major markets outside the US.

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

Beyfortus

194

(18)

(18)

● Partner’s adjustment of inventory levels
FluMist

26

>2x

>2x

Other ID

92

(43)

(47)

● Other includes Synagis, which declined due to competition from Beyfortus

Rare Disease

Ultomiris

Ultomiris Total Revenue includes sales of Voydeya, which is approved as an add-on treatment to Ultomiris and Soliris for the ~20-30% of PNH patients who experience clinically significant EVH.

H1 2026

Total

% Change

● Growth due to patient demand, both naïve to C5 medicines and conversion from
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

Soliris across all indications (gMG, NMOSD, aHUS and PNH)

US

1,398

10

10

● Demand growth across indications, including within the competitive gMG and PNH landscapes
Emerging Markets

190

68

65

● Expansion into new markets and growth in patient demand
Europe

605

22

12

● Demand growth following launches; competition in gMG and PNH
Established RoW

391

13

17

● Continued conversion and strong patient demand
Total

2,584

16

14

Soliris

H1 2026

Total

% Change

● Decline driven by conversion of patients to Ultomiris across all indications,
$m

​

Revenue

​ ​

Actual

​ ​

CER

​ ​

competition in gMG and PNH

US

414

(27)

(27)

● Affected by biosimilar pressure
Emerging Markets

248

10

6

● Growth from launches
Europe

61

(46)

(50)

● Affected by biosimilar pressure in PNH and aHUS
Established RoW

55

(20)

(21)

Total

778

(20)

(22)

Strensiq

H1 2026

Total

% Change

● Growth driven by continued HPP patient demand
$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

US

859

47

47

Emerging Markets

65

30

13

Europe

68

20

10

● Demand growth following new launches
Established RoW

61

10

14

Total

1,053

41

40

Other Rare Disease medicines

​ ​

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​

Koselugo

347

26

21

● Continued patient demand and geographic expansion. Strong uptake following launch of adult indication. US growth offset by competitive pressures
Other Rare Disease

149

32

25

● Other Rare Disease medicines include Kanuma and Beyonttra (JP only)

Other Medicines

H1 2026

Total

% Change

$m

​ ​ ​

Revenue

​ ​ ​

Actual

​ ​ ​

CER

​ ​ ​

Other Medicines

486

(7)

(9)

● Generic erosionR&D progress

This section covers R&D events and milestones that occurred from 29 April 2026 up to and including 26 July 2026. A comprehensive view of AstraZeneca’s pipeline of medicines in human trials can be found in the latest Clinical Trials Appendix, available on AstraZeneca’s investor relations webpage. The Clinical Trials Appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.

Oncology

AstraZeneca presented new data across its diverse portfolio of cancer medicines at one major medical congress since the prior results announcement: the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026 (ASCO) (Free ASCO Whitepaper). At this meeting, more than 85 abstracts were presented featuring 23 approved and potential new medicines including 25 oral presentations.

Calquence

Approval

JP

AMPLIFY

June 2026

New disclosure

● As time-limited treatment (fixed-duration regimen) in combination with venetoclax for the treatment of adult patients with chronic lymphocytic leukaemia (including small lymphocytic lymphoma).

Datroway

Approval

US

TROPION-Breast02

May 2026

● Unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor therapy.
CHMP opinion

EU

TROPION-Breast02

June 2026

● 1st-line treatment of unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor therapy.

Enhertu

Approval

US

DESTINY-Breast05

May 2026

● As adjuvant treatment for HER2-positive (IHC 3+ or ISH+) breast cancer with residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.
Approval

US

DESTINY-Breast11

May 2026

● As neoadjuvant treatment for HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorised test followed by a taxane, trastuzumab, and pertuzumab.
Approval

EU

DESTINY-PanTumor02 / DESTINY-Lung01 / DESTINY-CRC02

June 2026

● As monotherapy for the treatment of unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.
CHMP opinion

EU

DESTINY-Breast09

July 2026

New disclosure

● In combination with pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

Etcamah (camizestrant)

Approval

EU

SERENA-6

July 2026

● In combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
Approval

JP

SERENA-6

June 2026

New disclosure

● Inoperable or recurrent hormone receptor-positive, HER2-negative breast cancer with ESR1 mutation confirmed during endocrine therapy and no disease progression has been observed.

Imfinzi

Phase III readout

VOLGA

May 2026

● Perioperative treatment with Imfinzi in combination with neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in EFS and OS in patients with MIBC versus standard of care.
Phase III data presentation

EMERALD-3

June 2026

● Positive results from the EMERALD-3 Phase III trial demonstrated the STRIDE regimen combined with lenvatinib and TACE demonstrated a 30% reduction in the risk of disease progression or death versus TACE alone (PFS HR 0.70; 95% CI 0.57-0.86; p=0.0007). The median PFS was 13.0 months for this regimen versus 9.8 months for TACE. For the secondary endpoint of OS, a positive trend was observed in favour of the STRIDE regimen with lenvatinib and TACE versus TACE alone (HR 0.84; 95% CI 0.65-1.09; p=0.1814).
Approval

US

POTOMAC

May 2026

● In combination with Bacillus Calmette-Guérin is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer.
Approval

JP

MATTERHORN

June 2026

New disclosure

● In combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastroesophageal junction adenocarcinoma.
Regulatory update

EU

POTOMAC

July 2026

New disclosure

● Voluntary withdrawal of the Type II variation application for Imfinzi in combination with Bacillus Calmette-Guérin for the treatment of BCG-naïve, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial.
Phase III readout

EMERALD-2

Q2 2026

New disclosure

● The EMERALD-2 Phase III trial of Imfinzi in combination with bevacizumab as adjuvant therapy after curative resection or ablation in HCC patients at high risk of recurrence did not meet the primary endpoint of recurrence-free survival versus placebo. The safety and tolerability profiles for Imfinzi monotherapy and in combination with bevacizumab were consistent with the established profiles of each product.
Phase III readout

NILE

Q2 2026

New disclosure

● Positive high-level results from the NILE Phase III trial showed that one dual primary endpoint was met, with Imfinzi plus chemotherapy demonstrating a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer. Imfinzi plus Imjudo with chemotherapy did not meet the other dual primary endpoint of OS versus chemotherapy in the same PD-L1 high population. The safety profiles for Imfinzi and Imjudo were consistent with their known profiles.
Phase III update

PACIFIC-8

Q2 2026

New disclosure

● Recruitment into the PACIFIC-8 Phase III trial of Imfinzi in combination with domvanalimab versus Imfinzi alone in patients with PD-L1 positive Stage III unresectable NSCLC has been discontinued based on results of the Arcus/Gilead Phase III trials STAR-121 and STAR-221 containing domvanalimab. There were no new safety signals in PACIFIC-8.

Lynparza

Regulatory update

CN

PROfound

June 2026

New disclosure

● Label revision to remove PROfound indication (BRCAm mCRPC) based on conditional approval lapse; Post Marketing Commitment not fulfilled.

Orpathys

Approval

CN

NCT04923932

July 2026

● Locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments.

sonesitatug vedotin (sone-ve)

Phase III readout

CLARITY-Gastric01

July 2026

New disclosure

● The CLARITY-Gastric01 global Phase III trial for sonesitatug vedotin had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population.
● The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement.
● For the second dual primary endpoint of PFS as assessed by blinded independent central review, results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance.

Truqap

Approval

US

CAPItello-281

June 2026

● In combination with abiraterone and prednisone for PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer.

BioPharmaceuticals – Cardiovascular, Renal & Metabolism

Baxfendy

Approval

US

BaxHTN

May 2026

● For the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

elecoglipron

Data presentation

ADA

VISTA/SOLSTICE

June 2026

● In the VISTA Phase IIb trial in adults with obesity or overweight and at least one comorbidity, elecoglipron demonstrated a clinically meaningful and statistically significant average reduction in body weight of 10.5% at 26 weeks compared to 0.6% with placebo, a dual primary endpoint. Weight loss in participants receiving elecoglipron did not plateau, reaching 11.8% at 36 weeks (75mg) versus 0.3% with placebo. In the SOLSTICE Phase IIb trial in patients with type 2 diabetes, elecoglipron demonstrated a clinically meaningful and statistically significant average reduction in HbA1c of 1.9% from baseline at 26 weeks compared to 0.2% with placebo, the trial’s primary endpoint.

Wainua

Phase III readout

CARDIO-TTRansform

July 2026

● Wainua in patients with ATTR-CM did not meet the primary efficacy endpoint of the composite outcome of CV mortality and recurrent CV clinical events up to 140 weeks compared with placebo. In a prespecified subgroup analysis of patients treated with Wainua monotherapy as compared to placebo, fewer primary composite events (CV mortality and recurrent CV events) were observed and this result was nominally significant. In patients who were on stabiliser therapy at baseline, no treatment effect was observed.

BioPharmaceuticals – Respiratory & Immunology

Breztri

CHMP opinion

EU

KALOS/LOGOS

July 2026

● Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and long-acting beta2-agonist.

Fasenra

Approval

US

NATRON

May 2026

New disclosure

● For the treatment of adult and paediatric patients aged 12 years and older with HES without an identifiable non-hematologic secondary cause.
Approval

JP

NATRON

May 2026

New disclosure

● For the treatment of HES in adult and paediatric patients aged 12 years and older.
Approval

CN

NATRON

May 2026

New disclosure

● For the treatment of HES in adults and adolescents aged 12 years and older without a definite non-hematologic secondary cause.
Approval

EU

NATRON

July 2026

New disclosure

● Add on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled HES without an identifiable non-haematologic secondary cause.

Rare Disease

anselamimab

Data presentation

ASCO

CARES

June 2026

● The global CARES Phase III clinical programme, in a prespecified subgroup analysis of patients with kappa predominant light chain isotype, anselamimab improved survival by 62%, measured by all-cause mortality (HR 0.38; 95% CI 0.17-0.86; nominal p=0.012), and reduced the frequency of cardiovascular hospitalisations by 71% (incidence risk ratio 0.29; 95% CI 0.10-0.87; nominal p=0.028), compared to placebo.
eneboparatide

Data presentation

ECE

CALYPSO

May 2026

● The CALYPSO Phase III trial showed that 31.1% of patients treated with eneboparatide met the composite primary endpoint, achieving sCa within normal range (8.3-10.6 mg/dL) and independence from oral supplements at week 24, compared with 5.9% of patients in the placebo group (eneboparatide: n=41/132; placebo: n=4/68; p=0.0001) in patients with chronic hypoparathyroidism.

efzimfotase alfa

Data presentation

ICCBH

MULBERRY

June 2026

● Positive results from the MULBERRY Phase III trial showed that efzimfotase alfa achieved an observed median RGI-C Score of 1.67 at week 25 compared to an observed median score of 0 in the placebo group, with a median difference of 1.67 (95% CI: 0.66, 2.00; p=0.0003) in children (2 to <12 years of age) with HPP.
Data presentation

ICCBH

CHESTNUT

June 2026

● In the CHESTNUT trial, efzimfotase alfa demonstrated a similar incidence of treatment-emergent adverse events at week 25 in children (2 to <12 years of age) with HPP who switched from Strensiq (90.5%) compared to those who remained on Strensiq (86.4%) with a favourable safety profile.

Ultomiris

Data presentation

ERA

I CAN

June 2026

● Positive results from a prespecified interim analysis of the I CAN Phase III, Ultomiris demonstrated a 46.6% reduction in 24-hour UPCR from baseline (95% CI: 39.0%, 53.2%) at week 34, compared to 5.6% (95% CI: -4.9%, 15.0%) in patients with IgAN receiving placebo, resulting in a placebo-adjusted treatment effect of 43.4% (95% CI: 33.5%, 51.8%; p<0.0001) in patients.
Phase III trial update

ALXN1210-TMA-313
July 2026

New disclosure

● High-level results showed that Ultomiris did not achieve statistical significance for the primary endpoint of event-free survival through 26 weeks compared to placebo in adults and adolescents (aged 12 years or older) with thrombotic microangiopathy after haematopoietic stem cell transplant. The primary endpoint was defined as the time from randomisation until TMA-related clinical worsening or death, whichever occurred first. Ultomiris showed a trend toward treatment benefit in adults and adolescents , discussions with health authorities are ongoing regarding the interpretation of these data, including in the context of real-world evidence.
● In paediatric patients with HSCT-TMA, the ALXN1210-TMA-314 open-label Phase III trial of Ultomiris, we are advancing regulatory filings, based on data from the open-label Phase III trial we reported in 2025, and data from an external control study.
Phase III readout

ALXN1210-MG-319

July 2026

New disclosure

● High-level results from ALXN1210-MG-319 Phase III, single arm, open label trial evaluating Ultomiris in paediatric and adolescent patients with generalised myasthenia gravis met its primary endpoints and demonstrated efficacy consistent with that seen in the adult population (ALXN1210-MG-306), with safety consistent with the established profile of Ultomiris.

Sustainability

Sustainability highlights

AstraZeneca received several prestigious recognitions for its sustainability leadership in the quarter. TIME Magazine named AstraZeneca one of the World’s Most Sustainable Companies for the third consecutive year, ranking it as the third most sustainable pharmaceutical company, and the Financial Times featured AstraZeneca in its 2026 Europe’s Climate Leaders list for the sixth consecutive year, ranking it as the top pharmaceutical company for climate action. AstraZeneca also ranked in Gartner’s Supply Chain Top 25, which includes ESG criteria, for the fourth consecutive year and as the highest-ranked pharmaceutical company for the second year running.

At the 79th World Health Assembly (WHA) in Geneva, Switzerland, the AstraZeneca delegation led by Chair Michel Demaré and EVP International, Iskra Reic, engaged more than 100 stakeholders, including over 30 government officials, to advance action related to health equity and health systems resilience. The delegation participated in over 10 government and partner-co-hosted events, including a flagship Lung Health event; a panel on implementing the WHO’s 2025 Rare Disease resolution; a roundtable on rare disease in Asia; and a roundtable on Chronic Kidney Diseases.

Climate and nature

The Company achieved milestones related to clean heat:

–

In March, AstraZeneca launched a supplier decarbonisation programme with Secaro and ERM to support clean heat adoption across its supplier network, which was profiled in Forbes.

–

In April, the renewable natural gas (RNG) facility supplying AstraZeneca’s US R&D and manufacturing sites was formally commissioned, with Virginia state leaders in attendance.

–

In June, a partnership to supply renewable liquified natural gas (RLNG) to the Company’s Puerto Rico site was announced.

The Company achieved gold status in the Government of Canada’s Environment and Climate Change Net-Zero Challenge, becoming the first pharmaceutical company in Canada to reach this tier.

In the UK, AstraZeneca was named Green Business of the Year by the British Business Awards and also received the 2026 Society for Chemical Industry (SCI) Sustainability Award for reducing solvent use, in recognition of the Company’s setting a new benchmark in environmental stewardship in pre-clinical chemistry.

Health equity

AstraZeneca advanced its focus on health equity in science through two strategic genomics partnerships which provide access to large-scale datasets representing more than 520,000 participants globally, including from underserved communities.

In the US, the Company delivered its first clinical trial awareness event for underserved areas in Baltimore. AstraZeneca’s global clinical trial website was made available in Portuguese and Vietnamese, in alignment with Company’s Health equity priority countries.

In May 2026, Healthy Heart Africa (HHA) formalised its first Memorandum of Understanding with Morocco’s Ministry of Health, marking a strategic partnership with PATH to expand into Morocco.

Through the Young Health Programme (YHP), AstraZeneca continued to strengthen community impact, expanding work with NGO partners to advance NCD prevention and health equity for young people. This included partnerships in Colombia, Costa Rica, Estonia, Kenya, Malaysia and Spain. The programme received external recognition in Vietnam with a Certificate of Merit by the Ministry of Education & Training.

By July, AstraZeneca’s Cancer Care Africa (CCA) initiative had supported cancer screening for over 328,000 patients and trained over 28,000 oncology healthcare professionals, since 2024. Key CCA achievements during the first half of 2026 include an international multidisciplinary team (MDT) collaboration to reduce variability in Hepatocellular Carcinoma (HCC) care across Ministry of Health (MoH) centres in Egypt and expansion of local diagnostic capacity in Kenya to now include BRCA testing.

Health systems resilience

Following the publication of the Canada roadmap in March, the Partnership for Health System Sustainability and Resilience (PHSSR) launched new country policy roadmaps on acting early on NCDs for France, Germany, Greece, Italy, and Japan. AstraZeneca supported through input on evidence-based, country-specific policy recommendations and activation of key stakeholders during launch.

In Germany, the PHSSR roadmap on early action for NCDs underscored the importance of ensuring broad access to innovative medicines in the context of ongoing health reforms, covered in the Tagesspiegel Background.

AstraZeneca announced a Memorandum of Understanding (MOU) with Northern Ireland’s Department of Health, Department for the Economy and the Health Innovation Research Alliance Northern Ireland (HIRANI), to facilitate earlier, community-based intervention to improve patient outcomes and address health inequalities.

How we do business

During Learning at Work Week in May, AstraZeneca highlighted its ‘3Es’ framework Education, Exposure and Experience, which supports colleagues to build skills through formal learning and real-world experience tailored to their roles, learning styles and career aspirations.

For the third year in a row, AstraZeneca was named The Times’ Graduate Employer of Choice in R&D.

Operating and financial review

Reporting currency

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise.

Reporting period

The performance shown in this announcement covers the six-month period to 30 June 2026 (‘H1 2026’) compared to the six-month period to 30 June 2025 (‘H1 2025’), and the three-month period to 30 June 2026 (‘the quarter’ or ‘Q2 2026’) compared to the three-month period to 30 June 2025 (‘Q2 2025’), unless stated otherwise.

Non-GAAP financial measures

Core financial measures, EBITDA, Net debt, Core Tax rate and CER are non-GAAP financial measures because they cannot be derived directly from the Group’s Condensed consolidated financial statements.

Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to better understand the financial performance and position of the Group on a comparable basis from period to period.

These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.

Core financial measures are adjusted to exclude certain significant items:

–

Charges and provisions related to our global restructuring programmes, which includes charges that relate to the impact of restructuring programmes on our capitalised manufacturing assets and IT assets

–

Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets

–

Other specified items, principally comprising acquisition-related costs and credits, which include the imputed finance charges and fair value movements relating to contingent consideration on business combinations, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, remeasurement adjustments relating to certain Other payables, debt items assumed from the Alexion acquisition and legal settlements

–

The tax effects of the adjustments above are excluded from the Core Tax charge

Details on the nature of Core financial measures are provided on page 53 of the Annual Report and Form 20-F Information 2025.

Reference should be made to the Reconciliation of Reported to Core financial measures table included in the Financial Performance section in this announcement.

Definitions

Gross Margin is defined as Gross Profit as a percentage of Total Revenue.

EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the Financial Performance section in this announcement.

Operating Margin is defined as Operating profit as a percentage of Total Revenue.

Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 ‘Net debt’, included in the Notes to the interim financial statements in this announcement.

The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca’s financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.

Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.Financial performance

Table 8: Reported Profit and Loss

H1 2026

H1 2025

% Change

​

​

Q2 2026

Q2 2025

% Change

​ ​ ​

$m

​ ​ ​

$m

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

$m

​ ​ ​

Actual

​ ​ ​

CER

– Product Sales

28,896

26,670

8

5

14,510

13,795

5

4

– Alliance Revenue

1,699

1,293

31

29

874

654

34

33

Product Revenue

30,595

27,963

9

6

15,384

14,449

6

5

Collaboration Revenue

77

82

(6)

(9)

–

8

n/m

n/m

Total Revenue

30,672

28,045

9

6

15,384

14,457

6

5

Cost of sales

(5,201)

(4,714)

10

3

(2,523)

(2,473)

2

3

Gross profit

25,471

23,331

9

7

12,861

11,984

7

5

Distribution expense

(286)

(278)

3

(3)

(145)

(143)

2

(2)

R&D expense

(7,545)

(6,707)

12

10

(4,053)

(3,548)

14

13

SG&A expense

(10,571)

(9,356)

13

10

(5,651)

(4,864)

16

14

Other operating income & expense

341

192

77

76

152

79

92

93

Operating profit

7,410

7,182

3

2

3,164

3,508

(10)

(13)

Net finance expense

(675)

(636)

6

2

(355)

(371)

(4)

(8)

Joint ventures and associates

(22)

(17)

28

19

(10)

(10)

(8)

(11)

Profit before tax

6,713

6,529

3

2

2,799

3,127

(11)

(13)

Taxation

(1,124)

(1,160)

(3)

(4)

(291)

(679)

(57)

(57)

Tax rate

17%

18%

10%

22%

Profit after tax

5,589

5,369

4

3

2,508

2,448

2

(2)

Earnings per share

$

3.60

$

3.46

4

3

$

1.61

$

1.58

2

(2)

Table 9: Reconciliation of Reported Profit before tax to EBITDA

H1 2026

H1 2025

% Change

​

​

Q2 2026

Q2 2025

% Change

​ ​ ​

$m

​ ​ ​

$m

​ ​ ​

Actual

​ ​ ​

CER

​

​

$m

​ ​ ​

$m

​ ​ ​

Actual

​ ​ ​

CER

Reported Profit before tax

6,713

6,529

3

2

2,799

3,127

(11)

(13)

Net finance expense

675

636

6

2

355

371

(4)

(8)

Joint ventures and associates

22

17

28

19

10

10

(8)

(11)

Depreciation, amortisation and impairment

3,295

2,673

23

21

1,928

1,389

39

38

EBITDA

10,705

9,855

9

7

5,092

4,897

4

1

Table 10: Reconciliation of Reported to Core financial measures: H1 2026

Intangible Asset

Amortisation &

Reported

Restructuring

Impairments

Other

Core

% Change

For the half year ended 30 June

$m

$m

$m

$m

$m

Actual

CER

Gross profit

​ ​ ​

25,471

​ ​ ​

(3)

​ ​ ​

16

​ ​ ​

3

​ ​ ​

25,487

​ ​ ​

9

​ ​ ​

7

– Gross Margin

83%

83%

–

+1pp

Distribution expense

(286)

–

–

–

(286)

3

(3)

R&D expense

(7,545)

57

364

1

(7,123)

9

6

– R&D % of Total Revenue

25%

23%

–

–

SG&A expense

​ ​ ​

(10,571)

​ ​ ​

106

​ ​ ​

2,156

​ ​ ​

400

​ ​ ​

(7,909)

​ ​ ​

9

​ ​ ​

6

– SG&A % of Total Revenue

34%

26%

–

–

Total operating expense

(18,402)

163

2,520

401

(15,318)

9

6

Other operating income & expense

341

–

–

–

341

82

81

Operating profit

7,410

160

2,536

404

10,510

12

11

– Operating Margin

24%

34%

+1pp

+1pp

Net finance expense

(675)

–

–

54

(621)

20

15

Taxation

(1,124)

(40)

(514)

(111)

(1,789)

10

9

EPS

$

3.60

$

0.08

$

1.31

$

0.22

$

5.21

12

11

(Press release, AstraZeneca, JUL 27, 2026, View Source [SID1234669427])

On July 27, 2026 argenx (Euronext & Nasdaq: ARGX), a global immunology innovation company, and Forte Biosciences, Inc. (Nasdaq: FBRX) reported that the companies have entered into a definitive agreement under which argenx will acquire Forte Biosciences for $77 per share in cash, representing a total equity value of approximately $2.2 billion.

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FB102, Forte Biosciences’ lead program, expands argenx’s portfolio of differentiated immunology medicines, adding a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases. The acquisition reflects argenx’s disciplined approach to identifying and advancing breakthrough science for patients with the potential to redefine standards of care in diseases that have lacked meaningful innovation for decades.

"Our Vision 2030 strategy is well-defined and on track, and our discovery, development and commercialization engines are delivering real value for patients," said Karen Massey, Chief Executive Officer of argenx. "The acquisition of Forte Biosciences builds on the strength of that foundation and advances our ambition to be the leading immunology innovator of the future. The addition of FB102 to our portfolio aligns perfectly with the argenx playbook: compelling biology, strong clinical validation and broad potential to address patient need. I am grateful to the Forte Biosciences team for their outstanding work. Together, we look forward to unlocking the full potential of FB102 and accelerating its impact for patients."

"We are incredibly proud of what we have achieved in advancing FB102 through clinical development and firmly believe that argenx is the ideal strategic partner to unlock the full potential of this novel anti-CD122 antibody across a broad range of autoimmune diseases," said Paul A. Wagner, Ph.D., Chief Executive Officer and Chairperson of the Board of Forte Biosciences. "By combining FB102’s promising clinical profile with argenx’s proven development expertise, global reach and commercial capabilities, we have a unique opportunity to accelerate its development and maximize its impact for patients living with vitiligo, celiac disease, alopecia areata and other autoimmune conditions. We are excited about the future of FB102 and the potential to bring this innovative therapy to many more patients worldwide."

Forte Biosciences recently reported positive Phase 1b data in vitiligo, demonstrating statistically significant treatment benefit. In addition, positive FB102 Phase 1b data in celiac disease was shared last year, with Phase 2 data expected in the second half of this year. These studies were key drivers of argenx’s decision to move from strategic investment to acquisition, providing clinical evidence in indications with significant unmet need and limited treatment options. Beyond celiac disease and vitiligo, FB102 has the potential to address alopecia areata and additional autoimmune diseases, supporting its profile as a potential pipeline-in-a-product opportunity.

FB102 complements argenx’s existing portfolio of antibody-based programs, including efgartigimod, empasiprubart, adimanebart, and ARGX-121, as well as several additional early-stage molecules, by adding a mechanism focused on pathogenic T-cell and NK-cell activity, broadening the company’s ability to pursue diseases driven by different dimensions of the immune system.

Transaction Terms

Under the terms of the merger agreement, argenx, through a wholly owned subsidiary, will commence a cash tender offer to acquire all of the outstanding shares of Forte Biosciences’ common stock at a price of $77 per share, representing a total equity value of approximately $2.2 billion and a premium of approximately 86% to Forte Biosciences’ volume-weighted average price (VWAP) since reporting positive Phase 1b data in vitiligo on July 9, 2026.

The consummation of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Forte Biosciences, and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful completion of the tender offer, a wholly owned subsidiary of argenx will merge with Forte Biosciences and the outstanding Forte Biosciences shares not tendered in the tender offer will be converted into the right to receive the same $77 per share in cash paid in the tender offer. The transaction is not subject to a financing condition and will be funded entirely from cash on hand.

The boards of directors of both companies have approved the transaction. The acquisition is expected to close in Q3 2026, subject to customary closing conditions.

(Press release, argenx, JUL 27, 2026, View Source [SID1234669425])

On July 24, 2026 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that the first patient has been successfully dosed in the dose-expansion phase of its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-redirected ARTEMIS T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

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Estrella’s dosing of the first patient in the dose-expansion cohort follows encouraging efficacy data from the dose-escalation cohort. At the 6-month assessment of evaluable Phase I patients with no CNS involvement, all patients who achieved complete response (CR) remained in CR.

"This marks an important milestone for Estrella and STARLIGHT-1," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "The sustained complete responses observed to date reinforce EB103’s potential to deliver best-in-class outcomes for patients with R/R B-cell NHL. We remain deeply committed to advancing EB103."

The expansion phase is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the recommended Phase II dose (RP2D) in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. Current active sites include UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, JUL 24, 2026, View Source [SID1234669417])

On July 24, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). The European Commission decision on this indication is anticipated later in 2026.

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Metastatic TNBC is an aggressive form of breast cancer that is associated with rapid disease progression and poor prognosis. Approximately 40% of metastatic TNBC tumors are PD-L1 positive. These tumors are considered more aggressive and associated with shorter survival, creating urgency to initiate treatment with effective regimens as soon as possible. For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment.

"People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1," said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. "This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status."

The CHMP’s recommendation is based on data from the Phase 3 ASCENT-04 study/KEYNOTE-D19 which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment in PD-L1 positive patients. In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1 positive metastatic TNBC. The ASCENT-04/KEYNOTE-D19 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed.

"Building on our established leadership in metastatic TNBC, this positive opinion reinforces our commitment to the breast cancer community," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "People with metastatic TNBC desperately need new options as early as possible. This positive opinion, coupled with the recent EMA approval of Trodelvy monotherapy, is an important step in changing outcomes for these patients."

The European Commission has approved the use of Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.

The U.S. Food and Drug Administration (FDA) has approved Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC. Trodelvy is approved for: either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

KEYTRUDA and KEYTRUDA QLEX are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About Triple-Negative Breast Cancer

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is globally approved for use in certain patients with metastatic TNBC and pre-treated HR+HER2- metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression, including in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. INDICATIONS FOR TRODELVY

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:

Locally Advanced or Metastatic Triple-Negative Breast Cancer

First Line

As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later

For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and, if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to ≤Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).

In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).

In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38.

UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, JUL 24, 2026, View Source [SID1234669416])

On July 24, 2026 AstraZeneca and Daiichi Sankyo reported Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and subsequently published in The New England Journal of Medicine.1

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway."

In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factors of hormone receptor status, de novo or recurrent disease and PIK3CA mutation status.

The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a 1st-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

HER2-positive metastatic breast cancer
Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately, 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2-positive.5

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6-8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.10,11

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) followed by THP is approved in the US, China and Singapore as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, India, Israel, United Arab Emirates, Saudi Arabia, Korea and Singapore as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, JUL 24, 2026, View Source [SID1234669415])