On July 17, 2025 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2025 (Press release, Abbott, JUL 17, 2025, View Source [SID1234654420]).

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Second-quarter sales increased 7.4 percent on a reported basis, 6.9 percent on an organic basis, or 7.5 percent when excluding COVID-19 testing-related sales1.
Second-quarter GAAP diluted EPS of $1.01 and adjusted diluted EPS of $1.26, which excludes specified items and reflects double-digit growth compared to the prior year.
First-half sales increased 5.7 percent on a reported basis, 6.9 percent on an organic basis, or 7.9 percent when excluding COVID-19 testing-related sales2.
Abbott projects full-year 2025 organic sales growth, excluding COVID-19 testing-related sales, to be 7.5% to 8.0%, or 6.0% to 7.0% when including COVID-19 testing-related sales.
Abbott projects full-year 2025 adjusted diluted EPS of $5.10 to $5.20, which reflects double-digit growth at the midpoint.
In April, Abbott completed enrollment ahead of schedule in its FlexPulse U.S. IDE trial, which is designed to evaluate the TactiFlex Duo Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib).
In April, Abbott announced late-breaking data from the AVEIR Conduction System Pacing (CSP) clinical feasibility study. This study was the world’s first assessment of a leadless pacemaker delivering conduction pacing, which produces pacing that closely mimics the heart’s natural electrical rhythm and represents a new treatment option for people with irregular heart rhythms.
In May, Abbott announced U.S. Food and Drug Administration (FDA) approval of the company’s Tendyne transcatheter mitral valve replacement (TMVR) system, a first-of-its-kind device to help treat people with mitral valve disease.
Abbott has initiated plans to develop a new cardiovascular device manufacturing facility in the state of Georgia to be completed by 2028.
"Halfway through the year, we delivered high single-digit organic sales growth, double-digit EPS growth, significantly expanded our margin profiles, and continued to advance key programs through our new product pipeline," said Robert B. Ford, chairman and chief executive officer, Abbott. "We see this momentum carrying into 2026."

SECOND-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes thatmeasuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to bestunderstand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,276

957

811

—

2,503

International

6,866

1,255

1,362

1,383

2,866

Total reported

11,142

2,212

2,173

1,383

5,369

% Change vs. 2Q24

U.S.

8.7

2.6

(0.1)

n/a

14.6

International

6.6

3.1

(1.5)

6.9

12.4

Total reported

7.4

2.9

(1.0)

6.9

13.4

Impact of foreign exchange

0.5

(0.5)

0.4

(0.8)

1.2

Organic

6.9

3.4

(1.4)

7.7

12.2

Impact of COVID-19 testing sales 1

(0.6)

—

(2.2)

—

—

Organic (excluding COVID-19 tests)

7.5

3.4

0.8

7.7

12.2

Organic

U.S.

8.7

2.6

(0.1)

n/a

14.6

International

5.8

4.0

(2.2)

7.7

10.1

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

8,444

1,912

1,682

—

4,842

International

13,056

2,446

2,545

2,643

5,422

Total reported

21,500

4,358

4,227

2,643

10,264

% Change vs. 1H24

U.S.

8.5

5.6

(3.5)

n/a

14.8

International

3.9

1.6

(4.5)

4.9

9.1

Total reported

5.7

3.3

(4.1)

4.9

11.7

Impact of foreign exchange

(1.1)

(1.5)

(0.9)

(2.9)

(0.7)

Impact of business exit*

(0.1)

(0.3)

—

—

—

Organic

6.9

5.1

(3.2)

7.8

12.4

Impact of COVID-19 testing sales 2

(1.0)

—

(3.9)

—

—

Organic (excluding COVID-19 tests)

7.9

5.1

0.7

7.8

12.4

Organic

U.S.

8.7

6.4

(3.5)

n/a

14.8

International

5.8

4.1

(3.0)

7.8

10.3

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

957

587

370

International

1,255

467

788

Total reported

2,212

1,054

1,158

% Change vs. 2Q24

U.S.

2.6

4.2

0.2

International

3.1

(5.7)

9.2

Total reported

2.9

(0.4)

6.1

Impact of foreign exchange

(0.5)

(0.6)

(0.5)

Organic

3.4

0.2

6.6

U.S.

2.6

4.2

0.2

International

4.0

(4.5)

9.8

Worldwide Nutrition sales increased 2.9 percent on a reported basis and 3.4 percent on an organic basis in the second quarter.

Growth in the quarter was led by Adult Nutrition, where global sales increased 6.1 percent on a reported basis and 6.6 percent on an organic basis, led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Pediatric

Adult

U.S.

1,912

1,175

737

International

2,446

920

1,526

Total reported

4,358

2,095

2,263

% Change vs. 1H24

U.S.

5.6

9.0

0.6

International

1.6

(7.0)

7.7

Total reported

3.3

1.3

5.3

Impact of foreign exchange

(1.5)

(1.2)

(1.6)

Impact of business exit*

(0.3)

—

(0.7)

Organic

5.1

2.5

7.6

U.S.

6.4

9.0

2.4

International

4.1

(4.6)

10.2

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

811

351

35

104

321

International

1,362

1,007

88

44

223

Total reported

2,173

1,358

123

148

544

% Change vs. 2Q24

U.S.

(0.1)

7.3

5.5

(2.0)

(7.1)

International

(1.5)

0.5

(5.6)

(11.9)

(6.1)

Total reported

(1.0)

2.2

(2.7)

(5.1)

(6.7)

Impact of foreign exchange

0.4

0.6

0.7

0.1

0.1

Organic

(1.4)

1.6

(3.4)

(5.2)

(6.8)

U.S.

(0.1)

7.3

5.5

(2.0)

(7.1)

International

(2.2)

(0.3)

(6.5)

(12.1)

(6.3)

Global Diagnostics sales decreased 1.0 percent on a reported basis, decreased 1.4 percent on an organic basis, and increased 0.8 percent when excluding COVID-19 testing-related sales1.

Diagnostics sales growth was impacted by the year-over-year decline in COVID-19 testing-related sales and volume-based procurement programs in China.

COVID-19 testing-related sales were $55 million in the quarter, compared to $102 million in the second quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 2.2 percent on a reported basis and increased 1.6 percent on an organic basis. Growth in the quarter was impacted by volume-based procurement programs in China.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

1,682

683

75

204

720

International

2,545

1,852

170

86

437

Total reported

4,227

2,535

245

290

1,157

% Change vs. 1H24

U.S.

(3.5)

7.2

—

(0.3)

(12.8)

International

(4.5)

(2.4)

(6.1)

(4.5)

(12.3)

Total reported

(4.1)

0.1

(4.4)

(1.6)

(12.6)

Impact of foreign exchange

(0.9)

(1.2)

(1.0)

(0.4)

(0.6)

Organic

(3.2)

1.3

(3.4)

(1.2)

(12.0)

U.S.

(3.5)

7.2

—

(0.3)

(12.8)

International

(3.0)

(0.7)

(4.9)

(3.3)

(10.7)

Established Pharmaceuticals

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,383

1,059

324

Total reported

1,383

1,059

324

% Change vs. 2Q24

U.S.

n/a

n/a

n/a

International

6.9

7.3

5.9

Total reported

6.9

7.3

5.9

Impact of foreign exchange

(0.8)

(1.4)

1.4

Organic

7.7

8.7

4.5

U.S.

n/a

n/a

n/a

International

7.7

8.7

4.5

Established Pharmaceuticals sales increased 6.9 percent on a reported basis and 7.7 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 7.3 percent on a reported basis and 8.7 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

2,643

2,024

619

Total reported

2,643

2,024

619

% Change vs. 1H24

U.S.

n/a

n/a

n/a

International

4.9

5.7

2.4

Total reported

4.9

5.7

2.4

Impact of foreign exchange

(2.9)

(3.3)

(1.4)

Organic

7.8

9.0

3.8

U.S.

n/a

n/a

n/a

International

7.8

9.0

3.8

Medical Devices

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,503

340

322

282

283

289

193

794

International

2,866

333

378

86

474

347

61

1,187

Total reported

5,369

673

700

368

757

636

254

1,981

% Change vs. 2Q24

U.S.

14.6

16.5

12.2

15.8

3.0

12.2

0.4

24.5

International

12.4

5.7

10.9

11.2

5.4

13.7

20.4

17.5

Total reported

13.4

10.9

11.5

14.7

4.5

13.0

4.6

20.2

Impact of foreign exchange

1.2

1.1

1.2

0.7

1.0

1.3

0.3

1.7

Organic

12.2

9.8

10.3

14.0

3.5

11.7

4.3

18.5

U.S.

14.6

16.5

12.2

15.8

3.0

12.2

0.4

24.5

International

10.1

3.6

8.8

8.4

3.8

11.4

18.7

14.7

Worldwide Medical Devices sales increased 13.4 percent on a reported basis and 12.2 percent on an organic basis in the second quarter.

Sales growth in the quarter was led by double-digit growth in Diabetes Care, Heart Failure, Structural Heart and Electrophysiology.

Several products contributed to the strong performance, including FreeStyle Libre, Navitor, TriClip and AVEIR.

In Diabetes Care, sales of continuous glucose monitors were $1.9 billion and grew 21.4 percent on a reported basis and 19.6 percent on an organic basis.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

4,842

644

621

544

551

571

369

1,542

International

5,422

614

708

163

916

642

113

2,266

Total reported

10,264

1,258

1,329

707

1,467

1,213

482

3,808

% Change vs. 1H24

U.S.

14.8

14.4

11.7

13.2

4.2

16.3

(1.1)

25.7

International

9.1

1.2

7.6

12.6

3.5

9.3

18.5

13.8

Total reported

11.7

7.6

9.5

13.1

3.8

12.5

2.9

18.4

Impact of foreign exchange

(0.7)

(0.4)

(0.6)

(0.2)

(0.7)

(0.7)

(0.4)

(0.7)

Organic

12.4

8.0

10.1

13.3

4.5

13.2

3.3

19.1

U.S.

14.8

14.4

11.7

13.2

4.2

16.3

(1.1)

25.7

International

10.3

2.0

8.8

13.4

4.8

10.5

20.5

15.0

ABBOTT’S FINANCIAL GUIDANCE
Abbott projects full-year 2025 organic sales growth, excluding COVID-19 testing related sales, to be 7.5% to 8.0%, or 6.0% to 7.0% when including COVID-19 testing-related sales.

Abbott projects full-year 2025 adjusted operating margin to be approximately 23.5% of sales.

Abbott projects full-year 2025 adjusted diluted earnings per share of $5.10 to $5.20 and third-quarter 2025 adjusted diluted earnings per share of $1.28 to $1.32.

Abbott has not provided the related GAAP financial measures on a forward-looking basis for these forward-looking non-GAAP financial measures because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items such as restructuring and cost reduction initiatives, charges for intangible asset impairments, acquisition-related expenses, and foreign exchange, which could significantly impact Abbott’s results in accordance with GAAP.

ABBOTT DECLARES 406th CONSECUTIVE QUARTERLY DIVIDEND
On June 13, 2025, the board of directors of Abbott declared the company’s quarterly dividend of $0.59 per share. Abbott’s cash dividend is payable Aug. 15, 2025, to shareholders of record at the close of business on July 15, 2025.

Abbott has increased its dividend payout for 53 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On July 17, 2025 MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, reported that the first patient has been dosed in its Phase 1 clinical trial to assess the safety and tolerability of MOMA-341, a potent and selective Werner helicase inhibitor with a novel chemical scaffold (Press release, MOMA Therapeutics, JUL 17, 2025, View Source [SID1234654436]).

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MOMA-341 is being developed as a monotherapy and in combination with chemotherapy or immunotherapy for the treatment of advanced or metastatic solid tumors that exhibit high microsatellite instability (MSI-H) and/or DNA mismatch repair deficiency (dMMR), including colorectal, gastric and endometrial cancers. The fact that Werner helicase is required for survival of MSI-H/dMMR tumor cells makes it a promising emerging drug target. MOMA anticipates an initial readout of monotherapy data in mid-2026.

"We are proud to enter the clinic for the second time in less than a year, with initial readouts for both MOMA-341 and MOMA-313, our novel Polθ helicase inhibitor, expected in early-to- mid 2026," said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. "Given that MOMA-341’s novel chemical scaffold confers excellent target coverage, we are eager to evaluate its best-in-class potential for patients through this Phase 1 study."

About the MOMA-341 Phase 1 Trial

The Phase 1 clinical trial is a global multi-center, open-label dose escalation and dose optimization study (NCT06974110) designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical activity of MOMA-341 as an orally administered single agent or combination therapy with either the chemotherapy agent irinotecan or immunotherapy. Adult participants must have unresectable advanced or metastatic microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.

About the KNOMATIC platform

MOMA-341 and MOMA-313, were discovered and developed through the application of MOMA’s KNOMATIC platform. The KNOMATIC platform integrates deep structural insights, advanced hit-finding technologies and computation-enabled lead optimization to accelerate discovery of novel therapeutics targeting families of highly dynamic proteins, such as ATPases and GTPases.

On July 17, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported that it entered into a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd. (Bridge Health) (Press release, I-Mab Biopharma, JUL 17, 2025, View Source [SID1234654422]). The transaction provides I-Mab with the rights to bispecific and multi-specific applications (including bispecific and multi-specific antibodies and antibody drug conjugates (ADCs)), based on the Claudin 18.2 (CLDN18.2) parental antibody used in the Company’s CLDN18.2 x 4-1BB bispecific antibody, givastomig.

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"Advancing givastomig is I-Mab’s top priority. The strategic acquisition of Bridge Health emphasizes I-Mab’s focus on enhancing the value of givastomig. With this transaction, I-Mab has further enriched the potential value of givastomig by strengthening upstream intellectual property rights, reducing future milestone payments, and unencumbering givastomig of future royalties," said Sean Fu, PhD, MBA, Chief Executive Officer of I-Mab. "Positive Phase 1b dose escalation data recently presented at ESMO (Free ESMO Whitepaper) GI 2025 has enhanced our confidence that givastomig has the potential to be a best-in-class CLDN18.2-directed therapy for gastric cancers and beyond. Continued clinical trial momentum has enabled faster than expected enrollment in the Phase 1b dose expansion cohorts, and we now expect to provide a topline readout in Q1 of 2026."

The CLDN18.2 parental antibody utilized in givastomig has been observed to show a higher affinity to human CLDN18.2 than other antibodies, including antibodies used in approved CLDN18.2-directed therapies. Additionally, the CLDN18.2 parental antibody has been observed to exhibit stronger binding affinity to cell lines expressing high, medium and even low levels of CLDN18.2. These characteristics are believed to be core to the differentiation of givastomig as a potential best-in-class, bispecific antibody designed to treat Claudin 18.2-positive cancers.

Givastomig is in development for the treatment of first line metastatic gastric cancers, with potential to expand into other solid tumors. Recently presented positive data from a Phase 1b dose escalation immunochemotherapy combination study showed an 83% objective response rate (ORR) in the doses selected for dose expansion cohorts, with favorable overall tolerability. I-Mab expects to present topline results from the Phase 1b dose expansion combination study in Q1 of 2026.

Transaction Terms

Under the terms of the agreement, I-Mab will pay Bridge Health shareholders an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027. In addition, Bridge Health shareholders may receive future milestone payments of up to $3.875 million, subject to the achievement of certain development and regulatory milestones. The transaction is expected to close in Q3 of 2025.

Sidley Austin LLP served as legal advisor to I-Mab in connection with the transaction.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Data from the dose escalation cohorts (n=17), presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI 2025) showed an 83% objective response rate (ORR) at doses selected for dose expansion, with responses in patients with low PD-L1 and CLDN18.2 expression. Responses were rapid, durable and deepened over time, with a favorable overall safety profile. Enrollment in the first dose expansion cohort (n=20) finished ahead of schedule and enrollment in the second dose expansion cohort (n=20) is nearly complete. Topline data are expected in Q1 of 2026.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

On July 17, 2025 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations (Press release, GlaxoSmithKline, JUL 17, 2025, View Source [SID1234654423]). The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

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The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July 2025 PDUFA date.

GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival.

Blenrep combinations are approved in relapsed or refractory multiple myeloma in the UK1 and Japan2, as well as other markets, including Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the European Union3, and China4 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Multiple myeloma is a significant and enduring health concern in the US, where more than 35,000 cases were diagnosed in 2024.8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.10,11

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
Blenrep combinations were approved in relapsed or refractory multiple myeloma in the UK in April 2025 and in Japan in May 2025. Applications are currently under review in all major markets.

In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets available on the MHRA Products website.12

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was progression-free survival (PFS) as per an independent review committee, with secondary endpoints including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.13,14

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

At the primary analysis at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

With additional follow-up, a clinically meaningful benefit continued to be observed, with a near-tripling of the median PFS for the Blenrep combination versus the bortezomib combination (32.6 months versus 12.5 months, respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.15 Updated PFS results were presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) 2025.

On July 17, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, and HekaBio K.K., headquartered in Chuo-ku, Tokyo ("HekaBio"), reported a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan following HekaBio’s recently announced investment in common equity of NKGen (Press release, NKGEN Biotech, JUL 17, 2025, View Source [SID1234654424]).

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HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan’s Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer’s and Parkinson’s Diseases.

As troculeucel is an autologous, non-genetically modified cell therapy, there is allowance under regenerative medicine regulations in Japan to offer this therapy to patients on an accelerated path, much faster than in other major markets. HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months. Beyond intractable disease, troculeucel has the potential to also support Japan’s aging population in the longevity/wellness space.

"Japan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses," said Paul Y. Song, MD, Chairman and Chief Executive Officer ("CEO") of NKGen. "I am convinced that HekaBio’s clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio."

"Dementia, particularly Alzheimer’s Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country’s aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society," said Rob Claar, CEO of HekaBio.