Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline

On October 26, 2025 Novartis reported that it has entered into an agreement to acquire Avidity Biosciences, Inc. (Nasdaq: RNA), a San Diego-based, biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The acquisition will follow the separation of Avidity’s early-stage precision cardiology programs.

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Avidity is committed to delivering a new class of pioneering RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) for serious, genetic neuromuscular diseases. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions.

"Avidity’s pioneering AOC platform for RNA therapeutics ​and its late-stage assets bolster our commitment to delivering innovative, targeted and potentially first-in-class medicines to treat devastating, progressive neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "The Avidity team has built robust programs with industry-leading delivery of RNA therapeutics to muscle tissue. We look forward to developing these programs to meaningfully change the trajectory of diseases for patients."

The proposed acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Accelerating innovative RNA science and AOC therapies for patients with neuromuscular disease
The proposed acquisition aligns with the long-term neuroscience strategy of Novartis, expanding the company’s pipeline with potential near-term launches in genetically defined diseases with high unmet need. The Avidity programs feature potential first-in-class, late-stage disease-modifying therapies in myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying therapies; facioscapulohumeral muscular dystrophy (FSHD), a rare hereditary disorder causing relentless loss of muscle function and progressive disability; and Duchenne muscular dystrophy (DMD), a severe, early-onset disease marked by progressive muscle damage and reduced life expectancy.

The proposed acquisition is expected to create an industry-leading pipeline, building on the Novartis expertise in spinal muscular atrophy and commercialization capabilities in genetic neuromuscular diseases. Avidity aims to deliver meaningful patient benefits by addressing root genetic causes, restoring muscle function, and potentially slowing disease progression. Its AOC platform combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides, enabling targeted delivery to previously hard-to-reach muscle cells. AOCs carry disease-specific, oligonucleotide payloads intended to correct underlying genetic mechanisms and enable targeted, disease-modifying therapies with the potential to have significant impact on patient lives.

Transaction details
Under the terms of the transactions, which have been unanimously approved by the Boards of Directors of both companies, Novartis, through a merger with a newly formed indirect wholly owned subsidiary, will acquire all outstanding shares of Avidity. Pursuant to the terms of the merger agreement, holders of Avidity common stock will receive USD 72.00 per share in cash at closing, representing a premium of 46% to the closing share price on October 24, 2025, and valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn at the expected closing date.

Prior to the closing of the merger, Avidity will transfer to SpinCo, a wholly owned subsidiary of Avidity, the early-stage precision cardiology programs and collaborations of Avidity. The transfer includes certain Avidity assets whose transfer will trigger a right of first negotiation with an existing collaboration partner of Avidity. Holders of Avidity common stock will receive (1) a distribution of one share of SpinCo for every ten shares of Avidity they hold and/or (2) a pro rata cash distribution of the proceeds received by Avidity prior to the closing if certain SpinCo assets are, or SpinCo itself is, sold to a third party.

The acquisition by Novartis of Avidity is subject to the completion of a spin-off or a sale of SpinCo and other customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity stockholders. The companies expect the merger to close in the first half of 2026. Until closing, Novartis and Avidity will continue to operate as separate and independent companies.

Novartis Investor Call
Novartis will host a conference call for investors to discuss the transaction on October 27, 2025 at 1 pm CET. Details can be found at View Source

(Press release, Novartis, OCT 26, 2025, View Source [SID1234657019])

WuXi AppTec Achieves Strong Double-Digit Growth in Revenue and Profit for Q1-Q3 2025 Backlog for Continuing Operations Up 41.2% YoY Further Raises 2025 Full-year Guidance

On October 26, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, reported financial results for the first three quarters ending September 30, 2025 ("Reporting Period"):

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For the first three quarters of 2025, total revenue reached RMB32.86 billion, up 18.6% year-over-year. Revenue from Continuing Operations reached RMB32.45 billion, up 22.5% year-over-year.
Adjusted non-IFRS gross profit reached RMB15.46 billion, with the adjusted non-IFRS gross profit margin up 6.1pts year-over-year to 47.0%.
Net profit attributable to the owners of the Company was RMB12.08 billion, up 84.8% year-over-year; diluted EPS was RMB4.21, up 87.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB10.54 billion, up 43.4% year-over-year; adjusted non-IFRS net profit margin up 5.6pts year-over-year to 32.1%; adjusted non-IFRS diluted EPS was RMB3.68, up 46.0% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB59.88 billion as of September 30, 2025, up 41.2% year-over-year.
Operating cash flow climbed 35.0% year-over-year to RMB10.87 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
Sustained and steady business growth as a result of our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. Driven by "follow the molecule" and "win the molecule" strategies, WuXi Chemistry’s small molecule CRDMO pipeline continues to efficiently convert and capture high-quality molecules, delivering sustained business growth. In the first three quarters of 2025, a total of 621 new molecules were added to the small molecule Development and Manufacturing (D&M) pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, representing an increase of 15 projects in phase III and commercial stages during the first three quarters of 2025.
Acceleration of global expansion, capacity construction and capability development. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. By the end of 2025, total reactor volume of small molecule APIs is expected to reach over 4,000kL. In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
Robust shareholder returns. The Company remains committed to rewarding shareholders and actively supporting the Company’s value. This year, the Company has implemented a total of RMB6.88 billion in cash dividends, share repurchases and cancellations, representing more than 70% of the Company’s 2024 net profit attributable to the owners of the Company. Among these, the Company has distributed a total of RMB4.88 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend, RMB1.01 billion for the 2025 special cash dividend and RMB1.03 billion for the 2025 interim dividend. Meanwhile, the Company also completed the repurchase of RMB2.0 billion worth of A-shares in total, all of which have been cancelled.
[1] As disclosed in 2025 Third Quarterly Report, Continuing Operations include WuXi Chemistry, WuXi Testing, WuXi Biology and Others, the scope of which may change following adjustments to the Company’s business strategy.

[2] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[3] In 2024 Q1-Q3 and 2025 Q1-Q3, WuXi AppTec had a fully-diluted weighted average share count of 2,906,724,914 and 2,873,641,499 ordinary shares, respectively.

2025 Full-Year Outlook

With confidence in customers’ ongoing demand for enabling services, our CRDMO business model and management execution, the Company has further raised its full-year guidance.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 17-18%, up from the prior 13-17%. As a result, the Company expects full-year total revenue of RMB43.5-44.0 billion, up from the prior RMB42.5-43.5 billion.

As it focuses on the core CRDMO business and continuously improved production and operating efficiency, the Company is confident and expects to further improve the adjusted non-IFRS net profit margin in 2025.

The Company is actively advancing global capacity construction; while due to longer-than-expected settlement cycles of certain projects, capex for 2025 is expected to reach RMB5.5-6.0 billion (adjusted from the prior RMB7.0-8.0 billion). Together with business growth, efficiency improvement, and considering the timing differences in project payments, free cash flow for 2025 is expected to increase from RMB5.0-6.0 billion to RMB8.0-8.5 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Reflecting robust customer demand and the strength of our unique CRDMO business model, WuXi AppTec delivered strong double-digit growth in revenue, profit and operating cash flow in the first three quarters of 2025, while our backlog for Continuing Operations reached a record RMB59.9 billion. Based on this momentum, we have further raised our full-year revenue and free cash flow guidance. The strategic divestment of clinical research services enables us to fully focus on our core CRDMO strategy and better meet the evolving needs of our customers. By concentrating on drug discovery, laboratory testing, process development, and manufacturing services, we are accelerating the growth of our global capabilities and capacities, delivering greater value for customers and shareholders, and advancing our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segment

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; Q1-Q3 2025 Revenue Up 29.3 % YoY , with TIDES Revenue Up 121.1% YoY
Q1-Q3 revenue of WuXi Chemistry reached RMB25.98 billion, up 29.3% year-over-year. With continued optimization of production process and improvement in capacity efficiency driven by the growth of late-stage clinical and commercial projects, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Chemistry steadily improved 5.8pts year-over-year to 51.3%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 430,000 new compounds to customers. In the meantime, 250 molecules were converted from R to D phase in the first three quarters of 2025. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business.
Small molecule D&M service remains strong.
The small molecule CDMO pipeline continued to expand. Q1-Q3 revenue of small molecule D&M services rose 14.1% year-over-year to RMB14.24 billion. In the first three quarters of 2025, 621 new molecules were added to the small molecule D&M pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, including 80 commercial projects, 87 in phase III, 374 in phase II and 2,889 in phase I and pre-clinical stages. This represents an increase of 15 projects in the commercial and phase III stages during the first three quarters of 2025.
We continued to build small molecule capacity. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by the end of 2025.
TIDES business (oligo and peptides) sustains rapid growth.
With the ramp-up of new capacities released sequentially each quarter last year, Q1-Q3 TIDES revenue grew 121.1% year-over-year to RMB7.84 billion. As of September 30, 2025, TIDES backlog grew 17.1% year-over-year.
TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 34% year-over-year.
In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
WuXi Testing: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB4.17 billion in Q1-Q3, and Q1-Q3 adjusted non-IFRS gross profit margin was 26.5%.
With development of differentiated capabilities and enhanced operational management, Q3 revenue of lab testing services reached RMB1.08 billion, growing 7.2% year-over-year and 7.5% quarter-over-quarter; while its Q3 adjusted non-IFRS gross profit margin continued to improve quarter-over-quarter. Of which, the revenue of drug safety evaluation services grew 5.9% year-over-year and 13.2% quarter-over-quarter.
Q1-Q3 revenue of lab testing services grew 2.7% year-over-year to RMB2.96 billion. Due to market impact, its Q1-Q3 adjusted non-IFRS gross profit margin declined as pricing was gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue resumed positive year-over-year growth, while maintaining an industry-leading position in the Asia-Pacific region.
The Company is committed to actively enabling customers’ global licensing. New modality business continued to develop, while the Company maintained its leading position in areas including nucleic acids, conjugates, mRNA, multispecific antibodies and peptides.
The Company continued to advance automation. DMPK successfully launched its proprietary all-in-one compound identification software, enhancing efficiency in spectral interpretation and metabolite identification for nucleic acids and peptides by 83%.
The Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1-Q3 revenue for clinical CRO & SMO was down 6.4% year-over-year to RMB1.21 billion due to market pricing impact; of which, SMO revenue was down 0.7% year-over-year as backlog gradually converted into revenue, while maintaining its industry leading position in China.
During the first three quarters of 2025, our clinical CRO business supported customers in obtaining 19 IND approvals and submitting for 2 NDA filings; the SMO business supported 75 new drug approvals for customers. The SMO business has supported 331 new drug approvals in total over the past decade, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
WuXi Biology: Continues to Generate Downstream Opportunities; In Vitro & In Vivo Business Synergies and New Modality Business Drive Growth
WuXi Biology follows the science, continuously strengthens drug discovery capabilities in emerging areas and actively grows overseas businesses. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through cross-regional collaboration, comprehensive platform integration and integrated project transformation, we efficiently enable our customers worldwide. WuXi Biology revenue reached RMB1.95 billion in Q1-Q3 2025, a year-over-year increase of 6.6%.
Due to market pricing impact, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Biology was down 1.0pts to 37.0%. With continuously improved operational efficiency, its Q3 adjusted non-IFRS gross profit margin improved 1.5pts quarter-over-quarter.
We accelerated advancements in in vitro integrated screening technologies and continued to improve in vivo pharmacology capabilities, resulting in rapid year-over-year and quarter-over-quarter revenue growth. With its competitive edge continuously strengthened, the non-oncology business has achieved strong revenue growth, becoming an important contributor to business growth.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2025 Third Quarterly Results Presentation and 2025 Third Quarterly Report disclosed on the Company’s official website, as well as the Company’s disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRSs"), in currency of RMB.

The 2025 Third Quarterly Report of the Company has not been audited.

Third Quarter 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross Profit
Margin

WuXi Chemistry

9,676.68

22.7 %

5,329.83

40.6 %

55.1 %

WuXi Testing

1,480.83

2.1 %

428.69

-10.0 %

28.9 %

WuXi Biology

695.67

5.9 %

264.49

1.8 %

38.0 %

Others

191.78

163.8 %

161.60

658.4 %

84.3 %

Discontinued Operations (Note 1)

12.47

-96.9 %

12.47

N/A

100.0 %

Total

12,057.43

15.3 %

6,197.08

38.4 %

51.4 %

First Three Quarters 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross
Profit
Margin

WuXi Chemistry

25,978.06

29.3 %

13,314.69

45.7 %

51.3 %

WuXi Testing

4,169.47

0.0 %

1,104.58

-26.1 %

26.5 %

WuXi Biology

1,947.27

6.6 %

720.38

3.8 %

37.0 %

Others

355.26

-10.5 %

258.90

24.1 %

72.9 %

Discontinued Operations (Note 1)

406.65

-66.5 %

56.49

N/A

13.9 %

Total

32,856.72

18.6 %

15,455.04

36.3 %

47.0 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed or sales were completed during the first three quarters of 2025 or the comparison year as discontinued operations.

Note 2: Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss [4] – Prepared under IFRSs

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Revenue

12,057.4

10,461.1

32,856.7

27,702.0

Cost of sales

(6,050.8)

(6,063.8)

(17,737.9)

(16,603.8)

Gross profit

6,006.6

4,397.3

15,118.9

11,098.2

Other income

280.4

247.6

920.0

758.6

Other gains and losses

188.0

(602.5)

2,637.0

(394.1)

Impairment losses under expected credit losses

("ECL") model, net of reversal

(169.0)

(72.5)

(459.6)

(154.6)

Impairment losses of non-financial assets

(80.0)

(153.5)

Impairment losses of assets classified as held for sale

(120.7)

Selling and marketing expenses

(175.0)

(189.1)

(569.4)

(546.6)

Administrative expenses

(721.8)

(687.4)

(1,969.5)

(1,964.9)

R&D expenses

(311.2)

(317.7)

(825.7)

(954.0)

Operating Profit

5,018.1

2,775.7

14,577.4

7,842.5

Share of results of associates

199.9

87.1

440.1

202.9

Share of results of joint ventures

0.6

0.2

0.6

(4.0)

Finance costs

(88.8)

(58.2)

(257.6)

(187.2)

Profit before tax

5,129.7

2,804.7

14,760.5

7,854.3

Income tax expense

(1,583.8)

(484.0)

(2,830.9)

(1,252.7)

Profit for the period

3,545.8

2,320.8

11,929.6

6,601.6

Profit for the period attributable to:

Owners of the Company

3,514.6

2,293.1

11,801.9

6,532.9

Non-controlling interests

31.2

27.7

127.6

68.7

3,545.8

2,320.8

11,929.6

6,601.6

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Profit or Loss[5] (continued) – Prepared under IFRSs

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,839,378,755

2,883,580,115

2,839,864,290

2,899,626,297

– Diluted

2,877,629,997

2,889,573,492

2,873,641,499

2,906,724,914

Earnings per share (expressed in RMB per S hare)

– Basic

1.24

0.80

4.16

2.25

– Diluted

1.22

0.79

4.12

2.24

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position[6] – Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,662.5

25,267.8

Right-of-use assets

1,837.0

1,874.8

Goodwill

866.0

972.4

Other intangible assets

420.1

601.0

Interests in associates

1,939.2

2,322.2

Interests in joint ventures

3.9

3.4

Deferred tax assets

512.9

473.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,350.8

8,943.4

Other non-current assets

115.7

114.7

Biological assets

1,085.7

1,063.0

Total Non-current Assets

40,793.8

41,635.7

Current Assets

Inventories

6,011.0

3,532.1

Contract costs

929.0

912.2

Biological assets

903.7

955.5

Amounts due from related parties

115.5

89.3

Trade and other receivables

10,731.6

9,643.7

Contract assets

819.0

988.8

Income tax recoverable

42.8

87.2

Financial assets at FVTPL

3,561.0

1,234.0

Derivative financial instruments

1.8

Other current assets

742.3

734.1

Pledged bank deposits

57.5

22.1

Term deposits with initial term of over three
months

3,921.4

4,865.6

Bank balances and cash

25,459.9

13,434.3

53,296.6

36,498.8

Assets classified as held for sale

515.7

2,191.3

Total Current Assets

53,812.3

38,690.2

Total Assets

94,606.1

80,325.8

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[7]– Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,746.5

7,025.5

Amounts due to related parties

7.9

15.3

Derivative financial instruments

2.9

202.0

Contract liabilities

2,565.7

2,251.0

Bank borrowings

5,282.1

1,278.6

Lease liabilities

179.9

224.2

Income tax payables

2,249.9

870.8

Convertible bonds

1,294.5

3,493.1

19,329.3

15,360.6

Liabilities directly associated with assets
classified as held for sale

109.0

865.5

Total Current Liabilities

19,438.3

16,226.1

Non-current Liabilities

Bank borrowings

1,799.1

2,959.5

Deferred tax liabilities

433.7

522.4

Deferred income

929.9

985.6

Lease liabilities

532.7

546.6

Total Non-current Liabilities

3,695.4

5,014.1

Total Liabilities

23,133.6

21,240.2

Net Assets

71,472.5

59,085.6

Capital and Reserves

Share capital

2,965.7

2,888.0

Reserves

67,982.4

55,744.7

Equity attributable to owners of the Company

70,948.1

58,632.7

Non-controlling interests

524.4

452.9

Total Equity

71,472.5

59,085.6

[7] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[8]

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Net p rofit attributable to the owners of the Company under CAS

3,514.6

2,293.1

12,075.5

6,532.9

GAAP difference[9]

(273.6)

Net p rofit attributable to the owners of the Company under IFRSs

3,514.6

2,293.1

11,801.9

6,532.9

Add:

Share-based compensation expenses

249.9

79.4

426.3

244.4

Issuance expenses of convertible bonds

8.7

28.4

Foreign exchange related losses

100.0

629.8

548.0

658.7

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.3

20.5

40.3

Gains or losses from divestiture, restructuring and resource
integration initiatives

88.4

228.3

Non-IFRS net profit attributable to the owners of the Company

3,968.5

3,015.6

13,053.5

7,476.3

Add:

Realized and unrealized losses(gains) from venture capital
investments

254.4

(41.9)

(2,515.7)

(134.6)

Realized and unrealized share of (gains)losses from joint ventures

(0.6)

(0.2)

(0.6)

4.0

Adjusted non-IFRS net profit attributable to the owners of the
Company

4,222.3

2,973.5

10,537.1

7,345.7

(Press release, WuXi AppTec, OCT 26, 2025, View Source [SID1234657022])

Guardant Health to Share Data Supporting Critical Role of Blood-Based Testing in Improving Cancer Screening Adherence at ACG 2025

On October 26, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data showing the critical role of blood-based testing in increasing cancer screening adherence at the American College of Gastroenterology (ACG) 2025 Annual Meeting in Phoenix, Arizona taking place Friday, October 24 – Wednesday, October 29, 2025.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Building off findings from Guardant Health’s 2023 ACG abstract, a study of an expanded cohort of 20,000 patients confirmed findings from earlier reports on the effectiveness of the Shield blood-based screening test in improving adherence to colorectal cancer (CRC) screening. Shield is the first and only blood test to receive FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. The findings demonstrated an over 90% adherence rate for Shield, tracking well above average screening adherence for overall CRC testing which ranges from 28-71%. 1-4

A separate study led by researchers at Cedars Sinai found that individuals prefer a blood test for colorectal cancer and lung cancer over other methods, showing the potential for an innovative blood test like Shield to increase the overall screening rate in lung cancer screening. The survey found that more screening-eligible individuals (43.9%) prefer to do a blood test for colorectal cancer and lung cancer compared to traditional screenings.

"Today’s research reinforces what Guardant has long believed: blood-based cancer screening is the future," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "These studies highlight the power of a simple blood test in addressing today’s gaps in colorectal cancer screening adherence and potential to expand to an even broader population looking for a more pleasant option for their regular lung cancer screening. We’re eager to present these findings along with our research collaborators at the ACG meeting and proud to offer Shield, an FDA-approved test, as an accessible and convenient alternative to traditional screening methods."

Guardant Health and collaborator presentations at ACG 2025

Presentation

Title

Time / Location

Sunday, October 26

P0302

Implementation of Blood-Based Colorectal Cancer Screening Demonstrates High Adherence: Real-World Clinical Experience

3:30-7:00pm PDT / Exhibit Hall

P1515

Detection of Hepatocellular Carcinoma via Blood-Based Testing in High-Risk Individuals

3:00-3:30pm PDT / Exhibit Hall

Tuesday, October 28

P4744

Assessing Patient Preferences for Blood-Based Lung Cancer and Colorectal Cancer Screening Tests: Insights from a Conjoint Analysis with over 1,700 People in the US

10:30am-4:00pm ET / Exhibit Hall

The full abstracts for Guardant Health and a list of all abstracts being presented at the ACG Annual Meeting can be found here.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

(Press release, Guardant Health, OCT 26, 2025, View Source [SID1234657023])

Initial results from ongoing dose-escalation study of XmAb819 & oncology pipeline update

On October 24, 2025 Xencor presented its corporate presentation.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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(Presentation, Xencor, OCT 24, 2025, View Source [SID1234656985])

Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 24, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported updated preclinical data from the company’s potent and selective pan KRAS(ON) inhibitor in a poster presentation at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place in Boston, MA, October 22-26, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are excited today to share updated data from our pan KRAS(ON) program which demonstrates a potential best-in-class profile for our lead molecule," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We look forward to advancing this program with the goal of filing an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2026."

Poster Details
The poster will be accessible on the ‘Posters and Publications’ page of Cogent’s website.

Title: Identification of CGT1263, a Potent KRAS Inhibitor with Selectivity for Mutant KRAS over HRAS and NRAS
Session Date and Time: Poster Session B, Friday, October 24, 2025 – 12:30 p.m. – 4:00 p.m. ET
Poster Number: B024
Abstract Number: B024

Mutations in KRAS are among the most prevalent mutations found in cancer, occurring most often in colorectal cancer, non-small cell lung cancer and pancreatic cancer. The poster presented today describes Cogent’s internally developed KRAS(ON/OFF) inhibitor CGT1263, showing clear selectivity over HRAS and NRAS, with picomolar (pM) activity across a broad panel of KRAS mutant cell lines. In addition, the poster also characterizes CGT1815 (the prodrug of CGT1263), which is designed to optimize human pharmacokinetic performance, supported by pharmacokinetics data from both CGT1815 and CGT1263 across multiple species. Finally, the poster highlights that CGT1815 demonstrates superior efficacy in KRASG12D and KRASG12V tumor growth inhibition studies when compared to RMC-6236.

(Press release, Cogent Biosciences, OCT 24, 2025, View Source [SID1234656987])