Molecular Partners Reports Q3 2025 Financial Results and Clinical Progress, with DLL3-Targeting Radio-DARPin MP0712 Phase 1 Launch Expected in 2025

On October 30, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the third quarter of 2025.

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"We are excited to present initial clinical imaging data this November on MP0712, the 1st Radio-DARPin targeting DLL3, from compassionate care use in South Africa. The IND application for MP0712 has been filed and we see the alpha-targeting approaches for DLL3 in lung cancer as a valuable new modality for patients. Building on that progress, we are establishing a pipeline of additional Radio-DARPins with our partner Orano Med for selected targets, including mesothelin for ovarian cancer," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "MP0533 is the first-ever tetraspecific T-cell engager to demonstrate safety and efficacy in AML. We will report additional data on optimized dosing and a deeper understanding on the ideal patient profile for MP0533. This understanding is important to plan next steps and is supportive of positioning of our drug in the treatment landscape."

Research & Development Highlights

MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Collaboration with Orano Med

The Phase 1 Investigational New Drug (IND) application for MP0712, a 212Pb-based Radio-DARPin therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3), co-developed with Orano Med for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed. Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate before the end of 2025.

Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing high tumor uptake, promising efficacy and a favorable safety profile for MP0712 in mouse models matching clinically-relevant DLL3 expression levels.

In H1 2025, Molecular Partners accepted a request from the Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of initial images applying MP0712 labeled with 203Pb in patients with SCLC and other DLL3-expressing neuroendocrine cancers. As per courtesy of NuMeRI, the Company will present first images from the MP0712 compassionate care program at the Targeted Radiopharmaceuticals (TRP) Summit EU in November. The NuMeRI team, lead by Dr. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Conference (TWC) in January 2026.
203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb primarily used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb provides a prediction of treatment behavior with 212Pb.

In January 2025, Molecular Partners and Orano Med expanded their agreement to co-develop up to ten radiotherapy programs. In addition to its world class expertise and capabilities in the development of TAT with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Orano Med possesses virtually unlimited source material for 212Pb production and has established robust and independent supply and manufacturing capabilities required for the seamless delivery of TAT to clinical sites internationally.

The second RDT program slated for clinical development is MP0726, targeting mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN, which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several programs in 2026, including MP0726.

MP0533 (Multispecific T Cell Engager; CD33 x CD123 x CD70 x CD3)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)/AML (NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, with promising antitumor activity observed in cohort 8. Three of 8 (>30%) evaluable patients in this cohort achieved a clinical response after the first cycle, and two patients maintained their responses for over three months, including one patient still on treatment today (>12 months response duration). Cohort 8 benefited from a higher starting dose and a faster step-up dosing schedule, leading to improved exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustment.

Encouraged by these results, Molecular Partners amended the dosing scheme for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication to achieve higher cumulative exposure as well as enhanced depth and duration of responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing in the first 14 days of treatment. Data from cohort 9 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. Cohort 10, which aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time, is now enrolling and dosing patients.

MP0533 continues to show broad activity in a mutation-agnostic manner, with initial blast reductions in a majority of patients treated, and an acceptable safety profile. The data continue to indicate that the patients more likely to see durable responses will be those who initiate therapy with a lower level of blasts at baseline. Molecular Partners plans to explore MP0533 in combination settings, both in patients with relapsed/refractory disease as well as in front-line setting, should favorable antitumor activity continue to be observed. Several consortia have approached Molecular Partners expressing interest in conducting such studies. The Company is engaging with key opinion leaders and regulators to discuss next steps.

MP0317 (Tumor-Localized Agonist; FAP x CD40)

Molecular Partners is supporting an investigator-initiated trial of MP0317, for which a study protocol has been approved (NCT07036380). This proof-of-concept randomized Phase 2 study, to be conducted by an expert network in France, is designed for the treatment of patients with advanced cholangiocarcinoma in combination with anti-PD-L1 therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy. The main objective of the study is to assess the 12-month progression free survival (PFS) in the experimental arm (N = 50 patients).

MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies. Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2024.

Switch-DARPins (Next-Generation Immune Cell Engagers)

By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept for a novel CD3 Switch-DARPin TCE with CD2 costimulation was presented at AACR (Free AACR Whitepaper) in April 2025. The data show the feasibility of conditional T cell activation with potent co-stimulation in solid tumors, but not in healthy tissues. In addition, data showed that the CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing the tumor targets MSLN and EpCAM, thereby increasing tumor specificity. The Company will present an update on the CD3 Switch-DARPin program at SITC (Free SITC Whitepaper) in November 2025.

Corporate Governance Highlights

Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. Martin brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.

(Press release, Molecular Partners, OCT 30, 2025, View Source [SID1234657157])

Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results

On October 30, 2025 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the third quarter of 2025.

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"In the third quarter, we continued to execute on our strategy with important pipeline advancements, significant approvals and successful new product launches," said Robert M. Davis, chairman and chief executive officer. "We’re delivering value to patients and customers through our innovative portfolio of medicines and vaccines, and we’re securing our future by making important investments in our pipeline – including through compelling, strategic business development like our completed acquisition of Verona Pharma and expanded U.S. manufacturing and R&D spending. With each milestone we achieve, my conviction that we’re well-positioned to drive the next chapter of success for our Company increases."

Financial Summary

Third Quarter

$ in millions, except EPS amounts

2025

2024

Change

Change Ex-Exchange

Sales

$17,276

$16,657

4%

3%

GAAP net income1

5,785

3,157

83%

84%

Non-GAAP net income that excludes certain items1,2*

6,448

3,985

62%

62%

GAAP EPS

2.32

1.24

87%

88%

Non-GAAP EPS that excludes certain items2*

2.58

1.57

64%

65%

*Refer to table on page 7.

For the third quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.32 and non-GAAP EPS was $2.58. GAAP and non-GAAP EPS in the third quarter of 2025 include a charge of $0.10 per share for a milestone payment to LaNova Medicines Ltd. (LaNova, acquired by Sino Biopharmaceutical Limited) associated with the technology transfer for MK-2010. GAAP and non-GAAP EPS in the third quarter of 2024 include a net charge of $0.79 per share in the aggregate for the acquisition of Eyebiotech Limited (EyeBio) and a related development milestone, the acquisition of MK-1045 from Curon Biopharmaceutical (Curon), as well as a payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement to include gocatamig (MK-6070).

Non-GAAP EPS in both periods excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the third quarter of 2025 also excludes tax expense relating to audit reserve adjustments.

Year-to-date results can be found in the attached tables.

Third-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.

Third Quarter

$ in millions

2025

2024

Change

Change Ex-Exchange

Commentary

Total Sales

$17,276

$16,657

4%

3%

Pharmaceutical

15,611

14,943

4%

3%

Increase primarily driven by growth in oncology, cardiovascular and diabetes, partially offset by declines in vaccines, virology and immunology.

KEYTRUDA

8,142

7,429

10%

8%

Growth driven by continued strong global demand from metastatic indications, including urothelial, endometrial and gastric cancers, as well as robust global uptake in earlier-stage indications including triple-negative breast cancer, cervical cancer, renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Sales also benefitted from timing of wholesaler purchases in the U.S., partially offset by other channel movements.

GARDASIL/GARDASIL 9

1,749

2,306

-24%

-25%

Decline primarily due to lower demand in China. Excluding China, sales declined 2%, or 3% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, partially offset by higher sales in the U.S. due to higher net pricing and favorable public-sector purchasing patterns.

PROQUAD, M-M-R II and VARIVAX

684

703

-3%

-3%

Decline primarily due to lower demand, partially offset by higher net pricing in the U.S.

JANUVIA/JANUMET

624

482

29%

29%

Growth driven by higher net pricing in the U.S., partially offset by lower demand in China as well as in most other international markets due to generic competition.

BRIDION

439

420

5%

4%

Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.

Lynparza*

379

337

12%

12%

Growth primarily due to higher demand in the U.S. and certain international markets.

WINREVAIR

360

149

141%

141%

Growth largely reflects continued uptake in the U.S., partially offset by timing of distributor purchases and lower net pricing in the U.S. largely due to Medicare Part D redesign.

PREVYMIS

266

208

28%

25%

Increase primarily due to higher demand in the U.S. and launch of new indications in certain international markets, partially offset by lower demand in China due to generic competition.

Lenvima*

258

251

3%

2%

Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower net pricing.

CAPVAXIVE

244

47

N/M

N/M

Represents continued uptake since third-quarter 2024 launch in the U.S., as well as expected seasonal inventory build.

VAXNEUVANCE

226

239

-6%

-7%

Decline primarily due to lower demand in certain international markets, particularly in Japan due to competitive pressure, partially offset by higher demand in certain European markets.

WELIREG

196

139

42%

41%

Growth primarily driven by higher demand in the U.S. and continued launch uptake in certain European markets, partially offset by lower net pricing in the U.S.

LAGEVRIO

138

383

-64%

-65%

Decline primarily due to lower demand in the Asia Pacific region, particularly in Japan, as well as in the U.S.

SIMPONI

189

-100%

-100%

Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.

Animal Health

1,615

1,487

9%

7%

Growth primarily due to performance of livestock products.

Livestock

1,023

886

16%

14%

Growth primarily driven by higher demand across all species, as well as timing of sales.

Companion Animal

592

601

-2%

-3%

Decline primarily due to lower demand, reflecting a reduction in veterinary visits and competitive pressure for parasiticides, partially offset by higher pricing, improved supply and new product launches. Sales of BRAVECTO were $262 million and $266 million in current and prior-year quarters, respectively, which represents a decline of 1%, or 3% excluding impact of foreign exchange.

Other Revenues**

50

227

-78%

-27%

Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements.

*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

N/M- Not meaningful.

In addition, Koselugo alliance revenue was $214 million in the third quarter of 2025 compared with $39 million in the third quarter of 2024. The increase was due to an amendment to the collaboration agreement with AstraZeneca, which discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure, resulting in the Company’s recognition of a $150 million upfront payment and a $50 million regulatory milestone.

Third-Quarter Expense, EPS and Related Information
The table below presents selected expense information.

$ in millions

GAAP

Acquisition-

and

Divestiture-

Related

Costs3

Restructuring

Costs

(Income)

Loss From

Investments

in Equity

Securities

Non-GAAP2

Third Quarter 2025

Cost of sales

$3,855

$621

$110

$-

$3,124

Selling, general and administrative

2,633

34

2,599

Research and development

4,234

4

233

3,997

Restructuring costs

47

47

Other (income) expense, net

(238)

(344)

106

Third Quarter 2024

Cost of sales

$4,080

$639

$192

$-

$3,249

Selling, general and administrative

2,731

43

31

2,657

Research and development

5,862

24

5,838

Restructuring costs

56

56

Other (income) expense, net

(162)

(27)

58

(193)

GAAP Expense, EPS and Related Information
Gross margin was 77.7% for the third quarter of 2025 compared with 75.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix and lower restructuring costs, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange.

Selling, general and administrative (SG&A) expenses were $2.6 billion in the third quarter of 2025, a decrease of 4% compared with the third quarter of 2024. The decrease was primarily due to lower administrative, restructuring and selling costs, partially offset by the unfavorable impact of foreign exchange.

Research and development (R&D) expenses were $4.2 billion in the third quarter of 2025, a decrease of 28% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher restructuring costs and clinical development spending.

Other (income) expense, net, was $238 million of income in the third quarter of 2025 compared with $162 million of income in the third quarter of 2024. The favorability was primarily due to net income from investments in equity securities in 2025 compared with net losses from investments in equity securities in 2024, partially offset by $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070).

The effective tax rate was 14.2% for the third quarter of 2025.

GAAP EPS was $2.32 for the third quarter of 2025 compared with $1.24 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment.

Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.9% for the third quarter of 2025 compared with 80.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange.

Non-GAAP SG&A expenses were $2.6 billion in the third quarter of 2025, a decrease of 2% compared with the third quarter of 2024. The decrease was primarily due to lower administrative and selling costs, partially offset by the unfavorable impact of foreign exchange.

Non-GAAP R&D expenses were $4.0 billion in the third quarter of 2025, a decrease of 32% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher clinical development spending.

Non-GAAP other (income) expense, net, was $106 million of expense in the third quarter of 2025 compared with $193 million of income in the third quarter of 2024. The unfavorability was primarily due to $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070).

The non-GAAP effective tax rate was 13.4% for the third quarter of 2025.

Non-GAAP EPS was $2.58 for the third quarter of 2025 compared with $1.57 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

Third Quarter

$ in millions, except EPS amounts

2025

2024

EPS

GAAP EPS

$2.32

$1.24

Difference

0.26

0.33

Non-GAAP EPS that excludes items listed below2

$2.58

$1.57

Net Income

GAAP net income1

$5,785

$3,157

Difference

663

828

Non-GAAP net income that excludes items listed below1,2

$6,448

$3,985

Excluded Items:

Acquisition- and divestiture-related costs3

$659

$679

Restructuring costs

390

279

(Income) loss from investments in equity securities

(344)

58

Decrease to net income before taxes

705

1,016

Estimated income tax (benefit) expense4

(42)

(188)

Decrease to net income

$663

$828

Pipeline and Portfolio Highlights
In the third quarter, the Company continued to demonstrate pipeline progress with the achievement of key regulatory and clinical milestones.

In oncology, in September 2025, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA QLEX injection for subcutaneous (SC) administration for use in adults across most solid tumor indications for KEYTRUDA, based on results from the Phase 3 MK-3475A-D77 trial. In October 2025, the FDA subsequently approved KEYTRUDA QLEX for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. KEYTRUDA QLEX is now approved for use in adults across all solid tumor indications approved for KEYTRUDA and is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute.

In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval for SC administration of KEYTRUDA for all adult indications; a final decision is expected in the fourth quarter of 2025. The European Commission (EC) also approved KEYTRUDA as part of a perioperative regimen for the treatment of PD-L1+ resectable LA-HNSCC.

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, the Company announced new research from its broad and differentiated portfolio and pipeline, highlighting progress in new tumor types and earlier stages of disease. This included positive results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC), the Phase 3 KEYNOTE-B96 trial in platinum-resistant recurrent ovarian cancer and the Phase 2/3 REJOICE-Ovarian01 trial in collaboration with Daiichi Sankyo in certain types of platinum-resistant ovarian cancer, long-term follow-up data from the Phase 3 KEYNOTE-775 trial in advanced endometrial cancer, as well as long-term data for KEYTRUDA in both earlier-stage and metastatic NSCLC.

In vaccines and infectious diseases, in August 2025, the Company received two approvals in Japan: its nine-valent HPV vaccine for use in males ages 9 and older that will be marketed under the trademark SILGARD 9, and CAPVAXIVE for use in the elderly or adults who are at an increased risk of pneumococcal disease.

At the European AIDS Clinical Society 2025 conference, the Company also presented new data from Phase 3 trials evaluating the once-daily, oral, two-drug regimen of doravirine/islatravir in adults with virologically suppressed HIV-1 infection, which showed minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance across both clinical trials.

In cardiovascular disease, the Company announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia. The trial met all primary and key secondary endpoints. Enlicitide has the potential to be the first approved oral PCSK9 inhibitor.

In addition, the FDA approved an update to the U.S. product label for WINREVAIR, based on results from the Phase 3 ZENITH trial, expanding the indication to include components of the clinical worsening events: hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death. Further, at the 2025 European Respiratory Society Congress, the Company presented positive results from the Phase 3 HYPERION trial evaluating WINREVAIR versus placebo (both in combination with background therapy) in adults recently diagnosed with PAH (Group 1 pulmonary hypertension) with World Health Organization (WHO) functional class II or III at intermediate or high risk of disease progression. Results showed that adding WINREVAIR within the first year after PAH diagnosis significantly reduced the risk of clinical worsening events compared to placebo.

The Company also completed its acquisition of Verona Pharma plc (Verona Pharma) in October 2025, strengthening its cardio-pulmonary portfolio with the addition of OHTUVAYRE, an FDA-approved, first-in-class maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients.

Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*

Oncology

FDA Approved KEYTRUDA QLEX Injection for SC Use in Adults Across Most Solid Tumor Indications for KEYTRUDA; Based on Results From Phase 3 MK-3475A-D77 Trial

FDA Granted Breakthrough Therapy Designation for Raludotatug Deruxtecan (R-DXd) for Patients With CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated With Bevacizumab; Based on Results From Phase 1 Trial and REJOICE-Ovarian01 Phase 2/3 Trial

FDA Granted Breakthrough Therapy Designation for Ifinatamab Deruxtecan (I-DXd) for Patients With Pretreated Extensive-Stage Small Cell Lung Cancer; Based on Results From Phase 2 IDeate-Lung01 Trial

FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each in Combination With Padcev, for Certain Patients With MIBC; FDA Set Prescription Drug User Fee Act (PDUFA) Date of April 7, 2026

EC Approved KEYTRUDA as Part of a Treatment Regimen for Adults With Resectable LA-HNSCC Expressing PD-L1 (CPS≥1); Based on Results From Phase 3 KEYNOTE-689 Trial

EU CHMP Adopted Two Positive Opinions for KEYTRUDA, for SC Administration and for New Indication for Earlier-Stage Head and Neck Cancer; Latter Based on Results From Phase 3 KEYNOTE-689 Trial

KEYTRUDA Plus Padcev Reduced Risk of Event-Free Survival Events by 60% and Risk of Death by 50% for Certain Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-905 Trial

KEYTRUDA Plus Chemotherapy, With or Without Bevacizumab, Reduced Risk of Disease Progression or Death Versus Chemotherapy, With or Without Bevacizumab, in Certain Patients With Platinum-Resistant Recurrent Ovarian Cancer; Based on Results From Phase 3 KEYNOTE-B96 Trial; FDA Set PDUFA Date of Feb. 20, 2026

Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer

R-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Recurrent Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer in Phase 2 Part of REJOICE-Ovarian01 Phase 2/3 Trial

KEYTRUDA Demonstrated Long-Term Survival Benefit in Certain Patients With Earlier or Advanced Stages of NSCLC; Based on Exploratory Five-Year Analyses of Phase 3 KEYNOTE-671 Trial, Eight-Year Analyses of Phase 3 KEYNOTE-024 and KEYNOTE-042 Trials, and 10-Year Analyses of Phase 1b KEYNOTE-001 and Phase 2/3 KEYNOTE-010 Trials

KEYTRUDA Plus Lenvima Demonstrated Durable Five-Year Survival Benefit Versus Chemotherapy for Patients With Advanced Endometrial Carcinoma Following One Prior Platinum-Based Regimen; Based on Results From Phase 3 KEYNOTE-775 Trial

WELIREG Plus Lenvima Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced RCC; Based on Results From Phase 3 LITESPARK-011 Trial

KEYTRUDA Plus WELIREG Met Primary Endpoint of Disease-Free Survival in Certain Patients With Clear Cell RCC Following Nephrectomy; Based on Results From Phase 3 LITESPARK-022 Trial

I-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial

HERTHENA-Breast04 Phase 3 Trial of Patritumab Deruxtecan (HER3-DXd) Initiated in Patients With Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Previously Treated With Endocrine Therapy

Vaccines and Infectious Diseases

CAPVAXIVE Demonstrated Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial

The Company Announced New Data From Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir in Adults With Suppressed HIV-1 Infection; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials

Systematic Review of 15 Studies Focused on Epidemiology and Antimicrobial Resistance of Pneumococcal Serotypes Covered by CAPVAXIVE in U.S. Adults

Cardiovascular

FDA Approved Updated Indication for WINREVAIR in Adults With PAH Based on Phase 3 ZENITH Study

WINREVAIR Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial

Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults With Hypercholesterolemia in Pivotal Phase 3 CORALreef Lipids Study

Immunology

The Company Expanded Tulisokibart Clinical Development Program With Initiation of Phase 2b Trials in Three Additional Immune-Mediated Inflammatory Diseases

*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement.

Manufacturing and R&D Investment
The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities and broke ground on a new $3 billion Center of Excellence for Pharmaceutical Manufacturing at its Elkton, Virginia site. The 400,000-square-foot facility will include both active pharmaceutical ingredient and drug product investment to support small molecule manufacturing and testing, creating more than 500 full-time jobs. This investment is part of the Company’s commitment to dedicate more than $70 billion beginning in 2025 to expand domestic manufacturing and R&D — not including any future business development in R&D — to drive its long-term growth and strengthen the U.S. as a global leader in biopharmaceutical innovation.

Upcoming Investor Event
The Company also plans to present new data from its innovative cardiovascular pipeline and portfolio at the American Heart Association (AHA) Scientific Sessions 2025 from Nov. 7-10. The Company will host an Investor Event to coincide with the AHA Scientific Sessions 2025 on Sunday, Nov. 9 at 6 p.m. CT. The event will take place in New Orleans and will be accessible via live audio webcast at this weblink.

Sustainability Highlights
The Company’s 2024/2025 Purpose for Progress Impact Report provided a comprehensive view of how it is pursuing innovative science for the health of people and animals and ensuring its efforts drive significant and sustainable value. The report noted that the Company’s medicines and vaccines reached more than 450 million people around the world in 2024.

Full-Year 2025 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.

Full Year 2025

Updated

Prior

Sales*

$64.5 billion to $65.0 billion

$64.3 billion to $65.3 billion

Non-GAAP Gross margin2

Approximately 82%

Approximately 82%

Non-GAAP Operating expenses2(a)

$25.9 billion to $26.4 billion

$25.6 billion to $26.4 billion

Non-GAAP Other (income) expenses, net2

$400 million to $500 million expense

$300 million to $400 million expense

Non-GAAP Effective tax rate2

14.0% to 15.0%

15.0% to 16.0%

Non-GAAP EPS2(b)(c)

$8.93 to $8.98

$8.87 to $8.97

Share count (assuming dilution)

Approximately 2.51 billion

Approximately 2.51 billion

*The Company does not have any non-GAAP adjustments to sales.

(a)Includes one-time R&D charges of $300 million for a milestone payment to LaNova associated with the technology transfer for MK-2010 and $200 million for an upfront payment for a license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma). Outlook does not assume any additional significant potential business development transactions.

(b)Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and the upfront payment to Hengrui Pharma.

(c)Updated full-year 2025 outlook reflects a benefit of approximately $0.09 per share resulting from an amendment to the collaboration agreement with AstraZeneca related to Koselugo, and an estimated negative impact of $0.04 per share related to the acquisition of Verona Pharma.

The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.

The Company now expects full-year 2025 sales to be between $64.5 billion and $65.0 billion, including a negative impact of foreign exchange of approximately 0.5% at mid-October 2025 exchange rates.

The Company now expects its full-year non-GAAP effective income tax rate to be between 14.0% and 15.0%.

The Company now expects its full-year non-GAAP EPS to be between $8.93 and $8.98, including a negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS outlook reflects several items not previously included, such as a benefit from an amended collaboration agreement with AstraZeneca related to Koselugo, and operational improvements, including a more favorable estimated tax rate and lower estimated costs related to the impact of tariffs, partially offset by an estimated negative impact related to the acquisition of Verona Pharma and an incremental negative impact from foreign exchange. The midpoint of this revised non-GAAP EPS range reflects a net improvement of $0.04 per share compared to the midpoint of the Company’s prior outlook.

As previously communicated, the revised estimated full-year 2025 non-GAAP EPS range reflects the impacts of the one-time charges in connection with a license agreement with Hengrui Pharma and the completion of the technology transfer with LaNova for MK-2010, which impact EPS by approximately $0.16 in the aggregate. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations.

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Thursday, Oct. 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

(Press release, Merck & Co, OCT 30, 2025, View Source [SID1234657156])

Boehringer Ingelheim acquires license from Kyowa Kirin aimed at developing a novel treatment for patients with autoimmune diseases

On October 30, 2025 Boehringer Ingelheim and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and COO: Abdul Mullick) reported that Boehringer Ingelheim has licensed a pre-clinical program from Kyowa Kirin to develop a potential first-in-class, small molecule for the treatment of autoimmune diseases.

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Autoimmune diseases represent a substantial and growing global health challenge, affecting approximately one in ten people and imposing a significant burden on patients and healthcare systems. Despite progress in therapeutic innovation, there remains a high need for more effective and long-lasting treatment options. As a recognized leader in autoimmune disease research and development, Boehringer Ingelheim advances new approaches that target the root causes of autoimmune conditions, with the goal of delivering highly targeted new therapies.

"Our commitment to delivering life changing therapies for patients with autoimmune diseases is unwavering. We are pleased to add a potential first in class program to our growing pipeline," said Carine Boustany, US Innovation Unit Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. "This agreement constitutes an important step toward delivering breakthrough treatments for patients ."

Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin, commented, "This compound, discovered through Kyowa Kirin’s deep expertise in innovative technology and disease biology, holds tremendous potential. Leveraging Boehringer Ingelheim’s renowned expertise in inflammatory diseases, we are confident that this innovation will be developed efficiently and delivered to the patients who need it most."

Under the terms of the agreement Boehringer Ingelheim will receive exclusive worldwide rights from Kyowa Kirin to develop this small molecule program. Kyowa Kirin is eligible to receive up to € 640 million, including an upfront payment, success-based development, regulatory, and commercial milestone payments, in addition to royalties on possible sales.

(Press release, Kyowa Hakko Kirin, OCT 30, 2025, View Source [SID1234657155])

Jecho Laboratories, Inc. Announces Late-Breaking Abstract Selected for Poster Presentation at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting

On October 30, 2025 Jecho Laboratories, Inc. reported it will present emerging clinical data from a Phase 1 study of JL18008, an innovative IL-7/HSA fusion protein for HIV immunological non-responders and lymphocytopenia, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting.

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The SITC (Free SITC Whitepaper) meeting will be held November 5 – 9, 2025 in National Harbor, Maryland.

Details on the presentation are below:

Abstract 1339: A randomized, double-blind, placebo-controlled, dose-escalated, first-in-human study to assess the safety, tolerability, and T cell replenishment of JL18008, a long-acting IL-7, in healthy subjects

Abstract Presentation Number: 1339
Session Time: Friday, November 7, 2025 viewing 10 a.m. – 7 p.m. EST
Location: Gaylord National Resort & Convention Center – Exhibit Halls AB

(Press release, Jecho Laboratories, OCT 30, 2025, View Source [SID1234657154])

Insmed Reports Third-Quarter 2025 Financial Results and Provides Business Update

On October 30, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the third quarter ended September 30, 2025 and provided a business update.

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"The third quarter of 2025 celebrated the FDA approval of BRINSUPRI and the availability of our second commercial product, underscoring our team’s dedication to bringing forward a first-in-disease therapy for patients with non-cystic fibrosis bronchiectasis. While still early in the U.S. BRINSUPRI launch, we are very encouraged by positive feedback received from both physicians and patients," said Will Lewis, Chair and Chief Executive Officer of Insmed. "This achievement is just the beginning of numerous commercial and clinical catalysts anticipated over the next 18 months across our late-stage programs – ARIKAYCE, brensocatib, and TPIP – and our growing clinical pipeline of first- or best-in-class therapies. With these opportunities ahead, our team is more dedicated than ever to transforming the lives of patients with serious diseases."

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE


ARIKAYCE global revenue grew 22% in the third quarter of 2025 compared to the third quarter of 2024, reflecting year-over-year growth across all geographic regions.


The Company anticipates the topline readout of the Phase 3 ENCORE trial in the first half of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.


Assuming successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

Brensocatib


In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S.


In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of BRINSUPRI (brensocatib 25mg tablets) for the treatment of NCFB in the European Union (EU).


Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory.


Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026.


In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed now expects to report topline data from CEDAR in the first half of 2026.

TPIP


Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.


Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.


The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

Gene Therapy


Insmed completed dosing of the first cohort in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).


The Company’s Investigational New Drug (IND) filing for INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic lateral sclerosis (ALS), has been cleared by the FDA.


Insmed’s third gene therapy candidate targeting Stargardt disease is currently advancing toward the clinic, with an IND filing expected in the first half of 2026.

Pre-Clinical Programs


Insmed’s research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.


The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.


Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

Corporate Updates


In September 2025, Insmed presented seven abstracts from across its portfolio at the European Respiratory Society (ERS) Congress 2025.


In October 2025, Insmed presented six abstracts from across its portfolio at the American College of Chest Physicians (CHEST) 2025 Annual Meeting.


In October 2025, Insmed announced that it has earned the No. 1 ranking in Science’s 2025 Top Employers Survey, marking the fifth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.

Third-Quarter 2025 Financial Results

The following table summarizes Insmed’s third-quarter and year-to-date 2025 and 2024 revenues and revenue growth across all commercial regions:


Three Months Ended
September 30,

Nine Months Ended
September 30,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
74.0

$
66.9

11
%

$
206.9

$
187.0

11
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
114.3

$
93.4

22
%

$
314.5

$
259.3

21
%
BRINSUPRI

U.S.

$
28.1

$


N/A

$
28.1

$


N/A

International





N/A





N/A

Total

$
28.1

$


N/A

$
28.1

$


N/A

Total Revenues

U.S.

$
102.0

$
66.9

53
%

$
235.0

$
187.0

26
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
142.3

$
93.4

52
%

$
342.6

$
259.3

32
%


Cost of product revenues (excluding amortization of intangibles) was $29.4 million for the third quarter of 2025, compared to $21.2 million for the third quarter of 2024. The increase in cost of product revenues primarily reflects growth in ARIKAYCE sales and BRINSUPRI sales.


Research and development (R&D) expenses were $186.4 million for the third quarter of 2025, compared to $150.8 million for the third quarter of 2024. The increase in R&D expenses was primarily related to increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as clinical development and research costs, and manufacturing costs.


Selling, general and administrative (SG&A) expenses for the third quarter of 2025 were $186.4 million, compared to $118.9 million for the third quarter of 2024. The increase in SG&A expenses was primarily related to increases in professional fees and other external expenses, as well as increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial readiness and commercial activities for BRINSUPRI.


For the third quarter of 2025, Insmed reported a net loss of $370.0 million, or $1.75 per share, compared to a net loss of $220.5 million, or $1.27 per share, for the third quarter of 2024.

Balance Sheet, Financial Guidance, and Planned Investments


As of September 30, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion.


Insmed is raising its full-year 2025 global ARIKAYCE revenue guidance to a range of $420 million to $430 million, from a range of $405 million to $425 million previously, representing a range of 15% to 18% year-over-year growth compared to 2024.


The Company plans to continue to invest in the following key activities in 2025:

(i)
commercialization and expansion of BRINSUPRI in the U.S., with advancement of regulatory submissions for brensocatib in Europe, the UK, and Japan;

(ii)
commercialization and expansion of ARIKAYCE globally;

(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;

(iv)
advancement of the Phase 3 ENCORE study for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung disease;

(v)
advancement of clinical development programs for TPIP, including the initiation of a Phase 3 study in patients with PH-ILD and preparations for separate Phase 3 studies in patients with PAH, PPF, and IPF;

(vi)
advancement of the Phase 1 ASCEND study for INS1201 in DMD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, October 30, 2025, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 6, 2025, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, OCT 30, 2025, View Source [SID1234657153])