Merck & Co. (MRK) Company Report

The China NMPA granted first-in-world approval of pimicotinib as a systemic treatment for adult patients with symptomatic tenosynovial giant cell tumor.
In the global Phase 3 MANEUVER study, pimicotinib achieved an objective response rate (ORR) of 54% vs 3.2% for placebo at week 25 (p<0.0001).
Pimicotinib was well tolerated with treatment-emergent adverse events leading to discontinuation in 1.6% and dose reductions in 7.9% of patients.
Approval strengthens Merck’s leadership in rare tumors, with additional regulatory filings underway globally.

3 days ago

Press Release

Merck reaches agreement with US government to expand medicine access and lower costs

MRK

New Projects/Investments

Merck and the Trump administration agreed to expand access to prescription medicines and reduce costs for Americans through a historic partnership.
JANUVIA, JANUMET and JANUMET XR will be offered via a direct-to-patient program at a cash price ~70% off current list price for eligible patients.
The program will be expanded post-FDA approval to include enlicitide, a novel oral PCSK9 inhibitor candidate targeting unmet cardiovascular needs.
Merck commits over $70 billion in US capital and R&D investments and secured a three-year delay of Section 232 tariffs to support domestic manufacturing.

5 days ago

Press Release

Merck declines option on Evaxion’s EVX-B2 vaccine candidate

MRK

MSD (Merck & Co.) declined its option for Evaxion’s Gonorrhea vaccine candidate EVX-B2, allowing Evaxion to retain global rights to the program.
Evaxion’s cash runway, extending to the second half of 2027, remains unaffected as the in-licensing decision was not included in its cash-flow outlook.
Earlier in 2025, MSD exercised an option on Evaxion’s EVX-B3 candidate; Evaxion is eligible for up to $592 million in milestone payments plus royalties on net sales.
Evaxion plans to seek a new licensing partner for EVX-B2 and is also developing an mRNA version in collaboration with Afrigen Biologics.

6 days ago

Press Release

Merck & Co. DATROWAY application validated in EU as first-line TNBC therapy

MRK

Product Launch

The EMA has validated the Type II Variation application for DATROWAY® as monotherapy for first-line treatment of unresectable or metastatic triple-negative breast cancer in patients not eligible for PD-1/PD-L1 inhibitors.
This application is supported by TROPION-Breast02 Phase 3 data showing statistically significant and clinically meaningful improvements in overall survival and progression-free survival versus standard chemotherapy.
Approximately 70% of metastatic TNBC patients are not candidates for immunotherapy, positioning DATROWAY as a potential new standard of care pending approval.
Additional regulatory submissions for this indication are underway globally, signaling an expedited development timeline.

7 days ago

Press Release

Adagene announces FDA Fast Track Designation for Muzastotug

MRK

FDA granted Fast Track designation for muzastotug in combination with Merck’s KEYTRUDA for adult patients with microsatellite-stable metastatic colorectal cancer without liver metastases.
Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody engineered for enhanced safety and efficacy to overcome CTLA-4–mediated Treg resistance in tumors.
Fast Track status enables more frequent FDA interactions and may allow rolling review as Adagene advances its randomized Phase 2 and prepares a Phase 3 registration trial planned for 2027.
Phase 2 will enroll up to 30 patients per arm to optimize dosing (10 vs. 20 mg/kg) with overall response rate (ORR) as the primary endpoint; Phase 3 will focus on overall survival (OS) against a standard-of-care control.

Dec 16, 2025, 12:00 PM

Press Release

Merck & Co. announces five-year outcomes from IO Biotech melanoma vaccine trial

MRK

25.5-month median progression-free survival observed in the five-year follow-up of the MM1636 Phase 1/2 trial evaluating IO102-IO103 plus nivolumab in first-line metastatic melanoma
Durable responses with a median duration of >53 months and a median overall survival of 60 months
Results supported FDA Breakthrough Therapy Designation for IO102-IO103 in combination with Merck’s pembrolizumab (KEYTRUDA) in unresectable/metastatic melanoma
Data provided the rationale for initiating the pivotal Phase 3 IOB-013/KN-D18 trial in first-line advanced melanoma

Dec 15, 2025, 9:05 PM

Press Release

Merck receives positive EU CHMP opinion for expanded WINREVAIR use in PAH

MRK

Product Launch

The EMA’s CHMP recommended approval of an expanded indication for WINREVAIR (sotatercept) in adults with PAH (WHO FC II–IV), extending beyond the current FC II–III approval in the EU.
The recommendation is based on Phase 3 ZENITH data showing a 76% reduction in the risk of major morbidity and mortality (HR: 0.24; 95% CI: 0.13–0.43; p<0.0001) in WHO FC III–IV patients, leading to early trial termination for overwhelming efficacy.
The CHMP opinion now goes to the European Commission, with a final decision expected in Q1 2026.

Dec 12, 2025, 1:45 PM

Press Release

Merck & Co. positions telomere-targeting agent for NSCLC in $50B immunotherapy market

MRK

Product Launch

New Projects/Investments

The global checkpoint inhibitor market generated $50 billion in 2024, with NSCLC accounting for over 30% of NSCLC drug sales; Keytruda alone reported $29.5 billion in revenue in 2024, of which NSCLC represented an estimated 30%.
MAIA’s ateganosine is the first-in-class telomere-targeting agent designed to exploit telomerase activity in over 80% of tumors, awarded Fast Track Designation by the FDA for NSCLC patients resistant to immunotherapy and chemotherapy, and is now in the Phase 3 THIO-104 trial.
The NSCLC market is valued at $34.1 billion and is projected to reach $68.8 billion by 2033, with roughly 180,000 new NSCLC patients entering treatment annually in the US.
Ateganosine holds Orphan Drug Designations for glioblastoma, hepatocellular carcinoma, and small cell lung cancer, each providing seven years of US market exclusivity and access to tax credits upon approval.

Dec 10, 2025, 7:00 PM

Press Release

Medicenna presents MDNA11 efficacy and safety data at ESMO-IO 2025

MRK

MDNA11 monotherapy in ICI-resistant patients achieved an ORR of 42% (5/12) and DCR of 83%, with response rates of 38% in melanoma and 22% in MSI-H tumors.
Combination of MDNA11 with KEYTRUDA delivered an ORR of 50% and DCR of 75% in MSS endometrial cancer, and an ORR of 25% with DCR of 88% in TMB-H tumors.
The treatment showed a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1–2 and no dose-limiting toxicities observed at doses up to 120 µg/kg.
Patients achieving disease control experienced significantly improved overall survival: monotherapy mOS of 120.2 weeks vs 28.6 weeks, and combination mOS not yet reached vs 26 weeks in non-responders.

Dec 10, 2025, 12:30 PM

Press Release

Merck & Co. presents Lisaftoclax combination data at ASH 2025

MRK

Preliminary Phase Ib/II data of Lisaftoclax plus azacitidine demonstrated 31.8% ORR in venetoclax-resistant myeloid malignancies and 80% ORR in newly diagnosed high-risk MDS/CMML (N=103).
In relapsed/refractory AML/MPAL (N=44), ORR was 43.2% with a CR rate of 31.8%; among venetoclax-exposed R/R AML/MPAL (N=22), ORR was 31.8% with CR 22.7%.
Median overall survival was 7.6 months in R/R AML/MPAL, 11.3 months in R/R HR MDS/CMML, 6.3 months in newly diagnosed AML/MPAL, and not reached in ND HR MDS/CMML.
Safety profile was favorable with no dose-limiting toxicities; common grade ≥3 events included neutropenia (41.7%) and febrile neutropenia (35.0%).

Dec 8, 2025, 1:10 AM

Press Release

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Merck & Co. (MRK)

Analyst Earnings Quarterly Reports

Q3 2025

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Executives

Robert M. Davis

Betty Larson

Caroline Litchfield

Dean Li

Richard R. DeLuca, Jr.

Board Members

Christine E. Seidman, M.D.

Douglas M. Baker, Jr.

Inge G. Thulin

Kathy J. Warden

Mary Ellen Coe

Pamela J. Craig

Patricia F. Russo

Paul B. Rothman, M.D.

Risa J. Lavizzo-Mourey, M.D.

Stephen L. Mayo, Ph.D.

Surendralal L. Karsanbhai

Thomas H. Glocer

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Mohit Bansal

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Vamil Divan

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James Shin

Terence Flynn

Trung Huynh

Alexandria Hammond

Courtney Breen

Asad Haider

Evan Seigerman

Geoffrey Meacham

Luisa Hector

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Timothy Anderson

Carter L. Gould

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