Merck & Co. (MRK) Company Report

China’s NMPA has cleared Promega’s OncoMate® MSI Detection Kit as a Class III in vitro companion diagnostic for KEYTRUDA®, marking Promega’s first NMPA-approved companion test in China.
The PCR-based assay detects high microsatellite instability (MSI-H) in solid tumors to inform anti-PD-1 therapy decisions with KEYTRUDA®.
Approval follows a collaboration with Merck & Co., reflecting joint efforts to expand precision-oncology diagnostics in China.
The kit, also recently authorized by the FDA and in the EU, is slated to launch in China soon.

10 hours ago

Press Release

Merck expands IVF medication access for U.S. patients

MRK

EMD Serono’s full portfolio of fertility drugs—Gonal-f®, Ovidrel® and Cetrotide®—is now accessible via TrumpRx.gov and FertilityInstantSavings.com.
New pathways simplify out-of-pocket access to IVF therapies, aligning with the Executive Order “Expanding Access to In Vitro Fertilization”.
Received an FDA Commissioner’s National Priority Voucher for Pergoveris® (follitropin alfa/lutropin alfa), expediting its U.S. review for ovarian stimulation candidates.
EMD Serono’s innovations have contributed to over 6 million successful IVF births globally.

12 hours ago

Press Release

Merck & Co. secures NMPA approval for Promega MSI companion diagnostic for KEYTRUDA

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Product Launch

China's NMPA approved Promega OncoMate® MSI Dx kit as a companion diagnostic for KEYTRUDA® (pembrolizumab).
OncoMate® employs PCR-based technology to detect MSI-H tumors and identify patients eligible for pembrolizumab therapy.
This approval reflects the collaboration between Merck & Co. and Promega to advance personalized oncology treatments in China.
OncoMate® MSI Dx has also received FDA approval in the U.S. to guide LENVIMA® combination therapy in select cancer patients.

2 days ago

Press Release

Merck & Co. gains NMPA approval for Promega MSI kit as KEYTRUDA companion diagnostic

MRK

Product Launch

China’s NMPA approves Promega OncoMate® MSI detection kit as the first companion diagnostic for KEYTRUDA in China.
The PCR-based assay detects MSI-High status in solid tumors to guide PD-1 therapy decisions.
Approval achieved through collaboration between Promega and Merck & Co., expanding companion diagnostic tools for KEYTRUDA.
OncoMate® MSI kit will launch in China, complementing earlier FDA and EU clearances.

2 days ago

Press Release

Merck & Co. MSI Detection Kit approved as KEYTRUDA® companion diagnostic in China

MRK

Product Launch

Chinese NMPA approves Promega’s OncoMate® MSI Detection Kit as a Class III in vitro diagnostic device in China.
Enables identification of patients with MSI-H tumors for treatment with KEYTRUDA® (pembrolizumab).
Represents Promega’s first NMPA-cleared companion diagnostic for Merck’s anti-PD-1 therapy.

2 days ago

Press Release

Merck & Co. partner Daiichi Sankyo initiates clinical development of DS3790

MRK

New Projects/Investments

The first-in-human phase 1/2 trial for DS3790 has dosed its first patient in relapsed/refractory B-cell non-Hodgkin lymphoma, marking the entry of the first DXd ADC in hematology from Daiichi Sankyo’s portfolio.
DS3790 is a CD37-directed DXd antibody drug conjugate, representing a potential first-in-class therapy for B-cell cancers with no approved CD37-targeted treatments.
The multicenter, open-label trial will enroll approximately 420 patients across Asia, Europe and North America, evaluating safety endpoints like dose-limiting toxicities and efficacy endpoints including overall response and progression-free survival.
CD37, a transmembrane protein overexpressed on malignant B-cells, underscores DS3790’s novel mechanism within Daiichi Sankyo’s seven DXd ADCs developed using proprietary technology.

3 days ago

Press Release

Merck & Co. subsidiary Rakovina Therapeutics gains industry validation at DDR Summit

MRK

New Projects/Investments

Industry feedback confirmed Rakovina’s brain-penetrant ATR/mTOR inhibitor targeting PTEN-deficient tumors addresses critical gaps in DDR therapeutics.
At the 9th Annual DDR Inhibitors Summit, the company showcased its AI-driven dual-targeting kt-5000 series, distinguishing it from current clinical candidates with enhanced brain penetration.
Pharmaceutical partners expressed interest in using the kt-3000 series as novel ADC payloads, prompting Rakovina to prioritize proof-of-concept studies.

3 days ago

Press Release

Merck & Co. secures China approval for Promega MSI detection kit

MRK

Product Launch

China’s NMPA approved Promega’s OncoMate® MSI detection kit as a Class III in vitro diagnostic, enabling companion testing for Keytruda® in MSI-high solid tumors.
The approval, the first of its kind in China for Promega, was granted in collaboration with Merck & Co., reflecting joint efforts to expand precision oncology tools.
The PCR-based kit evaluates microsatellite instability to guide anti-PD-1 therapy decisions in solid tumor patients.
This authorization follows prior approvals of Promega’s MSI technology in the EU and US and precedes its availability for purchase in China.

3 days ago

Press Release

Merck & Co. receives NMPA approval for MSI detection kit

MRK

Product Launch

Chinese National Medical Products Administration approves OncoMate® Microsatellite Instability Detection Kit as a Class III in vitro diagnostic, marking the first Promega complementary diagnostic to gain NMPA approval.
The kit is designed to identify MSI-High solid tumor patients eligible for treatment with KEYTRUDA® (pembrolizumab) in China.
Promega states this approval advances personalized cancer treatment in China.

3 days ago

Press Release

Merck reports Q4 2025 results

MRK

Earnings

M&A

Guidance Update

Q4 revenues of $16.4 billion, up 5% (4% ex-FX), driven by oncology and animal health, with Keytruda sales rising 5% to $8.4 billion
Welireg sales grew 37% to $220 million, while Gardasil declined 35% to $1 billion, and Winrevair generated $467 million in cardiometabolic and respiratory
2026 outlook expects growth from new product launches, continued oncology and animal health strength, despite headwinds of $2.5 billion from generics, IRA pricing, and a $3 billion share repurchase plan
Completed acquisitions of Verona Pharma and Cidara Therapeutics, expanding a pipeline with > $70 billion of mid-2030s commercial opportunity from 20+ new growth drivers