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.

1 day 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.

1 day 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.

3 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.

3 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.

3 days ago

Press Release

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

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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.

4 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.

4 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.

4 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.

4 days ago

Press Release

Merck reports Q4 2025 results

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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