Merck wins FDA nod for Winrevair label update (MRK:NYSE)

Merck (MRK) received Japanese approval for KEYTRUDA QLEX, a subcutaneous version of its cancer therapy KEYTRUDA. The new formulation allows for faster administration compared to intravenous infusion. This approval is part of Merck's broader effort to offer more convenient cancer treatments, potentially expanding its market opportunity in Japan.

Moderna's shares rose 9% after its Phase 3 melanoma study was selected for a Presidential Symposium at the European Society for Medical Oncology congress. Merck and BioNTech also saw gains. The stock is trading at $167.90. No new data was released, but the high-profile presentation is seen as a positive signal.

Merck (MRK) announced that its KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) has been approved in Japan for subcutaneous use. The approval covers all KEYTRUDA indications. KEYTRUDA QLEX can be administered in one minute, offering convenience. The approval is based on a Phase 3 trial showing comparable efficacy to KEYTRUDA. KEYTRUDA QLEX is also approved in the U.S. and Europe.

Merck & Co Inc (MRK) received approval in Japan for its Keyject subcutaneous injection, a more convenient version of Keytruda. The company's dividend yield is 2.31% with a payout ratio of 1.05, raising sustainability concerns. MRK's stock is 21.6% overvalued according to GF Value™, with a GF Score™ of 76/100. Insider selling totaled $71.4 million over the past year, and the P/E ratio is 117.4x, higher than its 5-year median of 20.19x.

Merck (MRK) awaits FDA decision on Winrevair for pulmonary arterial hypertension. Mirum (MIRM) faces decision on Zilurgisertib for FOP, with Incyte (INCY) holding economic interest. Grail (GRAL) has FDA advisory committee review for Galleri multi-cancer blood test. MRK up 40%, INCY up 23%, MIRM up 17.6%, GRAL down 9%.

Merck (MRK) stock rose 87% in the past year, despite revenue growth of 4.6% to $66.6B. The increase is attributed to investor optimism about future drugs, including the acquisition of Terns Pharmaceuticals for $5.7B. Merck's pipeline showed progress with FDA approvals and positive trial results, but KEYTRUDA's patent expiration in 2028 poses a risk. The company raised its 2026 revenue guidance to $66.3B-$67.3B, indicating a slight deceleration.