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Merck & Co., Inc. (MRK) Advances Oncology Pipeline with Breakthrough FDA Designation for Ovarian Cancer Drug
Yahoo Finance· 2025-09-28 22:42
Core Insights - Merck & Co., Inc. is identified as one of the most undervalued stocks in the Dow, recognized for its leadership in pharmaceuticals, vaccines, biologics, and animal health products [1] Group 1: Recent Developments - The FDA approved KEYTRUDA QLEX, a new subcutaneous injectable formulation of Keytruda, on September 19, 2025, which enhances patient convenience by reducing administration time from 30 minutes to 1-2 minutes [2] - In Europe, Merck received a positive opinion from the European Medicines Agency for ENFLONSIA (clesrovimab), a preventive for RSV in infants, which would be the first weight-independent option for this demographic if approved [3] Group 2: Financial Performance - Merck reported strong Q2 2025 results, with analysts highlighting its robust vaccine franchise, animal health segment, and innovative oncology treatments, including combination therapies with Keytruda [4] - The company is advancing novel drug candidates, such as raludotatug deruxtecan, which has received FDA Breakthrough Therapy Designation for treating platinum-resistant ovarian and related cancers [4]
Merck & Co., Inc. (MRK) Received FDA Approval For Keytruda Qlex, Cutting Infusion Time to 2 Minutes
Yahoo Finance· 2025-09-23 23:02
Core Insights - Merck & Co., Inc. is recognized as one of the top pharmaceutical stocks to buy, ranking fourth among selections by billionaires [1] - The company is enhancing its leadership in oncology and vaccines, particularly with the recent FDA approval of Keytruda Qlex, a subcutaneous version of the drug [2][4] Product Developments - The FDA approved Keytruda Qlex, which allows for administration in one to two minutes, significantly reducing the infusion time from 30 minutes [2][4] - Keytruda Qlex is expected to launch in the U.S. by late September 2025, improving patient and provider convenience and strengthening Merck's competitive position against biosimilars [2] - In Europe, the EMA's CHMP issued positive opinions for Keytruda, supporting its approval for the EU market and recommending its use in earlier-stage locally advanced head and neck cancer [3] Vaccine Advancements - Merck is advancing its vaccine portfolio, with a positive opinion from the CHMP for ENFLONSIA (clesrovimab), aimed at preventing respiratory syncytial virus (RSV) in infants [4] - If approved, ENFLONSIA would be the first uniform-dose preventive option for RSV in Europe, showcasing Merck's commitment to expanding its vaccine offerings [4] - The company is also making progress with new pneumococcal vaccines, which have shown promising trial results [4]