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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]
FDA Grants Breakthrough Therapy Designation to Merck & Co., Inc. (MRK)’s Raludotatug Deruxtecan for Platinum-Resistant Ovarian
Yahoo Finance· 2025-09-22 21:32
Group 1 - Merck & Co., Inc. has received Breakthrough Therapy Designation from the FDA for raludotatug deruxtecan, targeting platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers expressing CDH6 after bevacizumab treatment [2][3] - The designation is based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 study, aimed at accelerating development for patients with significant unmet needs [3] - Approximately 65% of ovarian cancer patients express CDH6, and up to 80% experience relapse after standard therapies, highlighting the drug's potential impact [3] Group 2 - Merck & Co., Inc. is recognized as one of the best stocks to invest in for financial stability and is involved in developing pharmaceuticals, vaccines, biologics, and animal health products [1][4] - The collaboration between Merck and Daiichi Sankyo marks the second breakthrough designation for their oncology partnership, which began in October 2023 [3]