FDA Grants Breakthrough Therapy Designation to Merck & Co., Inc. (MRK)'s Raludotatug Deruxtecan for Platinum-Resistant Ovarian

Merck & Co., Inc. (NYSE:MRK) is one of the 15 Best Stocks to Invest in for Financial Stability.

On September 15, 2025, Merck & Co., Inc. (NYSE:MRK) and Daiichi Sankyo revealed that the FDA granted Breakthrough Therapy Designation to raludotatug deruxtecan for platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers expressing CDH6 after bevacizumab treatment.

The designation is based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 study and is intended to accelerate development and review for patients with significant unmet needs. The drug’s impact is significant, as 65% of ovarian cancer patients expressed CDH6 and up to 80% experienced relapse after standard therapies. With the FDA’s recognition, the milestone marks the first breakthrough designation for raludotatug deruxtecan and the second for the Merck & Co., Inc. (NYSE:MRK)-Daiichi Sankyo oncology collaboration launched in October 2023.

Merck & Co., Inc. (NYSE:MRK), a global healthcare company, develops pharmaceuticals, vaccines, biologics, and animal health products. It is one of the Best Stocks To Buy.

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