ALPN - FDA lifts partial clinical hold on Alpine Immune's davoceticept for malignancies

Alpine Immune Sciences (NASDAQ:ALPN) said on Tuesday the U.S. Food and drug Administration had removed the partial clinical hold placed on trial evaluating its drug candidate davoceticept in combination with Merck's (MRK) Keytruda (pembrolizumab) in adults with advanced malignancies. The agency had placed the partial clinical hold following the death of a patient in March. "The FDA removed the hold after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol," the company said. Under the terms of the hold, previously enrolled participants will continue to receive the study drug, but no new participants can be enrolled until the partial clinical hold is removed. (ALPN) rose 2.5% before the bell.

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FDA lifts partial clinical hold on Alpine Immune's davoceticept for malignancies