Replimune stock soars on FDA priority review for melanoma treatment By Investing.com
Investing.com — Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1, the company’s leading oncolytic immunotherapy, for advanced melanoma and granted it Priority Review status. The FDA’s decision, which comes with a Prescription Drug User Fee Act (PDUFA) action date set for July 22, 2025, has sparked optimism among investors and analysts alike.
The BLA submission is based on the primary analysis data of the IGNYTE trial, which evaluated RP1 in combination with nivolumab in patients with advanced melanoma who had not responded to anti-PD-1 therapies. The FDA’s acceptance of the application is…
