Biotech firm Replimune’s stock price plummeted 76% after the FDA rejected its request for accelerated approval of cancer treatment candidate RP1. The drug, designed to target melanoma, was based on a phase 1/2 trial showing a 32.9% objective response rate in patients who had previously failed other treatments. However, the FDA cited issues with the study’s design and patient population as reasons for rejection. Replimune plans to request a meeting with the agency to find an alternative path forward for RP1.
Source: https://www.fiercebiotech.com/biotech/replimunes-request-melanoma-approval-rejected-fda-cratering-stock