Replimune's Melanoma Therapy Rejected by FDA, Shares Drop Sharply
Replimune Group's shares fell approximately 63% after the FDA issued a Complete Response Letter (CRL) rejecting its lead melanoma therapy RP1 in combination with nivolumab. The rejection is a major setback for the company, which had based its approval request on data from the IGNYTE clinical program showing a 34% response rate and a median duration of response of 24.8 months. Analysts have downgraded the stock and expressed concerns over the company's future prospects.
Tickers: $REPL
Topics: biotechnology clinical trials drug approval FDA stock price