Replimune Stock Surges 85% on FDA Priority Review for Skin Cancer Drug

The U.S. Food and Drug Administration (FDA) has accepted Replimune's (NASDAQ: REPL) Biologics License Application (BLA) for its experimental drug RP1 to treat advanced melanoma, granting priority review. The announcement sent the company's stock soaring 85% in pre-market trading.

Regulatory Details

Replimune submitted a BLA for RP1, a genetically modified herpes simplex virus-based immunotherapy, for patients with unresectable advanced melanoma. The FDA granted priority review, shortening the review period to 6 months from the standard 10 months.

Company's Position

Replimune stated that RP1 demonstrated durable response rates in clinical trials among patients who had failed prior therapies. The company emphasized the unmet need for advanced melanoma treatments.

Precedents and Context

This is Replimune's second attempt to gain FDA approval for RP1 after a rejection in 2023 due to manufacturing data deficiencies. The company has since submitted additional data to address those concerns.

Potential Financial Impact

If approved, RP1 could enter a market worth over $2 billion annually for melanoma treatment. However, competition is intense from established therapies by Bristol-Myers Squibb (BMY) and Merck.