Replimune surges after FDA panel votes in favor of skin cancer drug
REPL•FDA panel backs Replimune melanoma trial results
Shares of drug developer Replimune REPL.O more than doubled to $12.41 premarket after the U.S. FDA's panel of outside advisers on Thursday voted to back results from a trial studying the company's drug for a type of skin cancer.
REPL seeks accelerated approval for RP1 in combination with Bristol Myers Squibb's BMY.N Opdivo in advanced melanoma in patients whose tumors grew despite prior treatment, with a decision expected by August 2.
"Given the media attention surrounding this decision, we think it's a near certainty that the FDA follows the panel's advice" - Cantor Fitzgerald
The brokerage assumes unadjusted peak U.S. sales of $708 million by 2040 for RP1.
Up to the last close, the stock was down 44.3% year to date.
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