As good as a handshake, Replimune (NASDAQ: REPL) stock surges 40% on FDA approval path agreement

Replimune Group (NASDAQ: REPL) shares surged 40% Friday after the company reached an agreement with the Food and Drug Administration on a path to resubmit its experimental advanced melanoma treatment for approval, according to a report from the Wall Street Journal, citing people familiar with the matter.

The company plans to resubmit the application in the coming days, the people said. It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.

The development marks a reversal for a drug that became one of the most contentious rejections for the agency under the leadership of former FDA Commissioner Marty Makary. The shift illustrates how quickly priorities are changing at the agency following the commissioner’s departure earlier this month.