Replimune Receives Complete Response Letter From the FDA for RP1 Biologics License Application ...

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application ...

WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (CRL) from the U.S. Food…

Replimune lead drug rejected by FDA again (REPL:NASDAQ)

Replimune (REPL) stock plunges as the FDA rejects its lead drug RP1 for a type of skin cancer called melanoma. Read more here.

Replimune skin cancer drug that became FDA flashpoint is rejected again

A cancer drug candidate that, rightly or wrongly, became a flashpoint at FDA, fails on a second try at approval.

FDA Review Looms As Replimune Faces Weak Technical Setup - Replimune Group (NASDAQ:REPL)

Replimune awaits FDA decision on RP1 for skin cancer after initial rejection, with weak technicals and prior rejection concerns.

FDA Issues Second CRL for RP1/Nivolumab in Advanced Melanoma

The FDA cited that the data provided for RP1 were insufficient and did not provide substantial evidence of effectiveness for this population.

Replimune: Second CRL May Have Sealed RP1's Fate - It's Hard To See Positives (REPL)

This article was written by Follow Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston BioHealth. The group is for both novice and experienced biotech investors. It provides catalysts to look out for and buy and sell ratings. It also provides product sales and forecasts for all the Bi…