Key Takeaways Replimune shares fell 54.2% in three months after the FDA issued a CRL against its RP1 BLA in July.The FDA cited shortcomings in the IGNYTE study data but noted no safety concerns with RP1.Replimune met with the FDA to discuss next steps, with a clear regulatory path still uncertain.Replimune Group’s (REPL) share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics license applicati ...

Key Points A crucial meeting with a regulator didn't seem to go well. It was about a leading pipeline drug being developed by the company. 10 stocks we like better than Replimune Group › On Thursday, Replimune (NASDAQ: REPL) had a crucial meeting with federal regulators regarding one of its leading drug candidates. While the outcome of the event wasn't necessarily negative, it left the future of the drug up in the air, and investors didn't like that uncertainty. As a result, they assertively traded ...

WATERTOWN, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned NDA submission for bitopertin in EPP. "At the pre-NDA meeting, we confirmed alignment wit ...