FDA Rejects Replimune's Blood Cancer Drug, Stock Sinks - Replimune Group (NASDAQ:REPL)

Replimune rebounds despite analyst downgrades on FDA rejection

FDA Rejects Replimune’s Skin Cancer Treatment, Shares Sink

US regulators rejected a skin cancer treatment from Replimune Group Inc. in another sign of the agency’s new leadership taking a hard line on drug approvals.

Replimune skin cancer therapy rejected by FDA, a sign of regulators' hardened stance

The FDA's decision is the latest indication that the agency is taking a hardened stance on drug approvals under regulatory Vinay Prasad.

Replimune drug rejected by FDA; Omega raises $647M biotech fund

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.

FDA Rejects Replimune's Blood Cancer Drug, Stock Sinks - Replimune Group (NASDAQ:REPL)

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

Replimune Viral-Based Therapy for Melanoma Rejected By FDA

Replimune announced this week that its modified viral therapy for melanoma has been rejected by the FDA, with the regulator citing problems with the Phase I/II IGNYTE study and concerns with planned trials of the therapy as the reason for the rejection. The negative Complete Response Letter from the FDA regarding its approval application for its lead candidate RP1 (vusolimogene oderparepvec) was unexpected, and the company plans to request an ur…