FDA Review Looms As Replimune Confronts Weak Technical Setup

Corroborated by 4 sources from 4 publishers

ushealth2d ago

TL;DR

The Food and Drug Administration on Friday rejected again an experimental treatment for advanced skin cancer developed by Replimune Group. Replimunes treatment, an engineered virus designed to rev … [+678 chars] Replimune Plunges After FDA Rejects Skin Cancer Drug Again News is breaking today that Replimune Group, Inc.'s (REPL) Biologics License Application ("BLA") requesting approval for its drug candidate RP1 (vusolimogene oderparepvec) in the indication of anti-PD-1 failed melanoma has been rejected by the FDA - the second time Replimune: Second CRL May Have Sealed RP1's Fate - It's Hard To See Positives Summary - Replimune Group, Inc. suffered a second FDA rejection for RP1 in anti-PD-1 failed melanoma, causing a sharp stock decline and casting doubt on its near-term prospects.

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