Iovance climbs after FDA rejection for Replimune’s skin cancer drug

The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to have boosted its rival, Iovance Biotherapeutics (NASDAQ:IOVA), whose lead product Amtagvi is marketed for a similar indication in the U.S.

REPL shares crashed ~73%, triggering several trading halts on Tuesday after the company disclosed that the FDA issued a complete response letter, rejecting its marketing application for RP1 targeted at patients with advanced melanoma.

Replimune’s (NASDAQ:REPL) Biologics License Application sought the U.S. approval of the immunotherapy with Bristol Myers’ (BMY) anti-PD-1 therapy Opdivo based on the company’s IGNYTE trial. The Phase 1/2 study’s registration-directed Phase 2 expansion cohort included anti-PD1 failed melanoma patients.

In the CRL, the FDA had highlighted its concerns, noting that IGNYTE was not sufficient and well-controlled clinical trial that could show RP1’s efficacy.

Iovance (NASDAQ:IOVA) whose shares have climbed ~16%, won FDA approval for Amtagvi in 2024 for patients with unresectable or metastatic melanoma who had previously undergone multiple therapeutic options, including PD-1 blocking antibodies.