🧬 Replimune's RP1 hits FDA roadblock in melanoma bid

Replimune's FDA meeting failed to clarify a route to approval for RP1 after July's surprise rejection in advanced melanoma.

Why It Matters To Oncology

▪ RP1 is an oncolytic immunotherapy targeting antiPD-1resistant melanoma, with a 32.9% response rate in the IGNYTE trial.

▪ FDA's lack of supportive clinical data for accelerated approval highlights growing regulatory scrutiny even in high-need cancer populations.

The Financials

▪ Shares fell ~39% after the latest FDA setback, compounding a >75% drop postcomplete response letter in July.

What They're Saying

▪ CEO Sushil Patel: Company is committed to working with FDA; underscores unmet need and RP1's risk-benefit profile.

▪ KOL Kim Margolin: FDA's decision is "puzzling" amid shifting regulatory dynamics; approval had seemed likely based on prior agency conduct.

What's Next

▪ Replimune is reviewing FDA feedback to determine next steps for RP1; pathway for accelerated approval remains uncertain.