After FDA shakeup, Replimune to resubmit twice-rejected drug for approval

TL;DR

Replimune stock surges 40% on FDA approval path agreement Replimune Gets Third Try at FDA Approval After Makary Departure Replimune Soars After FDA Reconsiders Denial of Cancer Drug Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership exodus at the agency, the company said Friday. Replimune said it and the FDA are now aligned on a path forward and the company will resubmit its application in the coming days. Replimune said the FDA has indicated it will treat the application as an urgent matter and will prioritize its review.