Replimune’s oncolytic immunotherapy RP1 cleared an FDA regulatory milestone, receiving an early August decision date after a resubmission for advanced melanoma. The FDA set an advisory committee meeting window for late July and expects a verdict on or before Aug. 2, giving the biotech a third regulatory attempt after two prior rejections. The earlier setbacks centered on whether Replimune’s pivotal study met FDA standards for “adequate and well-controlled” evidence and whether the company’s data package supported “substantial evidence of effectiveness.” The latest pathway follows leadership changes at the agency, and Replimune and the FDA aligned on a revised submission approach. Separately, BIOCENTURY reports that upcoming FDA adcomms are poised to test the agency’s post-Makary advisory posture, with contested review discussions for Replimune and Capricor among the items on the calendar.