Replimune secured a new timeline for its twice-rejected melanoma therapy RP1 after the FDA accepted the company’s resubmission and set an advisory committee meeting in late July. The agency is targeting a decision on or before Aug. 2 as Replimune pursues accelerated approval for RP1 in advanced melanoma. RP1’s path has been marked by two prior FDA rejections, with the agency previously saying the pivotal study did not meet adequacy criteria and that the package was insufficient to establish substantial evidence of effectiveness. Replimune’s latest round comes amid leadership changes at FDA and a negotiated path forward with regulators after earlier controversy. The development matters for other contested oncology programs, because it highlights how advisory meetings may resume as a central pressure point for disputed evidence packages—especially when approvals hang on whether endpoints and study conduct can be defended under agency review.