FDA Reviewers Say Melanoma Trial Data Cannot Be Verified as Advisers Weigh a Third Review

Replimune: 'Sell' Continued Doubt On Single-Arm IGNYTE Trial For RP1 FDA Review (REPL)

Replimune Group, Inc. downgraded to Sell ahead of FDA Adcom on RP1+Opdivo in melanoma. Click for this REPL update.

FDA expert committee votes in favor of Replimune’s melanoma treatment

Replimune's melanoma drug RP1, rejected in April, gains reprieve under new FDA leadership as advisory committee votes in favor of therapy.

FDA Reviewers Say Melanoma Trial Data Cannot Be Verified as Advisers Weigh a Third Review

FDA reviewers say Replimune's RP1 melanoma data confound interpretation. Advisers meet July 30 ahead of an August 2 decision on a third review.

RP1's Long Road: A Timeline of RP1's Regulatory Journey in Advanced Melanoma

As the FDA's ODAC prepares to weigh in ahead of an August 2, 2026, decision date, take a look at RP1's clinical trial and regulatory journey.