REPL - Replimune ends selloff after FDA response to mid-stage cancer trial

• Following four straight sessions of losses, oncology-focused biotech Replimune Group ( NASDAQ: REPL ) added ~7% on Monday after announcing a favorable response from the FDA regarding its Phase 2 trial CERPASS for lead asset RP1.
• The company has already completed patient enrollment for CERPASS, in which RP1 is tested along with Regeneron’s ( REGN ) anti-PD-1 therapy cemiplimab (Libtayo) in cutaneous squamous cell carcinoma.
• Replimune ( REPL ) shares fell early this month after the company disclosed in its latest 10Q filing that the FDA raised certain issues related to CERPASS, including those on study endpoints, for further discussion.
• In a subsequent regulatory filing on Monday, the company said that the FDA agreed that no modifications were needed for the CERPASS trial protocol, and its data analysis plan would also require “no material changes.”
• Replimune ( REPL ) continues to expect a Biologics License Application filing for RP1 in early 2024, subject to a positive study outcome.
• Read: Seeking Alpha contributor issued a Hold rating on Replimune ( REPL ) in November after Roche ( OTCQX:RHHBY ) inked a new collaboration deal with the company.

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