Cautious Outlook on Replimune Group Amid FDA Uncertainties and Potential Risks

Evan Seigerman, an analyst from BMO Capital, maintained the Sell rating on Replimune Group. The associated price target remains the same with $2.00.

Evan Seigerman has given his Sell rating due to a combination of factors surrounding Replimune Group’s recent developments. Despite a positive shift in the FDA’s stance on the RP1 data package, there remains uncertainty about the potential approval of RP1, especially given the FDA’s historically tough position on single-arm trials. The company’s previous complete response letter (CRL) and the possibility of needing to re-run key studies present significant risks that could lead to underperformance compared to industry peers.
While the resubmission of RP1 in combination with nivolumab for advanced melanoma has been accepted by the FDA, the market reaction reflects a cautious optimism rather than a guaranteed success. The potential for approval by April 2026 provides some hope, but the ongoing changes in FDA leadership and their impact on the approval process add layers of unpredictability. Therefore, Seigerman remains cautious about Replimune’s ability to navigate these challenges successfully, warranting a Sell rating.