Wedbush ‘surprised’ by Replimune CRL, downgrades to Neutral

Wedbush analyst Robert Driscoll downgraded Replimune (REPL) to Neutral from Outperform with a price target of $4, down from $19, after the company received a complete response letter from the FDA regarding RP1 in combination with nivolumab as a treatment for PD-1 refractory melanoma patients. Wedbush is “surprised” by the CRL citing Replimune’s previous positive interactions with the FDA, but says new Center for Biologics Evaluation and Research Director Vinay Prasad is clearly playing a key role. The CRL indicates the design of Replimune’s ongoing confirmatory Phase 3 study has issues that need to be addressed including contribution of components, adds Wedbush.