Replimune downgraded to Neutral at Piper Sandler after second CRL

Piper Sandler downgraded Replimune (REPL) to Neutral from Overweight with a price target of $4, down from $14, after the FDA issued a second rejection of RP1 in second-line melanoma following a first complete response letter last July. Today’s “rather lengthy CRL” specifies that this decision, from a new review team, was unanimous, and makes it clear that FDA’s concern on the contribution of components in the single-arm IGNYTE trial were not addressed with Replimune’s new analyses, as well as raising new concerns, the analyst tells investors. Following this second CRL, the firm sees “no path for accelerated approval” and calls the path to approval for RP1 based on the ongoing IGNYTE-3 trial “extremely uncertain.”