JPMorgan downgrades Replimune to Neutral following CRL for cancer drug

As previously reported, JPMorgan downgraded Replimune (REPL) to Neutral from Overweight with a price target of $9, down from $19, post the complete response letter from the FDA for lead asset RP1 + nivolumab in anti-PD1 failed melanoma. The firm says the complete response letter for RP1 comes as “a complete shock,” given the strength of the known data and regulatory proceedings to data. Indeed, its sense is that the company and Agency were fine tuning the language in the label, before the 11th-hour reversal in decision. JPMorgan adds that the belief in RP1, pipeline optionality, the management, and current valuation is balanced by the uncertainty from a regulatory perspective, as well as more to prove from pipeline products beyond RP1.