Cantor Fitzgerald downgraded Replimune (REPL) to Neutral from Overweight without a price target after the FDA issued a complete response letter for RP1 in advanced melanoma citing the lack of “adequate and well-controlled clinical investigation.” The stock in premarket trading is down 78% to $2.75. The downgrade reflects the probability that the FDA is going to require a randomized controlled trial in order to support approval of RP1, the analyst tells investors in a research note. Cantor believes the study will likely take years to conduct and result in RP1 giving up its lead time to market. The firm is now skeptical RP1 will make it to market.
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