Street View: Tough path ahead for Replimune after second FDA setback on melanoma drug

Replimune

13/04/2026 13:21

** Shares of Replimune REPL.O fall 63.66% to $1.73 premarket

** U.S. Food and Drug Administration on Friday declined to approve Replimune's drug for advanced skin cancer, citing insufficient data from studies

** At least three analysts cut PT on company

COMPANY IN SIGNIFICANT CRISIS

** Wedbush ("neutral," PT: $2) says second complete response letter is "disappointing" given what brokerage views as convincing treatment effect in patient population with significant unmet need

** BMO Capital Markets ("underperform," PT: $1) says company is left with long and financially challenging path forward

** J.P. Morgan ("underweight") anticipates company will likely need to restructure and deprioritize earlier stage pipeline efforts

** H.C. Wainwright ("sell") says it may take REPL until late in this decade to furnish agency with data that it appears to be demanding, downgrading to stock to sell without price target

** Adds there can be no assurance that Replimune would be able to accomplish this, as company is facing significant crisis and may not be able to pivot successfully

** Jefferies ("buy," PT: $2) says content of letter is more severe than expected

 (Reporting by Kunal Das in Bengaluru)

 ((Kunal.Das2@thomsonreuters.com;))