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FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove efficacy. Shares fell 30%.
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medpagetoday.com
FDA Staff Unconvinced Drug for Melanoma Shows Benefit
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
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statnews.com
FDA staff reiterate concerns about Replimune skin cancer treatment
Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
