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%.
FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed …
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Replimune shares fall after FDA briefing documents questioned RP1 trial data for advanced melanoma ahead of a key advisory…
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty…
A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance…
The FDA rejected vusolimogene oderparepvec twice under former Commissioner Marty Makary, who stepped down earlier this month
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and…
Replimune Lead Drug Trial Data Deemed 'Not Interpretable' by FDA Staff - Replimune Group (NASDAQ:REPL)
FDA Staff Unconvinced Drug for Melanoma Shows Benefit
FDA staff reiterate concerns about Replimune skin cancer treatment
Sanofi halts development of troubled immune drug in eczema
Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback
Capricor Therapeutics Shares Dive Before Key Review as FDA Panel Challenges Data - Capricor Therapeutics
