Replimune shares fall after FDA briefing documents questioned RP1 trial data for advanced melanoma ahead of a key advisory committee meeting.
Replimmune Group Inc.
(NASDAQ:REPL) stock is trading lower on Tuesday after the U.S.
Food and Drug Administration released briefing documents related to the company's vusolimogene oderparepvec, or RP1, for skin cancer.
The company is seeking accelerated approval for RP1 in combination with Bristol-Myers Squibb Co.
(NYSE:BMY) Opdivo (nivolumab) for advanced melanoma. • Replimune Group stock is among today's weakest performers.
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA Staff Unconvinced Drug for Melanoma Shows Benefit
FDA staff reiterate concerns about Replimune skin cancer treatment
FDA reminds investors that re-evaluations don’t equal new conclusions. Just ask Capricor and Replimune
BMS launches dual immunotherapy for metastatic melanoma
FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove…
Replimune Group (REPL) shares gain on key RP2 & RP1 oncology data presentations at ASCO. Read the clinical trial results.
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
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 will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty…
