News

“We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided ...
Recent discussions on X about Replimune Group Inc. (REPL) have been ignited by the U.S. FDA's rejection of the company's lead drug, RP1, for melanoma treatment in combination therapy. Many users ...
Replimune (REPL) stock slides after as FDA rejects its melanoma drug RP1, boosting shares of Iovance Biotherapeutics (IOVA) which markets a rival drug. Read more here.
Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma ...
Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.
Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma ...
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the ...
The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.
The FDA has issued a CRL to Replimmune regarding the BLA for vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.
In a press release, Sushil Patel, PhD, CEO of Replimune, said, "We are surprised and disappointed by the FDA's decision, as the issues raised in the CRL were not communicated to us during earlier ...