News

Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...
The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...
Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...
Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...
Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...