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Managed Healthcare Executive2d
FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
Replimune: A Surprise CRL Exposes Fragility Of The Melanoma Program
Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...
Medscape22h
FDA Declines to Approve New Melanoma Therapy
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
Investor's Business Daily on MSN2d
Why Replimune's Surprise Rejection Rattled Wall Street, And Cratered Its Stock
Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...
pharmaphorum1d
Replimune receives CRL on BLA for RP1 for advanced melanoma
Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...
The American Journal of Managed Care6h
RP1 Plus Nivolumab Receives CRL for Advanced Melanoma
The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...
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EQUITY ALERT: Rosen Law Firm Files Securities Class Action Lawsuit on Behalf of Replimune Group, Inc. Investors - REPL
Rosen Law Firm, a global investor rights law firm, announces it has filed a class action lawsuit on behalf of purchasers of the securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, ...
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Barclays Downgrades Replimune Group (REPL)
Fintel reports that on July 23, 2025, Barclays downgraded their outlook for Replimune Group (NasdaqGS:REPL) from Overweight to Equal-Weight. Analyst Price Forecast Suggests 725.97% Upside As of July ...