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Replimune: FDA Rejects Application Seeking RP1 Approval
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 letter, indicating the agency won't approve the clinical-stage biotechnology company's application in its current form.
The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...
Investor's Business Daily on MSN2d
Why Replimune's Surprise Rejection Rattled Wall Street, And Cratered Its StockReplimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...
Iovance Biotherapeutics, Inc. stock faces challenges with disappointing Q1 earnings and competition. Click for why potential ...
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