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Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...
In an open letter, 22 experts who designed and ran Replimmune’s Phase III IGNYTE trial answered the FDA’s issues, as outlined ...
Shares of Replimune (NASDAQ:REPL) plunged ~38% in the premarket on Monday after Stat News reported that the FDA’s top ...
The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, ...
WOBURN, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today ...
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Replimune Shares Slide as FDA Dispute Over Cancer Drug Approval Comes to Light
Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the ...
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest ...
The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...
A cancer-killing virus could soon be approved for use after shrinking tumours in a third of people with late-stage melanoma ...
RP1’s “infinitely scalable” platform can synchronously connect hundreds of millions of users to one another in a real-time, persistent virtual world, without the need for sharding, said Mann.
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