Key Points On July 22, 2025, the U.S. Food and Drug Administration issued a Complete Response Letter for RP1, delaying potential commercialization and revenue. Research and development expenses ...

Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic ...

Hearing minnow Audeara has entered an alliance with Ear Science Institute Australia to develop an affordable bone conduction hearing device.

Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the ...

The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into ...

Replimune (REPL) stock plummets as report suggests FDA’s top regulator of cancer drugs intervened in rejecting its lead asset ...

The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, ...

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf ...

Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...