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The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...
11d
Investor's Business Daily on MSNWhy 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 ...
3d
Stocktwits on MSNReplimune Stock Catches Retail Fire As Analyst Says FDA Shakeup Removes 'Major Obstacle' For Skin Cancer Drug's Potential Approval
Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new ...
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 ...
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
Replimune (NASDAQ:REPL) stock surges as Cantor Fitzgerald upgrades, citing improved odds for approval of its lead drug after an FDA leadership change. Read more here.
The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...
Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...
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 securities class action lawsuit, styled Jboor v. Replimune Group, Inc., et al., No. 1:25-cv-12085 (D. Mass.), has been filed and seeks ...
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
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