FDA Extends Review Period for Syndax Pharmaceuticals' Leukemia Drug Revumenib
Portfolio Pulse from Benzinga Newsdesk
The FDA has extended the review period for Syndax Pharmaceuticals' leukemia drug Revumenib by three months, pushing the PDUFA action date to December 26, 2024. This extension is due to the submission of additional information, which was classified as a Major Amendment.
July 29, 2024 | 11:03 am
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The FDA has extended the review period for Syndax Pharmaceuticals' leukemia drug Revumenib by three months, pushing the PDUFA action date to December 26, 2024. This extension is due to the submission of additional information, which was classified as a Major Amendment.
The extension of the review period by the FDA is a neutral event in the short term as it does not involve additional trials or manufacturing information. However, it delays the potential approval and market entry of Revumenib, which could impact investor sentiment.
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IMPORTANCE 80
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