Zevra Therapeutics Says FDA Has Extended Review Period For New Drug Application For Arimoclomol As Treatment For Niemann-Pick Disease Type C
Portfolio Pulse from Benzinga Newsdesk
Zevra Therapeutics announced the FDA has extended the review period for its new drug application for Arimoclomol, a treatment for Niemann-Pick Disease Type C. The new PDUFA action date is set for September 21, 2024, with plans for an advisory committee meeting. The extension is due to the FDA needing more time to review additional analyses provided by Zevra.
March 04, 2024 | 12:33 pm
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The FDA has extended the review period for Zevra Therapeutics' Arimoclomol, pushing the PDUFA date to September 21, 2024.
The extension of the FDA review period for Arimoclomol is likely to be viewed negatively by investors as it delays potential market entry and revenue generation from this treatment. The delay could impact investor sentiment and the stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100