FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS
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Clene Inc. has received guidance from the FDA on a potential accelerated approval pathway for its drug CNM-Au8 in treating ALS, which could expedite its market entry.
December 10, 2024 | 1:45 pm
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Clene Inc. received FDA guidance on an accelerated approval pathway for CNM-Au8 in ALS, potentially expediting its market entry and impacting its stock positively.
The FDA's guidance on an accelerated approval pathway is a significant regulatory milestone for Clene Inc., as it could lead to faster market entry for CNM-Au8. This development is likely to be viewed positively by investors, potentially driving up the stock price in the short term.
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IMPORTANCE 80
RELEVANCE 100