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Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision

Source: marketbeat.com

Healthcare & BiotechRegulation & LegislationCorporate Guidance & Outlook
Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision

Clene (NASDAQ: CLNN) plans to submit a new drug application to the FDA in early Q4 for CNM-Au8, its investigational treatment for amyotrophic lateral sclerosis (ALS). The planned filing is a regulatory milestone that could materially affect the company’s valuation, although approval remains uncertain.

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