Clene says FDA open to accelerated approval review for CNM-Au8 ALS NDA
PUBT · 19h ago
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- Clene received final FDA minutes indicating its CNM-Au8 data package could support submission and review of an accelerated approval NDA for ALS, using neurofilament light as a potential surrogate endpoint.
- NDA filing targeted for Q3 2026, with FDA requesting added analysis linking size of neurofilament light reduction to clinical benefit.
- Phase 3 confirmatory study planned to start in Q1 2027.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605040800PRIMZONEFULLFEED9712093) on May 04, 2026, and is solely responsible for the information contained therein.
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