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Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

Clene Inc. (CLNN)Clene Inc.FDA / regulatory

Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on revolutionizing the treatment of neurodegenerative diseases, announced that it has submitted a New Drug Application (NDA) earlier in October to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of CNM-Au8 ® for the treatment of amyotrophic lateral sclerosis (ALS).

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Clene Inc.

Neurodegenerative-Disease Nanomedicine Clene is a late clinical-stage biopharmaceutical company developing nanotechnology-based therapies intended to improve mitochondrial health and preserve neuronal function. Its programs target neurodegenerative diseases including amyotrophic lateral sclerosis, multiple sclerosis, and Parkinson's...

Recent company news

CLNNClene Inc.2026-10-19 12:00 EST

Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

CLNNClene Inc.2026-09-22 12:00 EST

Clene to Present at Upcoming Investor Conferences

CLNNClene Inc.2026-09-21 12:30 EST

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

CLNNClene Inc.2026-09-15 13:00 EST

Clene Announces $4 Million Registered Direct Offering

CLNNClene Inc.2026-09-03 12:00 EST

Clene to Present at Upcoming September Investor Conferences

Stock data

Close
3.76 USD
Market cap
75.01M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States