Clene files NDA with FDA seeking accelerated approval for ALS therapy CNM‑Au8
Clene Inc. filed a New Drug Application with the U.S. Food and Drug Administration to obtain accelerated approval for its investigational ALS treatment CNM‑Au8. The submission is based on neurofilament light chain biomarker data and clinical outcomes, and the company said it will launch a confirmatory Phase 3 trial called RESTORE‑ALS while the FDA reviews the filing. The agency has not yet announced a review schedule.
Why it matters
The company notes that FDA clearance would enable earlier market entry for a therapy targeting a serious, unmet‑need disease, potentially driving future sales. The stock rose about 4.5% to $3.24 after the announcement, reflecting immediate investor interest.
Key facts
- 1Clene filed an NDA with the FDA for accelerated approval of CNM‑Au8 to treat ALS. tradingview.com
- 2The filing relies on neurofilament light chain biomarker data and clinical outcomes. investing.com
- 3Clene plans to conduct a confirmatory Phase 3 study named RESTORE‑ALS during the review period. investing.com
- 4The FDA has not yet set a timeline for reviewing the application. tradingview.com
- 5CLNN shares increased 4.52% to $3.24 following the filing announcement. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.