USFDAMay 4, 2026, 08:03 AM
Clene Receives Positive FDA Feedback for CNM-Au8 ALS Accelerated Approval
AI Summary
Clene Inc. announced receipt of final meeting minutes from its Type C meeting with the FDA, confirming that the proposed data for CNM-Au8 may support an NDA submission under the accelerated approval pathway for ALS. The FDA acknowledged that neurofilament light (NfL) could potentially serve as a reasonably likely surrogate endpoint. Clene plans to submit its NDA for CNM-Au8 in the third quarter of 2026, representing a critical step for the potential first-in-class therapeutic approach for ALS.
Key Highlights
- FDA stated proposed data may support NDA submission under accelerated approval pathway for CNM-Au8 for ALS.
- FDA acknowledged neurofilament light (NfL) could potentially serve as a reasonably likely surrogate endpoint.
- Clene expects to submit an NDA for CNM-Au8 to the FDA in the third quarter of 2026.
- The submission will be under the Subpart H accelerated approval pathway (21 CFR 314.510) in ALS.
- Clene will include additional information in the NDA to support the connection between NfL reduction and clinical benefit.
- CNM-Au8 has previously received Orphan Drug Designation from the FDA for ALS treatment.
- Clene intends to commence a Phase 3 confirmatory study for CNM-Au8 in the first quarter of 2027.
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