USFDAMay 4, 2026, 08:07 AM
Clene to file accelerated approval NDA for ALS after FDA meeting
AI Summary
Clene Inc. announced plans to file an accelerated approval New Drug Application (NDA) for CNM-Au8 in amyotrophic lateral sclerosis (ALS) following a successful Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA stated that Clene's proposed data may support an NDA submission under the accelerated approval pathway, acknowledging neurofilament light (NfL) as a potential surrogate endpoint. Clene intends to submit the NDA in the third quarter of 2026, supported by data from Phase 2 HEALEY ALS Platform Trial, RESCUE-ALS Trial, and an NIH-sponsored Expanded Access Protocol. A Phase 3 confirmatory study for CNM-Au8 is planned to commence in the first quarter of 2027.
Key Highlights
- FDA stated proposed data may support accelerated approval NDA for ALS.
- FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint.
- Clene expects to submit NDA for CNM-Au8 in Q3 2026.
- NDA supported by NfL biomarker and clinical data from Phase 2 HEALEY ALS and RESCUE-ALS trials.
- Phase 3 confirmatory study for CNM-Au8 to commence in Q1 2027.
- CNM-Au8 previously received Orphan Drug Designation from FDA for ALS.