Clene announces FDA agrees CNM-Au8 data may support accelerated approval NDA for ALS

Clene Inc.

FDA stated proposed data may support NDA submission under accelerated approval pathway for ALS.
FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.
Clene expects to submit NDA for CNM-Au8 in Q3 2026; Phase 3 confirmatory study to start Q1 2027.
NDA supported by NfL and clinical data from Phase 2 trials and NIH-sponsored Expanded Access Protocol.
CNM-Au8 previously received Orphan Drug Designation from FDA for ALS treatment.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.