Clene Inc. announces statistically significant ALS biomarker results supporting accelerated approval pathway for CNM-Au8.
FDA-recommended biomarker analyses show reductions in NfL and GFAP in CNM-Au8 treated participants.
Biomarker improvements associated with longer survival underline CNM-Au8's potential disease-modifying activity.
Statistically Significant Biomarker Reductions
FDA-recommended analyses demonstrate decreased NfL and GFAP levels in participants treated with CNM-Au8.
Association with Improved Survival
The biomarker improvements are linked to longer survival in ALS patients, strengthening the case for accelerated approval.
Type C Meeting Requested
Clene has requested a Type C meeting in Q1 2026 to present analyses supporting an NDA submission under the accelerated approval pathway.
- The biomarker analyses present compelling evidence for CNM-Au8's efficacy in ALS treatment.
- Statistically significant decreases in NfL and GFAP levels support the potential disease-modifying activity of CNM-Au8.
Clene's successful completion of FDA-recommended biomarker analyses sets the stage for an accelerated approval pathway for CNM-Au8, showcasing its potential to revolutionize ALS treatment.