Clene Inc. announced additional biomarker data supporting a potential NDA filing for an upcoming in-person FDA meeting.
The FDA granted Clene an in-person Type C meeting in the first quarter of 2026.
New analyses demonstrate the association between NfL reductions and lower mortality risk, supporting NfL reduction as a candidate surrogate endpoint for accelerated approval.
FDA Meeting Grant
FDA granted Clene an in-person Type C meeting in Q1 2026.
NfL Reductions
Modest NfL reductions are associated with lower mortality risk, supporting it as a candidate surrogate endpoint.
IGFBP7 Biomarker
CNM-Au8 30mg showed a strong association with reduced mortality in responders with IGFBP7 decline.
NfL Trajectory
Longitudinal changes in NfL are associated with survival outcomes independently of baseline disease severity.
CNM-Au8 Treatment
Consistently reduces NfL levels, a critical biomarker in ALS.
- New analyses across large ALS cohorts show associations between NfL reductions and mortality risk.
- CNM-Au8 treatment demonstrates statistically significant NfL reductions and predicts clinical benefits in ALS patients.
- NfL reduction is quantitatively associated with improved survival in ALS patients with even modest reductions showing lower risk of death.
- The findings demonstrate consistent pharmacodynamic effects of CNM-Au8 on a clinically relevant ALS biomarker.
The additional biomarker data presented by Clene Inc. supports the potential for accelerated approval and NDA filing, highlighting the positive impact of CNM-Au8 treatment on ALS patients. These findings pave the way for future advancements in the treatment of neurodegenerative diseases.