Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses
Clene (CLNN) plans to submit an NDA for its ALS drug in Q4, following FDA-requested biomarker analyses. The company reported consistent neurofilament reductions across trials and believes its data links biomarker changes to clinical benefits. Clene aims for an FDA decision by year-end and a potential commercialization decision by early 2027.


