Clene Inc., a clinical-stage biopharmaceutical company, announced a regulatory update following a constructive Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA provided supportive feedback on Clene's proposed statistical analysis plan for neurofilament biomarker analysis in its NIH-sponsored Expanded Access Program, which supports nearly 200 ALS patients. The biomarker analyses are scheduled for early in the 4th quarter of 2025. Clene confirmed two additional FDA meetings for the 3rd quarter of 2025 to discuss ALS survival data and their multiple sclerosis $(MS)$ clinical development program. The company is on track to potentially submit a new drug application for ALS under the accelerated approval pathway by the end of 2025.
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