Clene Files for Accelerated Approval of Oral ALS Therapy

Clene Nanomedicine has submitted a request to the US Food and Drug Administration seeking accelerated approval for its experimental therapy CNM-Au8 for amyotrophic lateral sclerosis. The request follows the failure of two primary endpoints in the clinical trial, according to NeurologyLive.

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• The therapy in question is CNM-Au8, an experimental oral treatment intended for amyotrophic lateral sclerosis.

  «its experimental oral therapy for amyotrophic lateral sclerosis»

  ALS News Today
• The request comes after two primary endpoints failed in the clinical trial, amid the FDA's evolving guidance over the course of years.

  «following 2 missed primary trial endpoints and years of evolving FDA guidance»

  NeurologyLive
• The request was submitted as a New Drug Application (NDA), the format through which accelerated approval is sought.

  «Clene has filed an NDA seeking accelerated approval of CNM-Au8 for ALS»

  NeurologyLive

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