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Clene Submits FDA Application Seeking Accelerated Approval for ALS Drug

MixedHigh impact
CLNN$3.10 −6.20%

Clene Inc. (CLNN) submitted a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval for CNM-Au8, a treatment for amyotrophic lateral sclerosis (ALS). Alongside the application, the company is preparing its confirmatory Phase 3 trial, known as the RESTORE-ALS study.

Securing accelerated approval would allow the company to bring the drug to market earlier, prior to completing full confirmatory study data. Despite the regulatory filing, shares of Clene Inc. dropped 6.20% today to $3.10.

Going forward, investors will be monitoring for formal acceptance of the filing by regulators, which would establish review milestones and timelines. Key execution factors ahead include managing funding needs and timeline progression for the upcoming Phase 3 trial.

Key points

  • Clene Inc. submitted an NDA to the FDA seeking accelerated approval for its ALS candidate CNM-Au8.
  • The company is preparing a confirmatory Phase 3 trial designated as the RESTORE-ALS study.
  • Accelerated approval could permit early market entry prior to final confirmatory trial results.
  • Clene Inc. shares declined 6.20% to $3.10 following the submission.

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Questions and answers

What did Clene Inc. submit to the FDA?

Clene Inc. submitted a New Drug Application seeking accelerated approval for CNM-Au8 to treat amyotrophic lateral sclerosis.

What is the RESTORE-ALS study?

RESTORE-ALS is a planned confirmatory Phase 3 trial that Clene Inc. is preparing as part of its regulatory process.

How did Clene Inc. stock perform following the news?

Shares of Clene Inc. fell 6.20% to $3.10.