Curated News
By: NewsRamp Editorial Staff
December 10, 2024

Clene (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Application for CNM-Au8 ALS Treatment

TLDR

  • Clene received FDA guidance to support accelerated approval application for CNM-Au8, its treatment for ALS, giving them an advantage in the race to bring a transformative therapy to market.
  • The FDA recommended using neurofilament light chain biomarker analyses to substantiate CNM-Au8's efficacy, and Clene plans to submit additional data in mid-2025 alongside commencing the Phase 3 RESTORE-ALS trial.
  • Clene's significant survival benefits and benign safety profile of CNM-Au8 underscore its potential as a transformative ALS therapy, addressing the urgent unmet needs of ALS patients.
  • Clinical findings presented at an FDA meeting highlighted CNM-Au8's potential as a transformative ALS therapy, offering hope to those affected by this devastating disease.

Impact - Why it Matters

This news matters as it highlights significant progress in the development of a potential treatment for ALS, a devastating neurodegenerative disease. The FDA guidance and ongoing clinical trials offer hope for ALS patients and their families, signaling a potential breakthrough in addressing the urgent unmet needs of those affected by the disease.

Summary

Clene (NASDAQ: CLNN) received FDA guidance on leveraging data from its ongoing expanded access programs (“EAPs”) to support an accelerated approval application for CNM-Au8, its treatment for ALS. The FDA recommended using neurofilament light chain (“NfL”) biomarker analyses to substantiate the drug’s efficacy. Clene plans to submit additional data in mid-2025, alongside commencing the Phase 3 RESTORE-ALS trial. Clinical findings presented at an FDA meeting highlighted CNM-Au8’s significant survival benefits and benign safety profile, underscoring its potential as a transformative ALS therapy. Clene remains committed to addressing the urgent unmet needs of ALS patients.

To view the full press release, visit https://ibn.fm/xFrwd

About Clene Inc. Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.

Source Statement

This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Application for CNM-Au8 ALS Treatment

blockchain registration record for the source press release.