Curated News
By: NewsRamp Editorial Staff
August 14, 2025
Clene Inc. Advances ALS Treatment with FDA Meeting and Biomarker Data Analysis
TLDR
- Clene Inc. secures a financial edge with sufficient cash runway into Q1 2026, aiming for FDA accelerated approval of CNM-Au8 for ALS by end of 2025.
- Clene Inc. plans FDA meetings to review CNM-Au8 survival data in ALS and analyze NIH biomarker data, supporting a potential New Drug Application submission.
- Clene Inc.'s focus on CNM-Au8 development offers hope for ALS patients, potentially improving lives through innovative neurodegenerative disease treatments.
- Clene Inc. advances CNM-Au8, a novel therapy targeting mitochondrial health, with upcoming FDA reviews and biomarker data analyses for ALS treatment.
Impact - Why it Matters
This news is significant for patients suffering from ALS and other neurodegenerative diseases, as it highlights the potential for a new, effective treatment option. The progress of CNM-Au8 through clinical trials and towards FDA approval could offer hope to those affected by these debilitating conditions, marking a pivotal step forward in medical science and patient care.
Summary
Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, has announced its Q2 2025 financial results, revealing a sufficient cash runway extending into Q1 2026. The company is gearing up for a crucial meeting with the FDA this quarter to discuss survival data for its lead candidate, CNM-Au8, aimed at treating amyotrophic lateral sclerosis (ALS). Additionally, Clene is preparing to analyze neurofilament light biomarker data from an NIH-sponsored Expanded Access Program, with results expected in Q4. These efforts are part of Clene's strategy to support a potential New Drug Application submission under the FDA's accelerated approval pathway for ALS by the end of 2025. The company emphasizes its commitment to delivering a transformative therapy for the ALS community. For more details, visit the full press release.
Clene Inc. is dedicated to developing innovative treatments for neurodegenerative diseases, including ALS, Parkinson's disease, and multiple sclerosis, through its focus on mitochondrial health and neuronal function. Its flagship product, CNM-Au8, represents a groundbreaking approach to enhancing cell survival and function in the central nervous system. The company operates from Salt Lake City, Utah, with research and manufacturing facilities in Maryland. Discover more about Clene's pioneering work at www.clene.com.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Clene Inc. Advances ALS Treatment with FDA Meeting and Biomarker Data Analysis
