Curated News
By: NewsRamp Editorial Staff
August 21, 2025
Clene Advances CNM-Au8 Toward FDA Submission for ALS Treatment
TLDR
- Clene Inc. plans to submit an NDA for CNM-Au8 in ALS by end-2025, potentially gaining first-mover advantage in neurodegenerative treatments.
- Clene will submit an NDA for CNM-Au8 in ALS after FDA meetings in Q3 2025 and neurofilament light data analysis in early Q4 2025.
- CNM-Au8 aims to treat ALS and MS by improving mitochondrial health, offering hope for better neurodegenerative disease management.
- Clene's gold nanocrystal oral suspension enhances neuronal energy metabolism, with key regulatory milestones set through 2025.
Impact - Why it Matters
This development matters because ALS (amyotrophic lateral sclerosis) is a devastating neurodegenerative disease with limited treatment options and no cure. Current therapies primarily address symptoms rather than slowing disease progression. If CNM-Au8 receives FDA approval, it could represent the first treatment that actually improves neuronal function and survival for ALS patients. The neurofilament light biomarker data being analyzed could provide objective evidence of neuroprotection, which would be a significant breakthrough in neurology. For the approximately 30,000 Americans living with ALS and their families, this represents hope for extended survival and improved quality of life. The financial stability indicated by the extended cash runway into 2026 suggests Clene has the resources to see this through regulatory review, making this more than just another experimental treatment—it's a potentially viable near-term solution for a disease that has seen few therapeutic advances in decades.
Summary
Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, is making significant strides toward regulatory approval for its innovative treatment CNM-Au8® in amyotrophic lateral sclerosis (ALS). The company plans to submit a New Drug Application (NDA) by year-end 2025, following scheduled FDA meetings in Q3 2025 that will address ALS survival benefit data and multiple sclerosis (MS) development plans. This progress is supported by promising neurofilament light biomarker data analysis from the NIH-sponsored EAP program, expected in early Q4 2025, which could provide critical validation of the treatment's efficacy.
The company's lead asset, CNM-Au8, is an oral suspension of gold nanocrystals designed to restore neuronal health by improving energy metabolism—a groundbreaking approach to treating neurodegenerative diseases. Recent financial results show $7.3 million in cash and cash equivalents as of June 30, 2025, with recent financing extending the company's cash runway into Q1 2026, ensuring continued development momentum. Clene recently held a Type C meeting with the FDA to align on statistical methodology for analyzing biomarker changes, demonstrating regulatory engagement and commitment to bringing this potential breakthrough to patients.
This development represents a crucial advancement in the fight against ALS, a devastating disease with limited treatment options. The company's progress, documented through platforms like BioMedWire and the Dynamic Brand Portfolio, highlights the growing importance of innovative biopharmaceutical approaches in addressing unmet medical needs. With neurofilament light data analysis on the horizon and regulatory submissions approaching, Clene is positioning itself as a key player in the neurodegenerative disease treatment landscape.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Clene Advances CNM-Au8 Toward FDA Submission for ALS Treatment
