Clene Inc. Receives FDA Approval for In-Person Meeting in 2026, NfL Reductions Linked to Lower ALS Mortality Risk
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
0mins
Source: Globenewswire
- FDA Meeting Approval: Clene Inc. has received FDA approval for an in-person Type C meeting in Q1 2026 to discuss the association of NfL biomarkers with ALS patient survival, marking a significant step in the company's accelerated approval pathway.
- NfL Reduction and Survival Link: In the HEALEY ALS Platform Trial, CNM-Au8 treatment resulted in approximately 10% reduction in NfL levels, significantly associated with an 8-13% lower mortality risk, indicating potential clinical benefits in rapidly progressive ALS.
- IGFBP7 Biomarker Discovery: The decline in IGFBP7 levels was strongly associated with a 78% reduction in mortality risk among responders to CNM-Au8 treatment, further supporting the importance of this biomarker in ALS therapy and potentially guiding future treatment strategies.
- Clinical Data Support: Clene's pre-meeting briefing package includes statistically significant reductions in NfL and GFAP, suggesting that changes in these biomarkers may predict clinical benefits for ALS patients, enhancing the company's competitive position in the biopharmaceutical sector.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CLNN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on CLNN
Wall Street analysts forecast CLNN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CLNN is 30.40 USD with a low forecast of 30.00 USD and a high forecast of 31.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.170
Low
30.00
Averages
30.40
High
31.00
Current: 4.170
Low
30.00
Averages
30.40
High
31.00
About CLNN
Clene 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. It specializes in the discovery, development, and commercialization of clean-surfaced nanotechnology (CSN) therapeutics. CNM-Au8, the lead asset, is a concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. CNM-Au8’s mechanism of action targets mitochondrial dysfunction by catalyzing the production of nicotinamide adenine dinucleotide. Its CNM-ZnAg is a broad-spectrum antiviral, antibacterial agent comprised of zinc (Zn2+) and silver (Ag+) ions under development to treat infectious disease and to provide immune support for symptom resolution. Its CNM-AgZn17 is a gel polymer suspension of Zn2+ and Ag+ under development for the treatment of infectious diseases and to support wound healing.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Clene Inc. to Present at Emerging Growth Conference on January 21, 2026
- Presentation Schedule: Clene Inc. will present a corporate update at the Emerging Growth Conference on January 21, 2026, at 3:10 p.m. ET, showcasing its latest advancements in treating neurodegenerative diseases, which is expected to attract significant investor interest.
- Innovation Showcase: Clene focuses on improving mitochondrial health and protecting neuronal function, particularly targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), with its investigational therapy CNM-Au8® aiming to enhance central nervous system cell survival through mitochondrial function targeting.
- Webcast Availability: The presentation will be available via a webcast on Clene's website under the “Events” section, and a replay will also be accessible through the conference portal and YouTube channel, ensuring that investors unable to attend live can still access the information.
- Investor Relations Enhancement: The Emerging Growth Conference provides Clene with an effective platform to present its innovative products and services to potential individual and institutional investors, further strengthening the company's market presence in the biopharmaceutical sector.
Continue Reading
Clene Inc. to Present at Emerging Growth Conference on January 21, 2026
- Presentation Schedule: Clene Inc. will present a corporate update at the Emerging Growth Conference on January 21, 2026, at 3:10 p.m. ET, which is expected to attract significant investor interest in its new products and services.
- Webcast Availability: The presentation will be available via webcast on Clene's website under the 'Events' section, and a replay will also be accessible through the conference portal and the Emerging Growth YouTube channel, ensuring investors can access the information at their convenience.
- Company Background: Clene Inc. is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis and multiple sclerosis, showcasing its innovative potential in the biopharmaceutical sector.
- Product Development Highlight: Its investigational therapy CNM-Au8® is a first-in-class treatment aimed at enhancing the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway, indicating promising therapeutic prospects for neurodegenerative diseases.
Continue Reading