Clene Completes Biomarker Analyses for ALS Treatment CNM-Au8
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 03 2025
0mins
Should l Buy CLNN?
Clene and its wholly owned subsidiary Clene Nanomedicine announced completion of the FDA-recommended biomarker analyses for CNM-Au8 in people living with ALS. The results demonstrate statistically significant reductions in both neurofilament light, NfL, and glial fibrillary acidic protein, GFAP, and provide compelling evidence linking biomarker decline to improved survival. New Biomarker Analyses: Statistically significant decrease in NfL levels compared to matched ALS controls across the full analysis set in the NIH-EAP; Additional disease-relevant biomarker effects on GFAP were identified with statistically significant declines observed during the double-blind period in the HEALEY ALS Platform Trial; Among placebo-treated participants who transitioned to CNM-Au8 in the HEALEY ALS Platform Trial OLE, NfL trajectories generally showed decline or stabilization compared to increases observed during the double-blind period; NfL and GFAP biomarker decline is associated with improved survival.
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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: 3.920
Low
30.00
Averages
30.40
High
31.00
Current: 3.920
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.
See More
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.
See More
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
See More
Clene Inc. Receives FDA Approval for In-Person Meeting in 2026, NfL Reductions Linked to Lower ALS Mortality Risk
- 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.
See More
Clene Inc. Receives FDA Approval for In-Person Meeting in 2026, NfL Reduction Significantly Lowers ALS Mortality Risk
- 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, potentially paving the way for accelerated approval.
- NfL Reduction and Survival Link: In the HEALEY ALS Platform Trial, CNM-Au8 treatment resulted in approximately 10% reduction in NfL levels, significantly correlating with an 8-13% lower mortality risk, indicating potential improvement in survival expectations for ALS patients.
- IGFBP7 as a Biomarker: The study identified a decline in IGFBP7 levels associated with CNM-Au8 treatment, showing a 78% reduction in mortality risk for responders (HR 0.22, p=0.01), providing new biomarker support for ALS treatment.
- Clinical Data Support: Clene's pre-meeting briefing package includes significant reductions in NfL and GFAP, supporting NfL as a candidate biomarker for accelerated approval, which could change the future of ALS treatment.
See More
Clene Inc. Secures $28 Million Financing to Advance ALS Drug Development
- Successful Financing: Clene Inc. has completed a registered direct offering raising over $28 million, attracting top-tier investors like Boxer Capital, which is expected to fund the company into early 2027, facilitating the commercialization of its ALS drug CNM-Au8.
- Funding Allocation: The initial financing tranche exceeds $6 million, projected to sustain operations through Q3 2026, while two additional tranches totaling over $22 million are contingent on FDA approval of the New Drug Application, ensuring financial stability.
- Investor Confidence: CEO Rob Etherington noted that the investment reflects strong validation of Clene's efforts in ALS, reinforcing the promise of ALS biomarkers and survival data for the upcoming drug application.
- Market Outlook: This financing not only provides essential capital support but also enhances Clene's competitive position in the neurodegenerative disease treatment landscape, particularly in the potential commercialization opportunities within the ALS market.
See More
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.
See More
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.
See More
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
See More
Clene Inc. Receives FDA Approval for In-Person Meeting in 2026, NfL Reductions Linked to Lower ALS Mortality Risk
- 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.
See More
Clene Inc. Receives FDA Approval for In-Person Meeting in 2026, NfL Reduction Significantly Lowers ALS Mortality Risk
- 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, potentially paving the way for accelerated approval.
- NfL Reduction and Survival Link: In the HEALEY ALS Platform Trial, CNM-Au8 treatment resulted in approximately 10% reduction in NfL levels, significantly correlating with an 8-13% lower mortality risk, indicating potential improvement in survival expectations for ALS patients.
- IGFBP7 as a Biomarker: The study identified a decline in IGFBP7 levels associated with CNM-Au8 treatment, showing a 78% reduction in mortality risk for responders (HR 0.22, p=0.01), providing new biomarker support for ALS treatment.
- Clinical Data Support: Clene's pre-meeting briefing package includes significant reductions in NfL and GFAP, supporting NfL as a candidate biomarker for accelerated approval, which could change the future of ALS treatment.
See More
Clene Inc. Secures $28 Million Financing to Advance ALS Drug Development
- Successful Financing: Clene Inc. has completed a registered direct offering raising over $28 million, attracting top-tier investors like Boxer Capital, which is expected to fund the company into early 2027, facilitating the commercialization of its ALS drug CNM-Au8.
- Funding Allocation: The initial financing tranche exceeds $6 million, projected to sustain operations through Q3 2026, while two additional tranches totaling over $22 million are contingent on FDA approval of the New Drug Application, ensuring financial stability.
- Investor Confidence: CEO Rob Etherington noted that the investment reflects strong validation of Clene's efforts in ALS, reinforcing the promise of ALS biomarkers and survival data for the upcoming drug application.
- Market Outlook: This financing not only provides essential capital support but also enhances Clene's competitive position in the neurodegenerative disease treatment landscape, particularly in the potential commercialization opportunities within the ALS market.
See More
