For the first time in decades, scientific progress, regulatory innovation, and policy momentum are aligning for ALS.
A new @iamals op-ed highlights why this moment matters for people living with ALS and their families.
Read the article here: https://t.co/tQvGVcoqRH
Today, June 2, we recognize Lou Gehrig Day and stand with everyone impacted by ALS.
As a company, we honor Lou Gehrig’s legacy of courage and support continued awareness, care, and research for the ALS community.
#LouGehrigDay#ALSawareness#EndALS
Late-breaking #ECTRIMS2025 data: CNM-Au8® improved brain energy metabolism (↑NAD+/NADH ratio) in MS & Parkinson’s patients.
FDA now open to endpoints beyond EDSS, incl. cognition.
More: https://t.co/YXDP5yzpnh
#MS#Neurodegeneration#CNMAu8
The Clene Team joined @iamalsorg on the National Mall, where a sea of blue flags honors lives lost to ALS.
We stand with families and support reauthorization of ACT for ALS to advance awareness, research, care, and a cure. 💙
#EndALS#ACTforALS
Clene has received FDA support to pursue an accelerated approval NDA for CNM-Au8® in ALS. Clene plans to submit the NDA in the third quarter of 2026, representing a potential first-in-class therapeutic approach for ALS.
Read more: https://t.co/CZtKhMSm9U
Want the latest on Clene’s CNM-Au8® Expanded Access Program for ALS?
Join us March 12 at 5 PM ET for a live webinar with Dr. Jinsy Andrews and the Clene Inc. team.
Hosted by the Sean M. Healey & AMG Center for ALS.
Register: https://t.co/xQ8vwP8muu
Could biomarkers help reveal treatment response in ALS?
On Monday, March 9th at the @MDAorg Clinical & Scientific Conference, Marjan Sepassi of Clene will present a poster on IGFBP7 as a nexus biomarker using data from CNM-Au8® during and after the HEALEY ALS Platform Trial.
🧬 New ALS biomarker insights.
Marjan Sepassi, VP of Medical Affairs at Clene, will present a poster on Monday, Mar 9th at the @MDAorg Clinical & Scientific Conference
“IGFBP7 as a Nexus Biomarker Identifying a Coordinated Treatment Response Phenotype in ALS”
#ALS#Biomarkers
Happening today (5–6 PM ET) Join the NEALS webinar:
CNM-Au8® in ALS: NIH Expanded Access Program (EAP) Clinical & Biomarker Update
Q&A with Michael Hotchkin (Clene) and Benjamin Greenberg, MD (UT Southwestern/Clene).
Register Here: https://t.co/qLFBdYw2Hl
#ALS#NEALS#Webinar
Join us for an upcoming NEALS webinar on Wednesday, February 25, 2026, from 5–6 PM ET:
CNM-Au8® in ALS: NIH Expanded Access Program (EAP) Clinical & Biomarker Update
Don’t miss this important clinical and biomarker update
Register here: https://t.co/qLFBdYw2Hl
#ALS#NEALS
Exploratory HEALEY analyses showed that responders with IGFBP7 decline on CNM-Au8 had a 78% lower mortality risk (HR 0.22, p=0.01), supporting IGFBP7 as a potential biomarker of response.
PR: https://t.co/WgxuQnpk1o
Clene’s data align with the FDA’s accelerated approval framework in ALS, linking reproducible NfL reductions with CNM-Au8 to improved survival across independent datasets.
Independent ALS cohort analyses show that ~10% NfL reductions are linked to lower mortality risk, supporting NfL as a potential surrogate endpoint for accelerated approval.
PR: https://t.co/WgxuQnpk1o
Clene has been granted an in-person FDA Type C meeting in Q1 2026 to discuss CNM-Au8® and emerging biomarker data in ALS, including NfL as a potential surrogate endpoint.
PR: https://t.co/WgxuQnpRQW
Happy Holidays from all of us at Clene!
We’re grateful for 2025 progress on CNM-Au8® in ALS and excited to gear up for our FDA Type C meeting in Q1 2026 as we advance toward an accelerated approval pathway.
#ALS#Biotech#Neurodegeneration#Innovation
Happy Holidays from all of us at Clene!
We’re grateful for 2025 progress on CNM-Au8® in ALS and excited to gear up for our FDA Type C meeting in Q1 2026 as we advance toward an accelerated approval pathway.
#ALS#Biotech#Neurodegeneration#Innovation
ICYMI: FDA-recommended analyses show CNM-Au8® produced statistically significant reductions in NfL & GFAP
Participants with the largest declines in both biomarkers saw the greatest long-term survival benefit, an ~80% reduced risk of death vs. controls
PR:https://t.co/tWXEpN4VNf
Thank you @iamalsorg for highlighting new CNM-Au8® biomarker data from the ACT for ALS Expanded Access Program.
These findings offer meaningful insight into survival and the importance of real-world data in ALS research.
Read More: https://t.co/XxilIA7cuq
Thank you @iamalsorg for highlighting new CNM-Au8® biomarker data from the ACT for ALS Expanded Access Program.
These findings offer meaningful insight into survival and the importance of real-world data in ALS research.
Read More: https://t.co/XxilIA7cuq