Clene Nanomedicine

Clene is committed to revolutionizing the treatment for people living with neurodegenerative diseases to restore and protect neuronal health.

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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 Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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.

[Clene Nanomedicine @CleneNano]

🧬 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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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 Nanomedicine @CleneNano]

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.

[Clene Nanomedicine @CleneNano]

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 Nanomedicine @CleneNano]

As we prepare for our FDA Type C meeting, follow Clene for updates on CNM-Au8® and our ongoing regulatory discussions in ALS.

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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

[Clene Nanomedicine @CleneNano]

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