Latest Clene Inc. News & Updates

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Clene Inc. (Clene)

Clinical-stage biopharmaceutical company developing nanotherapeutics for neurodegenerative diseases

clene.com

Headquarters: SALT LAKE CITY, United States
Founded year: 2013
Company type: Public company
Number of employees: 70–200
Industry: Pharmaceuticals

Last updated October 19

Latest news about Clene Inc. (Clene)

In short: Clene advanced toward a Q4 2026 FDA NDA filing for ALS drug CNM-Au8, backed by biomarker data, legislation, and fresh financing.

Company announcements

October 19 Clene

Clene submits NDA to FDA for CNM-Au8 ALS treatment

Seeking accelerated approval based on biomarker data and clinical outcomes while continuing Phase 3 RESTORE-ALS study preparations.

September 15 Clene

Clene announces four million dollar registered direct offering

The capital funds operations through mid-2027 to support CNM-Au8 development and manufacturing expansion.

August 14 Clene

Clene reports second quarter 2026 financial results

The company expects to submit an NDA for CNM-Au8 in ALS under the accelerated approval pathway in early Q4 2026, with new biomarker data showing survival and functional benefit.

August 6 Clene

Clene announces biomarker analyses supporting ALS accelerated approval

CNM-Au8-treated patients with NfL decline or stabilization showed significant survival and functional benefits versus controls in Phase 2 trials.

Media coverage

October 19 Markets Insider

Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomesSALT LAKE CITY, Oct.

October 2 Yahoo Finance

Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision

Clene (NASDAQ:CLNN) said it plans to submit a new drug application to the U.S. Food and Drug...

September 15 Yahoo Finance

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders$4...

August 19 Yahoo Finance

Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses

Clene (NASDAQ:CLNN) is preparing to submit a New Drug Application, or NDA, seeking accelerated...

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