Clene Touts FDA Path for ALS Drug CNM-Au8, Highlights Biomarkers, Extends Cash Runway [Yahoo! Finance]
Clene Inc. (CLNN)
Company Research
Source: Yahoo! Finance
the end of March and is targeting an NDA submission by end of Q2 , with outcomes ranging from direct NDA acceptance to a request for a Phase III trial. Management highlighted a statistically significant neurofilament benefit in the double-blind Phase II HEALEY trial—CNM-Au8 was the only program of eight to show a pre-specified neurofilament difference—and presented corroborating GFAP biomarker changes that tracked with neurofilament and were associated with improved survival in responder analyses (notable risk reductions reported across several analyses). Clene raised $6M (at $6.50) to fund near-term regulatory work and expects runway into Q4, with contingent financings of $7M on NDA filing/acceptance and $13M on approval that could extend cash into 2027; the company also reiterated CNM-Au8 activity in multiple sclerosis but said Phase III MS funding would likely require ALS commercialization proceeds or a partner. Interested in Clene Inc.? Here are five stocks we like better.
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CLNN
News
- Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 CatalystsGlobeNewswire
- Clene to Present at the Emerging Growth Conference [Yahoo! Finance]Yahoo! Finance
- Clene to Present at the Emerging Growth ConferenceGlobeNewswire
- Clene to Present at the Emerging Growth ConferenceGlobeNewswire
- Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA MeetingGlobeNewswire
CLNN
Sec Filings
- 2/24/26 - Form 8-K
- 2/20/26 - Form 4
- 2/20/26 - Form 4
- CLNN's page on the SEC website