Welcome to our dedicated page for Clene news (Ticker: CLNN), a resource for investors and traders seeking the latest updates and insights on Clene stock.
Clene Inc. (Nasdaq: CLNN) generates a steady stream of news as a late clinical-stage biopharmaceutical company focused on neurodegenerative and neurological diseases. Company updates frequently center on its lead investigational therapy CNM-Au8, an oral suspension of gold nanocrystals designed to improve mitochondrial function, brain energy metabolism, and neuronal resilience in conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease (PD).
Investors and followers of CLNN news can expect detailed announcements on clinical trial results, biomarker analyses, and regulatory interactions. In ALS, Clene has reported statistically significant reductions in biomarkers like neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) with CNM-Au8 treatment, along with analyses linking biomarker changes to survival outcomes. News releases also cover FDA-recommended analyses, Type C meeting requests and outcomes, and the company’s plans for a potential New Drug Application under the accelerated approval pathway.
For MS and PD, Clene’s news includes Phase 2 data from REPAIR-MS and REPAIR-PD, where CNM-Au8 improved the brain NAD+/NADH ratio and related measures of energy metabolism, as well as preclinical PD data on mitochondrial health and cellular function. The company also issues regular financial and corporate updates, including quarterly results, equity distribution activity, convertible note agreements, and registered direct offerings that support its development and regulatory programs.
This CLNN news page aggregates these disclosures, from scientific conference presentations and investor webcasts to financing announcements and SEC-related communications. Readers who track Clene’s progress can use this feed to follow the evolution of CNM-Au8 across ALS, MS, and PD, monitor key regulatory milestones, and understand how new biomarker and survival data shape the company’s development strategy.
Clene (Nasdaq: CLNN)/b) priced an underwritten registered direct offering of at $7.00 per share, for gross proceeds of approximately $7.0 million. The offering is expected to close on or about May 6, 2026, subject to customary closing conditions.
Proceeds are expected to fund NDA preparation for CNM-Au8, continued access and a future confirmatory Phase 3 trial, manufacturing expansion, potential commercialization efforts, and early-stage R&D. Canaccord Genuity is sole bookrunner; the offering is made under an effective Form S-3 shelf registration.
Clene (Nasdaq: CLNN) will participate in two investor events in early May 2026: a virtual Emerging Growth Conference presentation on May 6, 2026 at 3:25 p.m. ET and one-on-one meetings at the D. Boral Capital Global Conference on May 7, 2026 at The Plaza Hotel, New York.
Presentation access is available via a webcast link and investor meetings are scheduled as 1x1 sessions.
Clene (Nasdaq: CLNN) received final FDA minutes confirming the agency believes Clene’s proposed data may support an NDA submission under the Subpart H accelerated approval pathway for CNM-Au8 in ALS. The FDA said NfL could potentially serve as a reasonably likely surrogate endpoint and requested additional data linking NfL reductions to clinical benefit. Clene expects to submit an NDA in Q3 2026 and plans a Phase 3 confirmatory study to start in Q1 2027. CNM-Au8 holds prior Orphan Drug designation for ALS.
Clene (Nasdaq: CLNN) reported full-year 2025 results and operational updates on CNM-Au8. Key items: a Type C face-to-face FDA meeting expected by end of Q1 2026, a planned NDA filing by end of June 2026, an oversubscribed registered direct offering of >$28M, and $5.2M cash as of 12/31/2025.
R&D was $14.0M and G&A $9.2M for 2025; net loss narrowed to $26.2M ($2.65/share) from $39.4M in 2024.
Clene (Nasdaq: CLNN) outlined 2026 catalysts for CNM-Au8, including a planned NDA submission in Q2 2026 via an accelerated pathway and a potential PDUFA date in H2 2026. The company reports operating runway into Q4 2026 after a registered direct offering and plans a confirmatory Phase 3 RESTORE-ALS trial dosing later in 2026.
Clene cites >800 patients treated, >1,000 patient-years of exposure, biomarker declines (NfL, GFAP), favorable safety, and additional financing tranches tied to regulatory milestones.
Clene (Nasdaq: CLNN) will present a corporate update at the Emerging Growth Conference on February 25, 2026 at 1:45 p.m. ET. The presentation will be virtual and available live via webcast and later as a replay on the conference portal and YouTube.
The webcast can be accessed through Clene's Events page or by registering at the conference webcast link; a replay will be posted after the event.
Clene (Nasdaq: CLNN) management will present a corporate update at the Emerging Growth Conference on January 21, 2026 at 3:10 p.m. ET. The presentation is virtual and will be webcast; live access is available via registration at the provided webcast link and from the Events section of the Clene website. A replay will be available after the event through the conference portal and the Emerging Growth YouTube channel. The conference hosts video webcasts in Eastern Time and targets individual and institutional investors, advisors, and analysts.
Clene (Nasdaq: CLNN) announced the FDA granted an in-person Type C meeting in Q1 2026 to discuss biomarker-driven pathways for CNM-Au8. The company submitted a briefing package linking ~9–10% NfL reductions observed in HEALEY and NIH EAP studies to an 8–13% lower mortality risk across large ALS cohorts, and reported a HEALEY long-term survival benefit for CNM-Au8 30 mg (HR 0.272, 95% CI 0.096–0.772, p=0.014; 93% alive at 12 months). Exploratory IGFBP7 findings showed a 78% mortality risk reduction in responders (HR 0.22, p=0.012). Results are presented as candidate surrogate biomarker evidence and require prospective confirmation.
Clene (Nasdaq: CLNN) announced a registered direct offering of approximately $28 million on January 9, 2026, led by Boxer Capital, Coastlands Capital and Vivo Capital. An initial tranche sold 928,333 common shares with warrants at $6.50 per unit, raising about $6.03 million expected to fund operations into Q3 2026. Two additional warrant-linked tranches totaling roughly $22 million are contingent on NDA acceptance and FDA approval for CNM-Au8 in ALS. Series A and Series B warrants are exercisable immediately with tiered exercise-price increases tied to PDUFA and FDA approval announcements. BTIG is sole placement agent; closing expected on or about Jan 12, 2026.
Clene (Nasdaq: CLNN) announced management will present a corporate update at the Emerging Growth Conference on December 10, 2025 at 4:25 p.m. ET. The presentation will be virtual and a live webcast will be available on the company Events page and through the conference portal. A replay will be posted on the Emerging Growth YouTube channel after the event. The presentation covers company developments related to Clene's clinical-stage programs in neurodegenerative diseases including ALS and MS.