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. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
Clene (Nasdaq: CLNN) reported first quarter 2026 results and key regulatory advances for CNM-Au8 in ALS. Following a successful FDA Type C meeting, the FDA indicated the proposed data may support an NDA under the accelerated approval pathway, and Clene plans NDA submission in Q3 2026 and a confirmatory Phase 3 trial in Q1 2027.
Clene completed an oversubscribed $28M registered direct offering in January 2026, a $7M underwritten registered direct in May, and amended a $10M convertible debt facility. Q1 2026 net loss was $8.1M ($0.69/share), with cash of $5.9M and runway projected into Q4 2026, potentially into 2027 with warrant exercises.
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.