Earnings summaries and quarterly performance for Clene.
Executive leadership at Clene.
Board of directors at Clene.
Research analysts covering Clene.
Recent press releases and 8-K filings for CLNN.
Clene Inc. granted FDA meeting for accelerated approval pathway and secures financing
CLNN
New Projects/Investments
- Clene Inc. has been granted an in-person meeting with the FDA in Q1 2026 to discuss extensive biomarker and survival data for its drug CNM-Au8, with the intention to file a New Drug Application (NDA) under the accelerated approval pathway for ALS.
- If the FDA concurs, Clene plans to file the NDA in Q2 2026, with a potential commercialization path by early 2027.
- The company recently completed a tranche financing, raising approximately $6 million at $6.50 per share, extending its cash runway by an additional quarter, with further tranches planned upon NDA acceptance and approval.
Jan 21, 2026, 8:10 PM
Clene Inc. granted FDA meeting for ALS accelerated approval pathway
CLNN
New Projects/Investments
Guidance Update
- Clene Inc. has secured an in-person meeting with the FDA this quarter to discuss extensive biomarker and survival data for its ALS treatment, CNM-Au8, with the goal of filing a New Drug Application (NDA) via the accelerated approval pathway.
- The company is presenting data to the FDA demonstrating that biomarker improvements, such as reductions in neurofilament and glial fibrillary acidic protein, are strongly associated with longer survival in ALS patients across multiple datasets.
- If the FDA agrees with the data, Clene plans to file an NDA in the second quarter of the current year, potentially leading to commercialization by early next year.
- Clene recently completed a tranche financing, raising approximately $6 million at $6.50 per share, which extends its cash runway, with additional tranches of $7 million at $7 and $15 million at $12.50 contingent on NDA acceptance and approval.
Jan 21, 2026, 8:10 PM
Clene Inc. Secures FDA Meeting for Accelerated Approval Pathway and Announces Financing
CLNN
New Projects/Investments
Guidance Update
- Clene Inc. has been granted an in-person meeting with the FDA this quarter to discuss extensive biomarker and survival data for its drug CNM-Au8, with the intention to file a New Drug Application (NDA) for accelerated approval in ALS.
- The company anticipates filing the NDA in the second quarter of the current year (2026), with a potential answer by summer and commercialization by the top of next year (2027) if accepted.
- Clene recently secured approximately $6 million in tranche financing at $6.50 per share, extending its cash runway by an additional quarter. This financing includes potential future tranches of $7 million at $7 and $15 million at $12.50 upon approval, aiming to provide funding through approval.
Jan 21, 2026, 8:10 PM
Clene Inc. announces registered direct offering of over $28 million
CLNN
New Projects/Investments
- Clene Inc. announced a registered direct offering of over $28 million.
- The offering includes the sale of 928,333 shares of common stock and accompanying warrants at $6.50 per unit, generating $6.03 million in initial gross proceeds.
- The offering also involves Series A Warrants to purchase up to 1,114,000 common shares and Series B Warrants to purchase up to 2,599,333 common shares, both with an initial exercise price of $6.00 per share.
- The initial financing tranche is expected to provide cash runway into the third quarter of 2026, with the full offering expected to fund the company into early 2027 for potential commercialization of CNM-Au8 in ALS.
Jan 13, 2026, 9:36 PM
Clene Announces Additional CNM-Au8 Biomarker Data Ahead of FDA Meeting
CLNN
- Clene Inc. announced additional CNM-Au8 biomarker data supporting a potential New Drug Application (NDA) filing for its treatment of neurodegenerative diseases.
- The FDA has granted Clene an in-person Type C meeting during the first quarter of 2026 to discuss these findings and potential accelerated approval pathways for CNM-Au8.
- New independent analyses demonstrate that modest (~10%) reductions in neurofilament light chain (NfL) are significantly associated with lower mortality risk in ALS, supporting NfL reduction as a candidate surrogate endpoint.
- Exploratory findings also showed that CNM-Au8 30mg was strongly associated with a 78% reduced mortality risk in the HEALEY ALS Platform Trial for responders with IGFBP7 biomarker decline.
Jan 12, 2026, 1:30 PM
Clene Announces Registered Direct Offering
CLNN
- Clene Inc. announced a registered direct offering of over $28 million, priced above market, with participation from new and existing investors including Boxer Capital Management, Coastlands Capital, and Vivo Capital.
- The initial financing tranche of $6.03 million is expected to provide cash runway into the third quarter of 2026.
- Two additional financing tranches, totaling over $22 million, are contingent on FDA NDA acceptance and approval for CNM-Au8, and are expected to provide capital into early 2027 for potential commercialization.
Jan 9, 2026, 1:30 PM
Clene Inc. and Faraday Future Intelligent Electric Inc. Provide Business Updates
CLNN
Product Launch
New Projects/Investments
Guidance Update
- Clene Inc. (CLNN) is preparing a New Drug Application (NDA) for its lead asset, CNMA-08, for neurodegenerative diseases, based on statistically significant biomarker data for neurofilament light chain and GFAP, with submission planned for the first half of 2026 and a potential commercialization decision in late 2026 or early 2027.
- Faraday Future Intelligent Electric Inc. (FFAI) has invested $3.5 billion in R&D and CapEx, holds over 600 patents, and targets a 10%-15% gross margin. The company is launching its FX Super 1 vehicle, priced at $84,000 in the UAE, with 11,000 pre-orders, and has partnered with Tesla for access to 28,000 supercharging stations in the U.S..
- FFAI expects pre-production FX Super 1 vehicles off the U.S. line within three weeks of December 10, 2025, leveraging competitive advantages such as tariff differentials for U.S. assembly, proprietary software, and an established dealership network.
Dec 10, 2025, 9:25 PM
Clene Inc. and Faraday Future Intelligent Electric Inc. Provide Business Updates
CLNN
Product Launch
New Projects/Investments
Guidance Update
- Clene Inc. (CLNN) is pursuing an accelerated approval pathway with the U.S. FDA for its lead asset, CNM-Au8, for ALS, based on recently released biomarker data (neurofilament light chain and glial fibrillary protein). The company plans to submit a New Drug Application (NDA) in the first half of 2026, with potential commercialization in the last half of 2026 or early 2027.
- The market opportunity for ALS drugs is significant due to few existing therapies; a previous drug (temporarily on market) was on track to sell nearly $400 million and had a market cap north of $2 billion, suggesting appreciable growth potential for Clene's market cap with commercialization approval.
- Faraday Future Intelligent Electric Inc. (FFAI) has invested $3.5 billion in R&D and CapEx, holding over 600 patents. Its Hanford manufacturing site has an initial capacity of 10,000 vehicles annually, expandable to 30,000, and the company targets a 10%-15% gross margin by partnering with Chinese OEMs.
- FFAI recently launched the FX Super 1 in the UAE at $84,000 and has received 11,000 pre-orders. Pre-production vehicles for the FX Super 1 are expected to come off the U.S. line in the next three weeks (from December 10, 2025).
Dec 10, 2025, 9:25 PM
Clene Nanomedicine Provides Update on CNM-Au8 for ALS and Accelerated Approval Efforts
CLNN
Product Launch
New Projects/Investments
Guidance Update
- Clene Nanomedicine is preparing an accelerated new drug application (NDA) for CNM-Au8 in ALS, following the presentation of new biomarker and survival data.
- Data from an NIH-sponsored Expanded Access Program (EAP) showed a significant reduction in neurofilament AUC across all matched ALS participants, with a stronger reduction in bulbar onset patients.
- This biomarker improvement was linked to improved survival outcomes, with CNM-Au8 demonstrating a 73% reduction in mortality risk at 12 months in the Healey ALS Platform Trial's full analysis set (p < 0.01).
- Clene has submitted a Type C meeting request to the FDA to discuss this data, with a meeting anticipated in Q1 2026, and plans to commence a confirmatory Phase 3 clinical study in 2026.
Dec 3, 2025, 1:30 PM
Clene Nanomedicine Presents Data Supporting Accelerated NDA for CNM-Au8 in ALS
CLNN
New Projects/Investments
- Clene Nanomedicine presented new data to support an accelerated new drug application (NDA) submission for CNM-Au8 in the treatment of Amyotrophic Lateral Sclerosis (ALS).
- This data addresses the FDA's request for substantiation of neurofilament light effects and confirmatory evidence of long-term survival.
- Results from the NIH Expanded Access Program demonstrated that CNM-Au8 produced a significant reduction in neurofilament AUC across all matched ALS participants, with a stronger reduction observed in bulbar onset patients. Concordant reductions were also seen in GFAP.
- Clene has submitted a Type C meeting request to the FDA to discuss the totality of this data, with the meeting anticipated in Q1 2026, and is concurrently preparing the NDA for submission.
- A Phase 3 clinical study with a survival endpoint is planned to commence in 2026.
Dec 3, 2025, 1:30 PM
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