Clene Inc. CLNN Archives - Page 2 of 9

FridayFeb 28, 2025 11:00 am

Clene Inc. (NASDAQ: CLNN) Leverages APST’s NfL Database to Support FDA-Recommended Analyses for ALS Drug

Clene is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8® in ALS patients. APST maintains one of the largest ALS biomarker databases, with data from over 4,300 ALS patients, including clinical outcomes and biomarker tracking. The analysis will compare NfL changes in the NIH-sponsored Expanded Access Program (“EAP”) participants with historical ALS patient data to assess CNM-Au8’s potential efficacy. Clene plans to submit its statistical analysis plan to the FDA, aiming for filing of an NDA for potential accelerated approval in the second half of 2025. No significant safety concerns have been reported…

ThursdayFeb 27, 2025 10:55 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) CEO and CFO to Present at Investor Summit Virtual on March 11

Clene (NASDAQ: CLNN) announced that CEO Rob Etherington and CFO Morgan Brown will present at the Investor Summit Virtual on March 11, 2025. The event will provide investors with insights into the company’s latest developments and strategic outlook. To view the full press release, visit https://ibn.fm/NzQFl About Clene Inc. Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system…

TuesdayFeb 25, 2025 9:30 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Partners with APST Research to Advance ALS Drug Approval Process

Clene (NASDAQ: CLNN) has entered into an agreement with Germany-based APST Research GmbH to utilize its extensive neurofilament light chain (NfL) database in FDA-recommended analyses of CNM-Au8® for treating amyotrophic lateral sclerosis (ALS). APST's repository includes biomarker data from over 4,300 ALS patients, which will help Clene compare NfL changes in NIH-sponsored Expanded Access Protocol participants to matched controls. The results could support Clene’s planned New Drug Application submission for CNM-Au8 under the FDA's Accelerated Approval pathway in the second half of 2025. CEO Rob Etherington emphasized the importance of leveraging real-world evidence to advance potential treatments for ALS. To view…

WednesdayJan 08, 2025 2:22 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Paves Cash Runway to Advance CNM-Au8(R) for ALS

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). The company recently secured a new $10 million debt facility, which enables the payoff of another higher interest rate loan and the finance of operations to generate additional data to support the new drug application of lead drug candidate CNM-Au8 for ALS. “We believe that the proceeds from this new debt facility, including an extended interest-only period, will allow Clene the cash…

ThursdayDec 26, 2024 2:43 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Receives FDA Roadmap on Potential Accelerated Pathway for CNM-Au8(R)

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with…

ThursdayDec 26, 2024 10:15 am

Clene Inc. (NASDAQ: CLNN) Improves Cash Position and Runway with New Debt Facility for CNM-Au8(R) Data Collection to Support Accelerated Approval Application

The $10 million loan agreement, carrying a 12% interest rate and secured by all assets of Clene, was signed with three lenders affiliated with the company. The funds will be used to repay the remaining $7.9 million debt of an Avenue Capital Group loan, and will improve the company’s cash position, enabling it extra runway to generate additional data to support the new drug application of CNM-Au8 for ALS. The FDA earlier suggested that Clene leverage additional neurofilament light (“NfL”) data from the company’s three Expanded Access Protocols (compassionate use programs) and the HEALEY ALS Platform Trial to support earlier…

FridayDec 13, 2024 12:15 pm

Clene Inc. (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Pathway for CNM-Au8(R) for ALS

The FDA asked for additional Neurofilament Light (“NfL”) data from the company’s three Expanded Access Protocols to support earlier clinical trial findings. The company has already begun collecting and analyzing this data, with plans to complete the process in Q2 2025 and then submit a New Drug Application (“NDA”) for CNM-Au8 by mid-2025. A follow-up meeting with the FDA will be held early next year to discuss and finalize the statistical analysis plan for the EAP NfL biomarker analyses. The company is meanwhile preparing a confirmatory Phase 3 trial (“RESTORE-ALS”) to evaluate the survival benefit of CNM-Au8 with initial participant…

ThursdayOct 24, 2024 1:05 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Set to Discuss Lead Candidate Biomarker with FDA Leadership

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently announced an upcoming meeting with U.S. Food and Drug Administration (“FDA”) leadership. The focus is to discuss Clene’s CNM-Au8® biomarker and related clinical and survival data for ALS. “FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (‘DN1’) review team, as well as recognized key opinion leaders in ALS,…

FridayOct 18, 2024 12:00 pm

Clene Inc. (NASDAQ: CLNN) Presents Lead Candidate CNM-Au8(R) Updates, Latest Achievements at Top Investor Conferences

Clene gave a fireside presentation and held one-on-one investor meetings at the 2024 Maxim Healthcare Virtual Summit on October 15. On October 30, Clene will give a presentation and participate in one-on-one meetings at The ThinkEquity Conference 2024 at the Mandarin Oriental Hotel in New York. Clene’s lead drug candidate, CNM-Au8® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions. Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS and is scheduled to have a meeting with the FDA leadership in November. Clene (NASDAQ: CLNN) and its…

ThursdayOct 10, 2024 11:15 am

Clene Inc. (NASDAQ: CLNN) Closes $7.3 Million Registered Direct Offering and Concurrent Private Placements

Proceeds from the offerings will support the company’s operations into the first quarter of 2025. Clene also amended its existing debt facility with Avenue Venture Opportunities Fund, L.P. to reduce or defer future monthly principal payments and to extend principal amortization period and the final maturity date into the first half of 2025. The company’s lead drug candidate, CNM-Au8® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions. Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS, with a meeting scheduled with the FDA before the end…

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