Clene Inc. CLNN Archives - Page 2 of 9

FridayMar 07, 2025 1:29 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Collaborates to Support Potential Accelerated Pathway for ALS Treatment Candidate

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data in evaluating its drug candidate, CNM-Au8®, for ALS treatment. Based in Germany, APST operates one of the largest ALS biomarker repositories, which includes data from over 4,300 ALS patients. This collaboration will enable Clene to compare NfL levels in patients treated with CNM-Au8 against historical ALS controls to assess the drug’s potential in slowing disease progression. The goal is to use these findings to support FDA accelerated approval for CNM-Au8 by demonstrating its ability to reduce NfL…

ThursdayMar 06, 2025 8:55 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) to Participate in 37th Annual Roth Conference

Clene (NASDAQ: CLNN) a late clinical-stage biopharmaceutical company developing treatments for neurodegenerative diseases such as ALS and MS, announced its participation in the 37th Annual Roth Conference. Management will host a virtual fireside chat on March 18, 2025, at 9:20 a.m. PST and conduct one-on-one investor meetings. Interested parties are encouraged to contact their Roth representative for scheduling. To view the full press release, visit https://ibn.fm/qjx1W 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…

WednesdayMar 05, 2025 10:45 am

Clene Inc. (NASDAQ: CLNN) to Highlight Latest Achievements, Next Steps for CNM-Au8(R), at Q1 Virtual Investor Summit on March 11

The Q1 Virtual Investor Summit will focus on microcap companies that are undervalued, and aim to create connections between leading investors and microcap companies Clene’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown Clene’s participation in the event comes as the company is moving closer to submitting a New Drug Application to the FDA to secure potential accelerated approval for CNM-Au8® for ALS The company recently partnered with German-based APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8 efficacy in ALS patients. Clene Inc. (NASDAQ: CLNN) and its wholly owned subsidiary, Clene…

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…

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