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Investing.com - Clene Inc. (NASDAQ:CLNN), a $35.6 million market cap biotech company, has completed a Type-C meeting with the FDA regarding its CNM-Au8 treatment for amyotrophic lateral sclerosis (ALS), the company announced Tuesday. According to InvestingPro data, the company’s stock has shown strong momentum in recent months despite ongoing cash burn concerns.
The meeting focused on reaching agreement on the statistical analysis plan (SAP) to substantiate CNM-Au8’s effect on the decline in Neurofilament Light Chain (NfL) measurements compared to matched ALS controls. NfL is a biomarker shown to be predictive for survival, ALSFRS rate of decline, and additive to the ENCALS prediction model in ALS.
Clene has incorporated the FDA’s comments into a revised SAP, which has been resubmitted to the regulatory agency. The company anticipates acceptance of the revised plan this summer.
Two additional FDA meetings are scheduled for the third quarter of 2025 to discuss ALS survival data and the multiple sclerosis (MS) clinical development program, representing key upcoming catalysts for the stock. Analyst price targets range from $20 to $33, suggesting significant upside potential, while InvestingPro subscribers can access 8 additional key insights about Clene’s financial health and growth prospects.
Analysis of the NfL EAP biomarker data is planned for early fourth quarter of 2025, after which Clene intends to submit a new drug application for ALS under the accelerated approval pathway. The company’s next earnings report is scheduled for August 7, 2025, which could provide additional insights into its development progress and financial position.
In other recent news, Clene Inc. has received supportive feedback from the U.S. Food and Drug Administration (FDA) regarding its statistical analysis plan for the neurofilament light (NfL) biomarker data from its ALS Expanded Access Program. The company plans to conduct these analyses in the fourth quarter of 2025, with primary and supportive analyses focusing on nine-month and six-month treatment changes, respectively. Clene has also entered into an Equity Distribution Agreement with Canaccord Genuity LLC, allowing it to potentially raise up to $25 million through the sale of its common stock. This agreement will enable Clene to leverage equity markets for operational funding.
Additionally, Clene’s VISIONARY-MS Trial has shown promising results in multiple sclerosis (MS) patients treated with CNM-Au8, demonstrating improvements in cognition and visual function. The trial’s post hoc analyses have revealed significant enhancements in neuronal repair and remyelination, as confirmed by advanced MRI and visual assessments. H.C. Wainwright has maintained its Buy rating on Clene, with a price target of $31.00, following updates on the CNM-Au8 drug development program for ALS. The company has scheduled further FDA meetings in 2025 to discuss CNM-Au8’s long-term survival benefits and potential Phase 3 trials for MS. Clene remains on track for a potential New Drug Application submission for ALS under the accelerated approval pathway by the end of 2025.
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