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Investing.com - H.C. Wainwright has reiterated its Buy rating and $31.00 price target on Clene , Inc. (NASDAQ:CLNN), representing significant upside from the current price of $3.91. The bullish stance comes as the company updates its CNM-Au8 drug development program for amyotrophic lateral sclerosis (ALS). According to InvestingPro data, analyst targets range from $20 to $33, with a strong consensus Buy recommendation.
The company reported on June 30 that it had completed a Type C meeting with the FDA to discuss the statistical analysis plan for neurofilament light (NfL) biomarker data from its ongoing NIH-sponsored Expanded Access Protocol. Based on FDA feedback, Clene plans to include NfL changes following nine months of treatment as the primary analysis, with six-month treatment changes serving as supportive analysis. While the company maintains a current ratio of 1.36, InvestingPro analysis indicates the company is quickly burning through cash, a critical factor for investors monitoring drug development progress.
The biotech firm expects acceptance of its statistical analysis plan this summer, with biomarker analyses planned for the fourth quarter of 2025. If results demonstrate clinically meaningful NfL decline, they could support a New Drug Application for CNM-Au8 in ALS under the accelerated approval pathway by the end of 2025.
Clene has scheduled two additional FDA meetings in the third quarter of 2025 to review CNM-Au8’s long-term survival benefits compared to controls from another HEALEY ALS Platform Trial regimen, and to discuss results from its Phase 2 VISIONARY-MS clinical trial and potential Phase 3 study in multiple sclerosis.
The company’s upcoming milestones include an ALS survival data Type C meeting and MS end-of-Phase 2 Type B meeting in the third quarter of 2025, ALS biomarker analyses in the fourth quarter, and a potential Accelerated Approval NDA submission in ALS by year-end 2025. With a market capitalization of $35.12 million and several key catalysts ahead, investors seeking deeper insights into Clene’s financial health and growth prospects can access additional analysis and 8 more exclusive ProTips on InvestingPro.
In other recent news, Clene Inc. reported receiving supportive feedback from the U.S. Food and Drug Administration regarding its statistical analysis plan for neurofilament light biomarker data in its ongoing ALS program. The company plans to conduct these analyses in the fourth quarter of 2025, comparing data from ALS patients receiving CNM-Au8 to matched controls. Clene is preparing for potential submission of a new drug application for ALS by the end of 2025, depending on the analysis outcomes. Additionally, Clene entered into an Equity Distribution Agreement with Canaccord Genuity LLC, allowing the company to offer and sell up to $25 million of its common stock. This agreement aims to provide Clene with the flexibility to raise capital as needed. Furthermore, Clene announced findings from its VISIONARY-MS trial, showing improvements in multiple sclerosis patients treated with CNM-Au8. These improvements included remyelination and neuronal repair, as evidenced by advanced MRI and visual assessments. The company is optimistic about verifying these results in a forthcoming global Phase 3 trial.
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