SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN), a late clinical-stage biopharmaceutical company, has announced its plan to meet with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss the development of its drug candidate CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). The meeting aims to re-evaluate Clene’s submission under the accelerated approval pathway, following initial feedback from the FDA’s Division of Neurology 1 (DN1) that the briefing package was not supportive of an NDA submission for accelerated approval.
Clene will present to the FDA’s Office on New Drugs, Office of Neuroscience, and DN1 review team, along with key opinion leaders in the field of ALS. The discussion will address questions on ALS biomarkers, clinical endpoints, and survival data, which the company believes are critical for understanding the potential of CNM-Au8.
The company has gathered over 700 patient-years of safety data for CNM-Au8, which has not shown significant safety concerns or identified serious adverse events related to the treatment. CNM-Au8 is an oral suspension of gold nanocrystals aimed at restoring neuronal health and function by enhancing energy production and utilization, targeting mitochondrial function and the NAD pathway, and reducing oxidative stress.
This announcement comes as Clene continues its research into treatments for neurodegenerative diseases, including ALS, Parkinson's disease, and multiple sclerosis. The company, headquartered in Salt Lake City with R&D and manufacturing operations in Maryland, emphasizes its commitment to improving mitochondrial health and protecting neuronal function as a means to treat these conditions.
The outcome of the forthcoming meeting with the FDA could be a significant step for Clene in its efforts to bring CNM-Au8 to patients with ALS. Investors and stakeholders in the neurodegenerative disease treatment space will be watching closely for the results of this engagement. This article is based on a press release statement from Clene Inc.
In other recent news, Clene Inc. has been the subject of several significant developments. The biopharmaceutical company recently received a Buy rating from both EF Hutton and H.C. Wainwright, with price targets set at $23.00 and $31.00 respectively. EF Hutton's rating was based on Clene's innovative approach to treating neurodegenerative conditions, while H.C. Wainwright raised their target after Clene released promising new biomarker data for their drug CNM-Au8.
In addition to the analyst ratings, Clene also announced a 1-for-20 reverse stock split, reducing the outstanding common stock from approximately 128.7 million shares to about 6.4 million shares. This strategic move aims to maintain compliance with Nasdaq's minimum bid price requirement for continued listing.
Furthermore, Clene's investigational drug CNM-Au8 has shown promising results in treating amyotrophic lateral sclerosis (ALS) and Rett Syndrome. The drug's efficacy was supported by new data submitted to the U.S. Food and Drug Administration (FDA), including results from Phase 2 clinical trials. The company's ongoing efforts to explore new indications for CNM-Au8 highlight its commitment to addressing unmet medical needs in neurodegenerative diseases.
InvestingPro Insights
As Clene Inc. (NASDAQ:CLNN) prepares for its crucial meeting with the FDA to discuss the future of CNM-Au8, its ALS drug candidate, the company's financial health and market performance become particularly relevant for investors monitoring the situation. According to real-time metrics from InvestingPro, Clene's market capitalization stands at approximately $43.61 million. The company's revenue for the last twelve months as of Q2 2024 was reported at $0.44 million, indicating a decline of 43.62% compared to the previous period.
InvestingPro Tips highlight that Clene is experiencing a significant cash burn, which is a crucial factor for investors considering the company's long-term viability. Additionally, analysts have revised their earnings upwards for the upcoming period, suggesting a potential optimism about the company's financial prospects following the FDA meeting.
Despite the challenges, Clene has shown a strong return over the last month, with a 30.87% increase in its stock price. This performance, however, is set against a backdrop of analysts not anticipating profitability for the company this year, coupled with a lack of dividend payments to shareholders. For investors seeking a deeper understanding of Clene's financial and market position, InvestingPro offers additional tips, with a total of 9 insights available at: https://www.investing.com/pro/CLNN.
These insights could provide valuable context as stakeholders assess Clene's potential in the neurodegenerative treatment market and the implications of the upcoming FDA meeting for the company's drug development trajectory.
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