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LA JOLLA, Calif. - MediciNova, Inc. (NASDAQ:MNOV), a clinical-stage biopharmaceutical company with a current market capitalization of $62 million, announced Monday it has completed patient enrollment in its Phase 2/3 clinical trial evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently not profitable.
The COMBAT-ALS trial has randomized 234 patients across two treatment arms at multiple clinical sites in the United States and Canada. The study is designed as a randomized, double-blind, placebo-controlled trial that will assess the efficacy, safety, and tolerability of MN-166 over a 12-month treatment period, followed by a 6-month open-label extension. While the company’s current ratio of 13.26 indicates strong short-term liquidity, InvestingPro analysis shows the company is quickly burning through its cash reserves.
The primary endpoint of the trial is the Combined Assessment of Function and Survival (CAFS), with secondary endpoints including ALSFRS-R score progression, muscle strength measured by hand-held dynamometry, and quality of life assessments. Top-line data are expected by the end of 2026.
MN-166 is an orally administered small molecule designed to modulate neuroinflammation and oxidative stress pathways implicated in ALS progression. The compound has received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration, as well as Orphan Designation from the European Medicines Agency.
"Completing enrollment in this Phase 2b/3 trial marks a major milestone for our MN-166 program and reflects the dedication of our clinical team and the ALS community," said Dr. Kazuko Matsuda, Chief Medical Officer of MediciNova, in the press release. The company’s overall financial health score stands at 2.18, rated as ’FAIR’ by InvestingPro, which offers 5 additional key insights about the company’s financial position.
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness, paralysis, and eventually respiratory failure. With analyst price targets ranging from $5 to $9 per share, significantly above the current trading price, investors seeking detailed valuation metrics and comprehensive analysis can access additional insights through InvestingPro.
The information in this article is based on a company press release statement.
In other recent news, MediciNova, Inc. has secured a Standby Equity Purchase Agreement (SEPA) that allows the company to access up to $30 million in common stock funding over a 36-month period. This agreement with Yorkville Advisors Global LP provides MediciNova the flexibility to sell its common stock at 97% of the market price without additional warrants. The company is not required to use the facility but may do so to support research programs and general corporate activities. Additionally, MediciNova has reported nearing the completion of patient enrollment in two significant clinical trials. The Phase 2/3 COMBAT-ALS trial is close to finalizing its randomization process, needing only a few more patients. Similarly, the Phase 2 trial for MN-001 in dyslipidemia and fatty liver disease due to type 2 diabetes is almost fully enrolled, requiring just two more participants. These developments represent important steps forward in MediciNova’s ongoing research efforts.
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