Medicinova Stock Price, News & Analysis

MediciNova (NASDAQ:MNOV) has entered into a Standby Equity Purchase Agreement (SEPA) worth up to $30 million with Yorkville Advisors Global LP. The 36-month agreement allows MediciNova to sell common stock at 97% of market price, with individual transactions limited to 100% of the 5-day trading volume.

The funds will support R&D programs and general corporate activities. The agreement notably excludes warrants, providing flexibility to capitalize on favorable market conditions. According to CEO Dr. Yuichi Iwaki, while the company maintains a strong cash position, the SEPA offers additional capital access options for R&D initiatives and strategic opportunities.

MediciNova (NASDAQ:MNOV) reported significant progress in two key clinical trials. The Phase 2/3 COMBAT-ALS trial for MN-166 (ibudilast) is now down to single-digit patient enrollment requirements. Additionally, their Phase 2 trial studying MN-001 (tipelukast) for dyslipidemia and fatty liver disease in type 2 diabetes patients needs only two more participants.

The company's ALS program includes a large Expanded Access Program (EAP) supported by a $22 million NIH grant. MediciNova expects to engage in FDA regulatory discussions and anticipates top-line data by the end of 2026.

MediciNova (NASDAQ: MNOV) has announced its participation in the upcoming Inaugural DBC Conference organized by D. Boral Capital on May 14, 2025 at the Plaza Hotel, New York City.

The company's leadership team, including CEO Dr. Yuichi Iwaki and CBO Dr. David H. Crean, will engage in investor meetings during the conference. They will present MediciNova's leading programs focused on neurologic and metabologic disorders.

The conference will facilitate interactions between public and private executives and various investor groups, including institutional investors, high-net worth individuals, and corporate clients, with a particular focus on Healthcare & Life Sciences sectors.

MediciNova (NASDAQ:MNOV) has announced the enrollment of the first patient in an NIH-funded Expanded Access Program (EAP) trial evaluating MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients. The trial aims to provide access to MN-166 for ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial.

The EAP trial, funded by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), will assess the safety and efficacy of MN-166 in approximately 200 ALS patients. This initiative specifically targets individuals in advanced stages of ALS who cannot participate in the current Phase 2/3 COMBAT-ALS trial.

MediciNova (NASDAQ:MNOV) presented interim analysis results from its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS at the 35th International Symposium on ALS/MND. The study has enrolled 217 participants, with 183 assigned to treatment or placebo groups as of November 15, 2024.

The interim analysis revealed positive correlations between 6-month and 12-month data for various metrics: CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). Strong correlations were also observed in Bulbar (0.74), Fine motor (0.71), and Gross motor scores (0.67). The Data Safety Monitoring Board recommended continuing the trial as planned.

Patient assignments are expected to complete by June 2025, with trial results anticipated in 2026. The company is also supporting continued treatment through FDA's Expanded Access Program.

MediciNova's CEO Yuichi Iwaki provided a corporate update highlighting the company's strategy of partnering with institutions and government agencies to conduct clinical trials while preserving capital. The company announced a collaboration for an NIH-funded Phase 2-3 ALS Expanded Access study of MN166 (ibudilast), running parallel to their COMBAT-ALS trial. The company maintains $42.3 million in cash as of September 30, 2024, and expects additional non-dilutive funding from a Sanofi/Novartis settlement. Other ongoing partnerships include a Health Canada-funded Long COVID trial and various programs with U.S. government agencies, where MediciNova primarily provides study drug and administrative support.

MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the USPTO for a new patent covering MN-001 (Tipelukast) for decreasing triglyceride synthesis in the liver. The patent application covers a method of administering MN-001 or its metabolite to subjects with insulin resistance, pre-diabetes, or diabetes. The patent, expected to expire no earlier than May 26, 2042, includes claims for various formulations and administration methods. The compound can be administered orally with flexible dosing frequencies.

MediciNova (NASDAQ: MNOV) announced it will receive monetary damages following the settlement of Sanofi-Novartis litigation. The company plans to use this non-dilutive funding to support ongoing clinical development programs, particularly focusing on their late-stage pipeline targeting inflammatory, metabolic, and neurodegenerative diseases. The settlement validates MediciNova's intellectual property value and strengthens their financial position as they advance their novel small molecule therapies towards commercialization.

MediciNova (NASDAQ:MNOV) provided an update on its ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients at the 2024 Annual NEALS Meeting. Lead Principal Investigator Dr. Björn Oskarsson presented details about the COMBAT-ALS trial, including the study design, objectives, and major inclusion criteria. The presentation also covered enrollment updates as of October 18, 2024, and discussed a new NIH-funded Expanded Access Protocol clinical trial in ALS patients.