Medicinova Stock Price, News & Analysis

MediciNova (NASDAQ:MNOV) has completed patient enrollment in its Phase 2b/3 COMBAT-ALS clinical trial evaluating MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) treatment. The study has successfully randomized 234 patients across sites in the United States and Canada.

The trial is designed as a randomized, double-blind, placebo-controlled study with a 12-month treatment period followed by a 6-month open-label extension. The primary endpoint focuses on the Combined Assessment of Function and Survival (CAFS), with top-line data expected by end of 2026.

MN-166 has received Orphan Drug and Fast Track Designations from the FDA and Orphan Designation from the EMA, having shown promising results in earlier studies.

MediciNova (NASDAQ:MNOV) announced that its Phase 2b/3 COMBAT-ALS clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients will be featured in a poster presentation at the 36th International Symposium on ALS/MND. The symposium will take place from December 5-7, 2025 in San Diego, CA.

The presentation, titled "COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Baseline Characteristics," has been assigned Paper Number 228 and falls under the Clinical Trial and Trial Design theme.

MediciNova (NASDAQ: MNOV) announced two significant developments. First, the company secured a Standby Equity Purchase Agreement (SEPA) worth up to $30 million over 36 months, with shares priced at 97% of market value. The SEPA proceeds will support R&D programs and corporate activities.

Second, MediciNova achieved its target enrollment in the COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). The company is also running an Expanded Access Program supported by a $22 million NIH grant. Additionally, patient enrollment is nearly complete for their Phase 2 trial of MN-001 in hypertriglyceridemia and fatty liver disease.

MediciNova (NASDAQ:MNOV) has announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference, scheduled for September 8-10, 2025, at the Lotte New York Palace Hotel. President and CEO Yuichi Iwaki, MD., Ph.D., and Chief Business Officer David H. Crean, PhD will deliver a corporate overview presentation.

The presentation will be available on-demand starting at 7:00 AM ET on September 5, 2025. Investors can access the live webcast through MediciNova's investor relations website, with the replay remaining available for approximately 90 days. The executives will also be available for one-on-one meetings during the conference.

MediciNova (NASDAQ:MNOV) has announced the successful completion of target enrollment in its Phase 2b/3 COMBAT-ALS clinical trial for MN-166 (ibudilast), a drug candidate being developed for Amyotrophic Lateral Sclerosis (ALS) treatment.

The multi-site trial, conducted across the United States and Canada, represents a crucial milestone in MN-166's development program. According to CEO Dr. Yuichi Iwaki, this achievement reflects strong collaboration between clinical sites, investigators, and patient communities, bringing the company closer to evaluating MN-166's potential impact on ALS patients.

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.