MediciNova CEO Updates Shareholders, Looks Ahead to 2026
MediciNova provides shareholders a corporate update in the following Letter to Stockholders from CEO Yuichi Iwaki, M.D., Ph.D. "The year 2025 was marked by global uncertainty, with accelerating inflation, evolving U.S. trade policies under the new administration, and persistent geopolitical risks. Despite these challenges, MediciNova achieved significant milestones, including completion of patient enrollment in three clinical trials and the launch of a large-scale Expanded Access Program for ALS... COMBAT-ALS Study Phase 2b/3 trial for Amyotrophic Lateral Sclerosis (ALS): Enrollment was completed in September 2025... Expanded Access Program for ALS: Initiated in March 2025 with support from a $22 million NIH research grant. As of December 15, 2025, 12 U.S. sites were active and 87 patients enrolled. OXTOX Study Phase 2b investigator-initiated trial for chemotherapy-induced peripheral neuropathy in metastatic colon cancer: Enrollment was completed in December 2025.... MN-001-NATG-202 Study Phase 2 trial for hypertriglyceridemia, non-alcoholic fatty liver disease, and Type 2 diabetes: Enrollment was completed in November 2025. Top-line data are anticipated in summer 2026. Recent academic collaboration revealed a novel mechanism by which MN-001 and its metabolite MN-002 impact cholesterol and lipid metabolism, reinforcing the compound's development strategy. Looking ahead, 2026 will be a pivotal year for MediciNova-a year when we can finally reach the goals we have been striving toward. We will strengthen our commitment and work as one team to deliver better treatments to patients suffering from serious diseases."
Get Free Real-Time Notifications for Any Stock
Analyst Views on MNOV
About MNOV
About the author
MediciNova Activates SEANOBI Study with 100 Patient Enrollments
- Patient Enrollment Progress: As of the end of January 2026, MediciNova has successfully enrolled 100 ALS patients across 12 sites in the U.S., achieving 50% of the planned 200 enrollments, marking significant progress in the clinical development of MN-166 and potentially accelerating the drug approval process.
- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
Biotech Surge Post-Market: Inspira, MediciNova, and DiaMedica Therapeutics Among Top Performers
Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
