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MediciNova to Participate at the 38th Annual ROTH Conference
Globenewswire· 2026-03-16 11:00
LA JOLLA, Calif., March 16, 2026 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), announces that Yuichi Iwaki, M.D., Ph.D., President and CEO, and David H. Crean, Ph.D., Chief Business Officer will participate at the 38th Annual ROTH Conference. The conference is being held on March 22 – 24, 2026 at The Ritz-Carlton Laguna Niguel in Dana Point, CA. Drs. ...
MediciNova(MNOV) - 2025 Q4 - Annual Report
2026-03-10 21:15
Financial Performance - The company reported significant operating losses and does not expect to generate any revenues from product sales for the foreseeable future[20]. - The company anticipates fluctuations in its quarterly or annual operating results, which could impact investor confidence[19]. Product Development and Regulatory Challenges - The company is heavily reliant on the success of its product candidates MN-166 (ibudilast) and MN-001 (tipelukast) for future growth[20]. - The complexity and high costs associated with obtaining regulatory approval for product candidates are significant challenges[22]. - The company faces uncertainties in completing clinical trials and obtaining regulatory approvals in a timely manner[15]. - There are risks associated with potential undesirable side effects of product candidates that could delay or prevent regulatory approval[22]. - The company has not yet achieved market acceptance for its product candidates, which may affect future revenues[19]. Capital and Operational Risks - There are known risks related to the inability to raise additional capital, which could impact business operations[15]. - The company is dependent on third parties for conducting clinical trials and manufacturing product candidates[15]. - The company is subject to strict government regulations that could affect its business operations and product development[19].
MediciNova(MNOV) - 2025 Q4 - Annual Results
2026-02-20 11:25
Exhibit 99.1 February 20, 2026 Unaudited Consolidated Financial Results for the Fiscal Year Ended December 31, 2025 (Under U.S. GAAP) | Company name: | Medicinova, Inc. | | | --- | --- | --- | | Listing: | Tokyo Stock Exchange | | | Securities code: 4875 | | | | URL: | https://medicinova.jp | | | Representative: | Yuichi Iwaki, Representative Director, President and CEO | | | Inquiries: | Kazuko Matsuda, Director and CMO, Vice President, Representative of the Tokyo Office | | | Telephone: | +81-3-5532-5912 ...
MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN‑166 (ibudilast) in ALS patients
Globenewswire· 2026-01-29 23:00
Core Insights - MediciNova, Inc. has achieved significant progress in its SEANOBI study for MN-166 (ibudilast), with 100 patients enrolled, representing 50% of the target enrollment of 200 patients [1][2] - The SEANOBI Expanded-Access Program is funded by a $22 million grant from NINDS under the ACT for ALS initiative, aimed at providing treatment access to ALS patients not eligible for clinical trials while collecting valuable clinical data [2][4] - MN-166 is also being evaluated in the COMBAT-ALS Phase 2b/3 trial, with top-line results expected by the end of 2026 [3][5] SEANOBI Study - The SEANOBI study is designed to evaluate MN-166 in ALS patients and aims to enroll approximately 200 patients across 12 active sites [4] - The program focuses on generating real-world clinical outcomes and biomarker data, including neurofilament levels, to support future regulatory discussions [2][4] COMBAT-ALS Trial - The COMBAT-ALS trial is a randomized, placebo-controlled study assessing the efficacy and safety of MN-166, with 234 patients enrolled in the U.S. and Canada [3][5] - The trial includes a 12-month double-blind period followed by a 6-month open-label extension, with results anticipated by the end of 2026 [3][5] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a late-stage pipeline including MN-166 and MN-001 [8] - MN-166 has received Orphan Drug Designation from the FDA and EMA, as well as Fast Track Designation from the FDA for ALS treatment [7][8]
2026 New Year’s Greetings from the CEO
Globenewswire· 2026-01-06 14:00
Core Insights - MediciNova, Inc. has navigated a challenging 2025 marked by global uncertainty, achieving significant milestones including the completion of patient enrollment in three clinical trials and launching a large-scale Expanded Access Program for ALS [1] Clinical Development Highlights - MN-001 (tipelukast) Phase 2 trial for hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and Type 2 diabetes (T2DM) completed enrollment in November 2025, with top-line data expected in summer 2026 [3] - The COMBAT-ALS Study Phase 2b/3 trial for ALS completed enrollment in September 2025, with top-line results anticipated by year-end 2026 [7] - The Expanded Access Program for ALS, initiated in March 2025 with a $22 million NIH grant, has 12 active U.S. sites and 87 patients enrolled as of December 15, 2025 [7] - The OXTOX Study Phase 2b trial for chemotherapy-induced peripheral neuropathy in metastatic colon cancer completed enrollment in December 2025, with results timing yet to be determined [7] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a strong pipeline based on MN-166 (ibudilast) and MN-001 (tipelukast) [5] - MN-166 is currently in Phase 3 for ALS and degenerative cervical myelopathy, and is Phase 3-ready for progressive multiple sclerosis [5]
After-Hours Biotech Rally: Inspira, MediciNova, DiaMedica Therapeutics Among Gainers
RTTNews· 2025-12-19 04:27
Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]
MediciNova Announces Completion of Patient Enrollment Evaluating MN-166 (ibudilast) in the Prevention of Chemotherapy-induced Peripheral Neuropathy
Globenewswire· 2025-12-18 11:00
Core Insights - MediciNova, Inc. has successfully completed patient enrollment in the Phase 2 clinical trial, OXTOX study, evaluating MN-166 (ibudilast) for preventing chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [1][2] Group 1: Clinical Trial Details - The OXTOX study is a randomized, placebo-controlled trial with 100 patients enrolled across 11 clinical sites in Australia [1] - Participants will continue chemotherapy along with either MN-166 or placebo until disease progression or unacceptable side effects, with the study concluding when the final patient reaches six months post-chemotherapy [2] Group 2: About MN-166 (ibudilast) - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for various neurodegenerative diseases, including ALS and progressive MS [3] - The compound has Orphan Drug Designation and Fast Track Status from the US FDA for ALS, and Orphan Drug Designation from the EMA [3] Group 3: About MediciNova - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [4] - The company has a strong pipeline, with MN-166 in Phase 3 for ALS and DCM, and MN-001 (tipelukast) in Phase 2 for treating hypertriglyceridemia in type 2 diabetic patients [4]
MediciNova Announces Update and Basic Characteristic Randomized Patients' of Phase 2/3 Clinical Trial of MN-166 (Ibudilast) in ALS (COMBAT-ALS Clinical Trial) Presented at the 36th International Symposium on ALS/MND
Globenewswire· 2025-12-08 11:00
Core Insights - MediciNova, Inc. has provided an update on its Phase 2b/3 clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS), known as the COMBAT-ALS study, with results presented at the 36th International Symposium on ALS/MND [1][2] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a late-stage pipeline including MN-166 (ibudilast) and MN-001 (tipelukast) [4][6] Clinical Trial Update - The COMBAT-ALS trial has successfully randomized a total of 234 participants, completing enrollment in September 2025 [5] - The baseline characteristics of participants include a mean age of 60.6 years, with 36.8% female and 63.2% male, and a racial distribution predominantly Caucasian (90.2%) [5] - The mean ALSFRS-R score at screening was 40.6, indicating the severity of the disease among participants [5] Drug Development and Designation - MN-166 (ibudilast) has received Orphan Drug Designation and Fast Track Designation from the FDA, as well as Orphan Designation from the European Commission for ALS treatment [3][2] - The drug is also in late-stage development for other neurodegenerative diseases and conditions, including progressive multiple sclerosis and glioblastoma [3][4] Future Expectations - Top-line data from the COMBAT-ALS study is anticipated by the end of 2026, with the company expressing hope that MN-166 will provide a significant therapeutic advance for ALS patients [2]
Message from the CEO to MediciNova Shareholders
Globenewswire· 2025-12-01 23:00
Core Insights - The recent study published in the Journal of Atherosclerosis and Thrombosis highlights a novel mechanism by which MN-002, the primary metabolite of MN-001, enhances cholesterol efflux in macrophages, crucial for combating atherosclerosis and cardiovascular disease [1][2] - MN-001 shows potential in addressing multiple metabolic disorders, including hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes (T2DM), due to its multi-modal activity and strong safety profile [2][3] Clinical Progress and Future Steps - Patient enrollment for the Phase 2 trial (MN-001-NATG-202) in patients with hypertriglyceridemia and NAFLD due to T2DM has been completed, with top-line results expected by summer 2026 [3] - The combination of newly published mechanistic findings and upcoming trial results will guide the advancement of MN-001 as a potential first-in-class therapy for metabolic and cardiovascular diseases [3] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a strong pipeline including MN-166 (ibudilast) and MN-001 (tipelukast) [4]
MediciNova Appoints Dr. Christopher Breder, MD, PhD as Clinical and Regulatory Advisor
Globenewswire· 2025-11-18 11:00
Core Insights - MediciNova, Inc. has appointed Dr. Christopher D. Breder as Clinical and Regulatory Advisor to enhance its drug development programs and lead the Scientific Advisory Board [1][4] - Dr. Breder brings over two decades of experience, including significant roles at the FDA and contributions to the approval of therapies for neurological conditions [2][3] - The company is focused on developing innovative therapies for neurodegenerative diseases, with a strong pipeline including MN-166 and MN-001 [5] Company Overview - MediciNova is a clinical-stage biopharmaceutical company with a late-stage pipeline targeting inflammatory, fibrotic, and neurodegenerative diseases [5] - The lead asset, MN-166 (ibudilast), is in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is ready for Phase 3 for progressive multiple sclerosis (MS) [5] - MN-001 (tipelukast) is currently in a Phase 2 trial for treating hypertriglyceridemia in type 2 diabetic patients [5] Leadership and Strategy - Dr. Breder's expertise in clinical trial design and regulatory strategy positions him to effectively guide MediciNova in advancing its pipeline [3] - The company aims to combine rigorous science with patient-centered design to accelerate meaningful outcomes in neurodegenerative disease therapies [4]