Welcome to our dedicated page for Medicinova news (Ticker: MNOV), a resource for investors and traders seeking the latest updates and insights on Medicinova stock.
Medicinova, Inc. (NASDAQ: MNOV), headquartered in La Jolla, California, is a clinical-stage biopharmaceutical company focused on acquiring and developing promising small-molecule therapeutics to treat diseases with unmet medical needs. Specializing in therapies for neurological disorders and fibrotic diseases, Medicinova has a strategic emphasis on the U.S. market.
Medicinova’s robust product portfolio includes several innovative drugs in late-stage clinical development. These include MN-001 (tipelukast) and MN-166 (ibudilast), both of which boast multiple mechanisms of action and strong safety profiles. MN-166 (ibudilast) is in Phase 3 clinical trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is Phase 3-ready for progressive multiple sclerosis (MS). It is also being evaluated in Phase 2 trials for Long COVID, substance dependence, and other neurodegenerative diseases.
The company recently received a series of new patents, significantly extending its intellectual property protection. One such patent covers the use of MN-166 for treating macular injury and decreasing macular volume loss associated with progressive multiple sclerosis. Another patent covers the formulation of MN-166 in extended-release oral forms, which is expected to improve patient compliance and reduce side effects.
Medicinova has demonstrated the potential of MN-166 in ophthalmic neurodegenerative diseases, supported by positive data from various animal model studies and the SPRINT-MS Phase 2b trial. Additionally, MN-166 is under investigation for its efficacy in treating glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy (CIPN), and substance use disorder.
Alongside its development efforts, Medicinova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. This financial support underscores the promise and potential of its therapies to address critical medical needs.
For more information or investor inquiries, please contact Geoff O'Brien, Vice President at info@medicinova.com.
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.
MediciNova (NASDAQ:MNOV) has announced its support for an NIH-funded Expanded Access Protocol (EAP) trial to evaluate MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS). The NIH-NINDS has awarded $22 million for this intermediate-size trial, which will allow 200 ALS patients who are ineligible for the ongoing COMBAT-ALS trial to receive treatment with MN-166.
MediciNova will provide the investigational drug, regulatory support, and safety monitoring. The trial will evaluate neurofilament light, a biomarker for neuron damage, and clinical data. This initiative is supported by the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), signed into law by President Biden.
MediciNova, Inc. (NASDAQ:MNOV) has announced that an abstract regarding the COMBAT-ALS clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) treatment has been accepted for poster presentation at the 35th International Symposium on ALS / MND. The symposium will take place from December 6-8, 2024, in Montreal, Canada.
The presentation, titled 'COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results', will be delivered by lead Principal Investigator Dr. Björn Oskarsson, Associate Professor of Neurology and Director of ALS Center of Excellence at Jacksonville, FL. The abstract has been assigned Paper Number 302 and falls under the theme of Clinical Trial and Trial Design.
MediciNova (NASDAQ:MNOV) announced the acceptance of an abstract for presentation at the 2024 Annual NEALS Meeting regarding their COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS). The poster presentation, titled 'COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update,' will be delivered by lead Principal Investigator Dr. Björn Oskarsson on October 23rd, 2024. The NEALS Meeting, a hybrid event, will take place from October 21-24, 2024, in Clearwater, Florida, and online. This presentation represents an important milestone in MediciNova's ALS research and development efforts.
MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering MN-166 (ibudilast) for post-COVID conditions. The Method of Use patent covers administering ibudilast to alleviate various post-COVID symptoms, including anxiety, fatigue, depression, and shortness of breath. The patent allows for multiple administration methods and dosing regimens, either alone or in combination with other active agents.
The patent is expected to expire no earlier than November 2042, providing extended exclusivity for MediciNova. The company is currently conducting a Phase 2/3 clinical trial in Long COVID in collaboration with University Health Network in Canada. MediciNova plans to initiate discussions with Health Canada for a New Drug Application if the RECLAIM study shows positive results.
MediciNova, a biopharmaceutical company listed on NASDAQ (MNOV) and Tokyo Stock Exchange, announces that David H. Crean, Ph.D., its Chief Business Officer, will now oversee investor engagement and public relations. Dr. Crean aims to enhance communication channels, providing stakeholders with clearer insights into the company’s vision and strategy. MediciNova plans to increase transparency through regular updates on milestones and achievements, hoping to attract new investors. CEO Yuichi Iwaki highlighted the company's active programs in neurodegeneration and other independently run projects that are expected to generate additional cash flow upon regulatory approvals. The company acknowledges a previous disconnect in market communication and is committed to improving clarity under Dr. Crean's leadership.
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