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MediciNova Announces Poster Presentation of COMBAT-ALS Clinical Trial at the 36th International Symposium on ALS/MND

Key Takeaway: MediciNova, Inc. announced that an abstract for the Phase 2b/3 COMBAT clinical trial of MN-166 (ibudilast) in ALS patients will be presented at the 36th International Symposium on ALS/MND. The presentation will cover trial updates and baseline characteristics, showcasing the company's ongoing commitment to addressing neurodegenerative diseases. The event is scheduled for December 5-7, 2025, in San Diego, CA.
Price reaction · baseline $1.24 (2025-09-15 close) · hit pre-market · clean, no other MNOV news in the window
day 0 close
+0.8%

Market Sentiment Analysis

POSITIVE FACTORS

  • MN-166 (ibudilast) shows promise in treating ALS and other neurodegenerative diseases.
  • The upcoming presentation at a major symposium highlights the trial's significance.
  • MediciNova has a strong pipeline with multiple programs in clinical development.

CONCERNS & RISKS

  • Risks associated with obtaining future funding for clinical development.
  • Uncertainties inherent in clinical trials may affect outcomes.
  • Potential delays in regulatory approvals could impact timelines.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~39 mo
Minimal dilution risk
Lead asset
MN-001
Phase 2 · Diabetes Mellitus, Type 2

Full Press Release Details

LA JOLLA, Calif., Sept. 16, 2025 (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), today announced that an abstract regarding the Phase 2b/3 COMBAT clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients has been selected for a poster presentation at 36thInternational Symposium on ALS/MND to be held December 5-7, 2025 in San Diego, CA.
The presentation details are as follows:

Paper Number: 228

Title:COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Baseline Characteristics

Theme: Clinical Trial and Trial Design

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Frequently Asked Questions

What is the COMBAT-ALS clinical trial?

The COMBAT-ALS trial is a Phase 2b/3 study evaluating MN-166 (ibudilast) in ALS patients.

When will the COMBAT-ALS trial results be presented?

Results will be presented at the 36th International Symposium on ALS/MND from December 5-7, 2025.

What is MN-166 (ibudilast) used for?

MN-166 is being developed for ALS and other neurodegenerative diseases, including MS.

What are the risks mentioned in the announcement?

Risks include funding uncertainties and potential delays in clinical trial outcomes.

Last updated: Sep 16, 2025