2026 New Year's Greetings from the CEO
MWN-AI** Summary
In his New Year’s greeting to shareholders, MediciNova, Inc. CEO Yuichi Iwaki reflected on the significant achievements of 2025 despite global challenges, including inflation, changes in U.S. trade policies, and geopolitical tensions. The company made notable strides, completing patient enrollment in three key clinical trials and launching an Expanded Access Program for Amyotrophic Lateral Sclerosis (ALS).
The highlights included the completion of enrollment in the Phase 2b/3 COMBAT-ALS study for MN-166 (ibudilast) in September 2025, with top-line results anticipated by year-end. A successful outcome could lead to regulatory submission, positioning MediciNova for further advancements. Additionally, the company initiated a noteworthy Expanded Access Program for ALS in March, thanks to a $22 million NIH grant, which saw rapid enrollment across 12 U.S. sites.
Moreover, the OXTOX Phase 2b study for chemotherapy-induced peripheral neuropathy enrollment was concluded in December, with optimistic expectations for future results. Similarly, the MN-001 (tipelukast) Phase 2 trial for hypertriglyceridemia and Type 2 diabetes reported completed enrollment in November 2025, with data expected in summer 2026. Iwaki emphasized the importance of a recent academic collaboration that uncovered new insights into MN-001's impact on cholesterol and lipid metabolism, further solidifying its development path.
Looking ahead to 2026, Iwaki expressed optimism about achieving the company’s goals and reiterated MediciNova's commitment to delivering better treatments for serious diseases. He concluded with wishes for a prosperous New Year for all stakeholders as the company enters a pivotal year in its journey.
MWN-AI** Analysis
MediciNova, Inc.’s recent New Year's letter from CEO Yuichi Iwaki paints a cautiously optimistic picture for shareholders as we head into 2026. The completion of enrollment in key clinical trials, particularly the COMBAT-ALS study for MN-166 (ibudilast), which targets ALS, positions the company at a crucial inflection point. Expected top-line results later this year could significantly influence stock performance, especially if the data supports a regulatory submission.
The expansion of the ALS Expanded Access Program, underpinned by NIH grant support, is another strong indication of the company's commitment to innovative healthcare solutions. This initiative not only highlights MediciNova’s potential to impact patient care positively but also demonstrates credibility in securing funding for clinical trials, an essential factor for biotech companies.
Investors should closely monitor the anticipated results for both MN-166 and MN-001 (tipelukast), particularly in addressing hypertriglyceridemia, NAFLD, and Type 2 diabetes. Positive outcomes could lead to increased investor confidence and a solid foundation for future capital raises, which are crucial given stated funding risks.
However, potential investors must remain aware of inherent risks, including regulatory hurdles and trial uncertainties. The market’s response to the upcoming data releases will likely be volatile, given the high stakes involved in clinical trial outcomes.
In conclusion, while MediciNova demonstrates a robust pipeline and has overcome significant challenges thus far, the volatility typically associated with clinical-stage biopharmaceutical stocks warrants a measured, watchful approach. Investors considering entry or additional positions should weigh the potential upside against the substantial risks, maintaining a diversified portfolio to mitigate exposure to sector-specific uncertainties.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
LA JOLLA, Calif., Jan. 06, 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) provides shareholders a corporate update in the following Letter to Stockholders from CEO Yuichi Iwaki, M.D., Ph.D.
Dear Fellow Shareholders,
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.
Clinical Development Highlights
MN-166 (ibudilast)
- COMBAT-ALS Study Phase 2b/3 trial for Amyotrophic Lateral Sclerosis (ALS): Enrollment was completed in September 2025. Data analysis will begin after the last participant completes the 12-month double-blind treatment period, with top-line results expected by year-end. Positive results would enable regulatory submission, and preparations for that stage are already underway.
- 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 (CIPN) in metastatic colon cancer: Enrollment was completed in December 2025. Participants will continue treatment until disease progression or other discontinuation criteria. Timing for results remains to be determined, but MediciNova is optimistic about advancing this program.
MN-001 (tipelukast)
- MN-001-NATG-202 Study Phase 2 trial for hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and Type 2 diabetes (T2DM): 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.
I sincerely wish you all a year filled with happiness and success.
Yuichi Iwaki
President & CEO
MediciNova, Inc.
January 2026
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 numerous 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-001 (tipelukast) is in a Phase 2 trial treating hypertriglyceridemia in type 2 diabetic patients. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Forward-Looking Statements
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.
Investor Contact:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
FAQ**
Given the potential regulatory submission for MN-166 (ibudilast) following the upcoming results, how does MediciNova Inc. MNOV plan to address potential market competition in ALS treatment post-approval?
What financing strategies is MediciNova Inc. MNOV considering to ensure sufficient capital for ongoing trials and operations, especially with the risks associated with future partner funding?
How does the collaboration revealing a novel mechanism for MN-001 impact MediciNova Inc. MNOV's long-term development strategy and commercialization plans for treating hypertriglyceridemia and related conditions?
With the completion of patient enrollment in the COMBAT-ALS and OXTOX studies, what contingency plans does MediciNova Inc. MNOV have in place to manage potential delays in data analysis or regulatory approval processes?
**MWN-AI FAQ is based on asking OpenAI questions about MediciNova Inc. (NASDAQ: MNOV).
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