MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN‑166 (ibudilast) in ALS patients

Rhea-AI Summary

MediciNova (NASDAQ:MNOV) announced that as of January 2026, 100 patients have been enrolled in the NIH‑funded SEANOBI Expanded‑Access Program (EAP) evaluating MN‑166 (ibudilast) in ALS, representing 50% of the planned 200 enrollment across 12 activated US sites. The program is supported by a $22 million NINDS grant under ACT for ALS and will generate real‑world biomarker and clinical outcome data alongside the COMBAT‑ALS Phase 2b/3 randomized trial (234 patients enrolled; topline expected by end of 2026).

Positive

• Enrollment reached 100 patients (50% of planned 200)
• $22 million NINDS grant funds SEANOBI expanded access
• 12 US sites activated to deliver MN‑166 in real‑world settings
• COMBAT‑ALS has 234 patients enrolled; topline results by end 2026

Negative

• SEANOBI data are from expanded‑access, uncontrolled patients and lack randomized comparison

Market Reaction

+4.00% $1.82

15m delay 1 alert

+4.00% Since News

$1.82 Last Price

$1.70 $1.82 Day Range

+$3M Valuation Impact

$86M Market Cap

0.5x Rel. Volume

Following this news, MNOV has gained 4.00%, reflecting a moderate positive market reaction. The stock is currently trading at $1.82. This price movement has added approximately $3M to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

SEANOBI sites: 12 sites SEANOBI enrollment: 100 patients Planned SEANOBI enrollment: 200 patients +5 more

8 metrics

SEANOBI sites 12 sites Activated U.S. sites in SEANOBI Expanded-Access Program

SEANOBI enrollment 100 patients Enrolled in SEANOBI Expanded-Access Program for ALS

Planned SEANOBI enrollment 200 patients Planned total enrollment; current 100 represents 50%

NINDS grant $22 million NIH/NINDS funding under ACT for ALS supporting SEANOBI EAP

COMBAT-ALS enrollment 234 patients Enrolled in COMBAT-ALS Phase 2b/3 trial in U.S. and Canada

Double-blind duration 12 months COMBAT-ALS randomized double-blind treatment period

Open-label extension 6 months COMBAT-ALS open-label extension following double-blind period

Top-line timing End of 2026 Expected timing for COMBAT-ALS top-line results

Market Reality Check

Price: $1.75 Vol: Volume 50,551 is below th...

low vol

$1.75 Last Close

Volume Volume 50,551 is below the 20-day average of 96,060 (rel. volume 0.53). low

Technical Price $1.75 is trading above the 200-day MA of $1.38 and 15.05% below the 52-week high of $2.06.

Peers on Argus

MNOV was down 2.23% while notable peers such as ANL appeared in momentum scanner...

1 Up

MNOV was down 2.23% while notable peers such as ANL appeared in momentum scanners with large upside moves and others like APLT were also positive, indicating today’s action in MNOV looked more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	CEO strategic update	Positive	+0.0%	CEO outlined 2025 trial completions and 2026 milestones for MN-166 and MN-001.
Dec 18	Clinical enrollment complete	Positive	-1.4%	Completion of Phase 2 OXTOX enrollment in neuropathy prevention with 100 patients randomized.
Dec 08	ALS trial update	Positive	-3.2%	COMBAT-ALS Phase 2b/3 baseline characteristics and enrollment completion presented at symposium.
Dec 01	Pipeline and trial update	Positive	-2.8%	Peer-reviewed MN-002 data and completion of Phase 2 MN-001 enrollment in metabolic disease.
Nov 18	Advisory appointment	Positive	+2.1%	Appointment of clinical and regulatory advisor with extensive FDA and neuromuscular experience.

Pattern Detected

Recent fundamentally positive updates on MN-166 and MN-001 often saw flat to modestly negative next-day moves, with only the advisor appointment drawing a clear positive reaction.

Recent Company History

Over the last few months, MediciNova has highlighted steady clinical execution across MN‑166 and MN‑001. Updates included completion of enrollment in the COMBAT‑ALS and OXTOX trials, progress in metabolic indications, and strategic advisory appointments. Several of these developments, despite being operationally positive, saw flat or negative 24h price reactions. Today’s SEANOBI enrollment milestone builds directly on the CEO’s Jan 6, 2026 letter, which previously disclosed early EAP progress and framed 2026 as pivotal for ALS data.

Market Pulse Summary

This announcement highlights tangible progress in MediciNova’s ALS programs, with the SEANOBI expand...

Analysis

This announcement highlights tangible progress in MediciNova’s ALS programs, with the SEANOBI expanded-access study reaching 100 of a planned 200 patients and the COMBAT‑ALS Phase 2b/3 trial fully enrolled at 234 patients. Together, these studies are expected to generate both clinical and real‑world evidence, with top-line COMBAT‑ALS data anticipated by end of 2026. Investors may track future updates on enrollment completion, biomarker findings, and regulatory interactions tied to these programs.

Key Terms

orphan drug designation, fast track designation, phase 2b/3, placebo-controlled, +2 more

6 terms

orphan drug designation regulatory

"along with having Orphan Drug Designation from FDA and EMA and Fast Track Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track designation regulatory

"Orphan Drug Designation from FDA and EMA and Fast Track Designation from FDA"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

phase 2b/3 medical

"COMBAT‑ALS Phase 2b/3 trial, a randomized, placebo‑controlled study"

A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.

placebo-controlled medical

"COMBAT‑ALS Phase 2b/3 trial, a randomized, placebo‑controlled study assessing MN‑166’s efficacy"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

biomarkers medical

"Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

open-label extension medical

"includes a 12‑month double‑blind period followed by a 6‑month open‑label extension"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

AI-generated analysis. Not financial advice.

LA JOLLA, Calif., Jan. 29, 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), today announced that as of the end of January 2026, 12 sites in the US are activated and 100 patients have been enrolled in the SEANOBI study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS; NCT 06743776) representing 50% of the planned 200-enrollment, evaluating MN‑166 (ibudilast) in patients with amyotrophic lateral sclerosis (ALS).

Dr. Yuichi Iwaki, President and CEO of MediciNova, commented: “Achieving 100 enrolled patients in the NIH‑funded SEANOBI Expanded‑Access Program marks substantial progress in the clinical development of MN‑166. We are deeply grateful to the patients and families who chose to participate in SEANOBI, as their commitment makes this important program possible. We also sincerely appreciate the continued support from NINDS under the ACT for ALS initiative, which has enabled to expand access to MN‑166 while gathering meaningful clinical and biomarker insights. Together with our COMBAT‑ALS study, SEANOBI brings forward both clinical and real‑world evidence that will support discussions with regulators. We believe these combined data along with having Orphan Drug Designation from FDA and EMA and Fast Track Designation from FDA, will help us advance MN‑166 one step closer to becoming an approved treatment option for people living with ALS, who urgently need more choices.”

The NIH‑funded SEANOBI Expanded‑Access Program (EAP), supported by a $22 million NINDS grant under ACT for ALS, is designed to offer MN-166 (ibudilast) treatment access to individuals living with ALS who are not eligible to participate in ongoing randomized clinical trials. while also generating important biomarker and clinical outcome data from a real‑world ALS population.

MN‑166 (ibudilast) is also being evaluated in the COMBAT‑ALS Phase 2b/3 trial, a randomized, placebo‑controlled study assessing MN‑166’s efficacy and safety in ALS. The study includes a 12‑month double‑blind period followed by a 6‑month open‑label extension, with 234 patients enrolled in the U.S. and Canada. Top‑line results are expected by the end of 2026.

About SEANOBI-ALS

The SEANOBI Expanded‑Access Program (EAP) is a U.S.‑based initiative funded by a $22 million NINDS/NIH grant under ACT for ALS, designed to provide MN‑166 (ibudilast) to individuals living with ALS who are not eligible for ongoing randomized clinical trials. The program aims to enroll approximately 200 patients across 12 active sites and is structured to collect valuable real‑world clinical outcomes and biomarker data, including neurofilament levels.

About COMBAT‑ALS

COMBAT‑ALS is MediciNova’s ongoing Phase 2b/3 randomized, double‑blind, placebo‑controlled clinical trial evaluating the efficacy, safety, and tolerability of MN‑166 (ibudilast) in individuals with amyotrophic lateral sclerosis. A total of 234 patients have been randomized across clinical sites in the United States and Canada. The study includes a 12‑month double‑blind treatment period, followed by a 6‑month open‑label extension. Top‑line results are expected by the end of 2026. COMBAT‑ALS is designed to generate the controlled‑trial evidence necessary to support MN‑166’s potential future approval for the treatment of ALS.

References

https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-awarded-federal-grant-to-study-experimental-als-drug/

https://www.ninds.nih.gov/news-events/directors-messages/all-directors-messages/updates-act-als

https://investors.medicinova.com/news-releases/news-release-details/medicinova-support-nih-funded-expanded-access-clinical-trial

About MN-166 (ibudilast)

MN-166 (ibudilast) is an orally available 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). MediciNova holds Orphan Drug Designation for MN-166 (ibudilast) in ALS by U.S. FDA and EU EMA. MN-166 (ibudilast) has received Fast Track Designation by FDA for treatment of ALS. In addition, MN-166 (ibudilast) holds Orphan Disease Designation for the treatment of Glioblastoma.

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.

INVESTOR CONTACT:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com

FAQ

How many patients has MediciNova (MNOV) enrolled in the SEANOBI EAP as of January 29, 2026?

MediciNova reports 100 patients enrolled as of January 2026, which is 50% of the planned 200-enrollment. According to MediciNova, enrollment occurred across 12 activated US sites under the NIH‑funded SEANOBI EAP.

What funding supports the SEANOBI expanded‑access program for MN‑166 (MNOV)?

The SEANOBI EAP is supported by a $22 million NINDS grant under ACT for ALS. According to MediciNova, the NIH funding enables expanded treatment access while collecting biomarker and clinical outcome data.

How does SEANOBI relate to MediciNova's COMBAT‑ALS trial (MNOV)?

SEANOBI provides real‑world and biomarker data complementary to COMBAT‑ALS's randomized results. According to MediciNova, combined evidence from SEANOBI and COMBAT‑ALS will inform regulatory discussions.

What is the enrollment and timeline for COMBAT‑ALS mentioned by MediciNova (MNOV)?

MediciNova states COMBAT‑ALS has 234 patients enrolled in the U.S. and Canada with topline results expected by end of 2026. The trial includes a 12‑month double‑blind period plus a 6‑month open‑label extension.

Does SEANOBI include patients who could not join randomized ALS trials for MN‑166 (MNOV)?

Yes. According to MediciNova, SEANOBI is designed to offer MN‑166 to individuals not eligible for ongoing randomized trials while generating biomarker and clinical outcome data from a real‑world ALS population.