MediciNova Reports Patient Data from 234 in ALS Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
0mins
Should l Buy MNOV?
Source: Newsfilter
- Clinical Trial Progress: MediciNova has completed randomization of 234 patients in its COMBAT-ALS study for ALS, overcoming challenges posed by the COVID-19 pandemic to finalize enrollment by September 2025, demonstrating resilience in clinical research.
- Patient Demographics: Among participants, 36.8% were female and 63.2% male, with a mean age of 60.6 years, and the racial distribution aligns with other ALS trials, supporting the generalizability of the study findings.
- ALS Scoring Data: The average ALSFRS-R score at screening was 40.6, with a mean disease duration of 12.5 months, providing a crucial baseline for subsequent efficacy assessments.
- Future Outlook: MediciNova anticipates top-line data by the end of 2026, and if MN-166 proves effective, it could represent a significant therapeutic advance for ALS patients, further propelling the company's growth in the neurodegenerative disease sector.
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Analyst Views on MNOV
Wall Street analysts forecast MNOV stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MNOV is 11.00 USD with a low forecast of 11.00 USD and a high forecast of 11.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.620
Low
11.00
Averages
11.00
High
11.00
Current: 1.620
Low
11.00
Averages
11.00
High
11.00
About MNOV
MediciNova, Inc. is a biopharmaceutical company that is developing therapeutics with a primary focus on neurology, respiratory and liver diseases. The Company's development activities are focused on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (methamphetamine dependence, opioid dependence and alcohol dependence), prevention of acute respiratory distress syndrome, and Long COVID, and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease and hypertriglyceridemia. Its MN-166 (ibudilast) is a first-in-class, oral, anti-inflammatory and neuroprotective agent. The FDA has granted Fast Track designations to MN-166 (ibudilast) for three separate indications: progressive MS, ALS, and methamphetamine dependence.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Study Progress: MediciNova's SEANOBI study has enrolled 50% of its target 200 participants, indicating significant clinical research advancement in ALS, which may provide new treatment options for patients.
- Funding Support: The study is backed by a $22 million NIH grant aimed at accelerating access to therapies for ALS patients, reflecting government commitment to this research area and confidence in MediciNova.
- Clinical Trials: The ongoing COMBAT ALS trial for MN-166 has enrolled 234 patients, with top-line results expected by the end of 2026, which will provide critical efficacy data that could influence future market performance.
- Drug Development: In addition to ALS, MN-166 is being developed for glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy, and substance use disorder, showcasing its broad potential indications that could diversify the company's revenue streams.
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- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
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- Study Design: This randomized, placebo-controlled Phase 2 trial allows participants to continue chemotherapy while receiving either MN-166 or a placebo, with the study expected to conclude six months post-chemotherapy, providing critical efficacy data for future development.
- Future Data Expectations: While the exact completion date is not yet determined, top-line data is anticipated to be available later in 2026, which will provide essential insights for MN-166's further development and could significantly impact its market prospects.
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See More
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- Study Design: This randomized, placebo-controlled Phase 2 clinical trial aims to evaluate the efficacy of MN-166 (ibudilast) in chemotherapy patients, which is expected to provide critical data for future treatment options.
- Data Expectations: While the exact completion date of the study is not yet determined, top-line data is anticipated to be available in 2026, which will support further development and market potential for MN-166.
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- Patient Demographics: Among participants, 36.8% were female and 63.2% male, with a mean age of 60.6 years and a racial distribution of 90.2% Caucasian, aligning with other ALS trials and enhancing the generalizability of the study findings.
- Drug Development Support: MediciNova is actively supporting patients wishing to continue MN-166 treatment through the FDA’s Individual Patient Expanded Access Program, demonstrating the company's commitment to ALS patients, with MN-166 receiving Orphan Drug and Fast Track Designation.
- Future Development Plans: The company is closely collaborating with experienced regulatory experts to prepare for the next steps in advancing MN-166, aiming to address uncertainties and risks in clinical trials to ensure smooth drug development.
See More
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- Study Progress: MediciNova's SEANOBI study has enrolled 50% of its target 200 participants, indicating significant clinical research advancement in ALS, which may provide new treatment options for patients.
- Funding Support: The study is backed by a $22 million NIH grant aimed at accelerating access to therapies for ALS patients, reflecting government commitment to this research area and confidence in MediciNova.
- Clinical Trials: The ongoing COMBAT ALS trial for MN-166 has enrolled 234 patients, with top-line results expected by the end of 2026, which will provide critical efficacy data that could influence future market performance.
- Drug Development: In addition to ALS, MN-166 is being developed for glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy, and substance use disorder, showcasing its broad potential indications that could diversify the company's revenue streams.
See More
MediciNova Activates SEANOBI Study with 100 Patient Enrollments
- Patient Enrollment Progress: As of the end of January 2026, MediciNova has successfully enrolled 100 ALS patients across 12 sites in the U.S., achieving 50% of the planned 200 enrollments, marking significant progress in the clinical development of MN-166 and potentially accelerating the drug approval process.
- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
See More
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Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
See More
MediciNova Completes Enrollment of 100 Patients for OXTOX Study on Chemotherapy-Induced Neuropathy
- Clinical Trial Progress: MediciNova has successfully enrolled 100 patients across 11 clinical sites in Australia for the OXTOX study, which evaluates MN-166's efficacy in preventing chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients, highlighting the company's ongoing commitment to neurodegenerative disease research.
- Study Design: This randomized, placebo-controlled Phase 2 trial allows participants to continue chemotherapy while receiving either MN-166 or a placebo, with the study expected to conclude six months post-chemotherapy, providing critical efficacy data for future development.
- Future Data Expectations: While the exact completion date is not yet determined, top-line data is anticipated to be available later in 2026, which will provide essential insights for MN-166's further development and could significantly impact its market prospects.
- Drug Background: MN-166 is a small molecule compound with multiple mechanisms of action, currently in late-stage clinical development for various neurodegenerative diseases, and has received Orphan Drug Designation and Fast Track Status from the FDA, indicating its potential in the market.
See More
MediciNova Completes Enrollment of 100 Patients in Phase 2 OXTOX Study for Chemotherapy-Induced Neuropathy
- Clinical Trial Progress: MediciNova has successfully completed patient enrollment of 100 individuals across 11 clinical sites in Australia for the OXTOX study, marking a significant advancement in research targeting chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients.
- Study Design: This randomized, placebo-controlled Phase 2 clinical trial aims to evaluate the efficacy of MN-166 (ibudilast) in chemotherapy patients, which is expected to provide critical data for future treatment options.
- Data Expectations: While the exact completion date of the study is not yet determined, top-line data is anticipated to be available in 2026, which will support further development and market potential for MN-166.
- Drug Background: MN-166, a small molecule compound with multiple mechanisms of action, has demonstrated a strong safety profile in clinical development for various neurodegenerative diseases, indicating its broad application prospects in the treatment landscape.
See More
MediciNova Reports Patient Data from 234 in ALS Clinical Trial
- Clinical Trial Progress: MediciNova has completed randomization of 234 participants in the COMBAT-ALS study, overcoming recruitment challenges during the COVID-19 pandemic, with top-line data expected by the end of 2026, potentially representing a significant therapeutic advance for ALS patients.
- Patient Demographics: Among participants, 36.8% were female and 63.2% male, with a mean age of 60.6 years and a racial distribution of 90.2% Caucasian, aligning with other ALS trials and enhancing the generalizability of the study findings.
- Drug Development Support: MediciNova is actively supporting patients wishing to continue MN-166 treatment through the FDA’s Individual Patient Expanded Access Program, demonstrating the company's commitment to ALS patients, with MN-166 receiving Orphan Drug and Fast Track Designation.
- Future Development Plans: The company is closely collaborating with experienced regulatory experts to prepare for the next steps in advancing MN-166, aiming to address uncertainties and risks in clinical trials to ensure smooth drug development.
See More
