Roth Capital Partners analyst Boobalan Pachaiyappan says MediciNova (MediciNova Stock Quote, Chart, News, Analysts, Financials NASDAQ:MNOV) lead ALS drug could offer a differentiated approach to a disease with limited treatment options.
In a Sept. 17 initiation report, Pachaiyappan launched coverage of MediciNova with a “Buy” rating and US$6.00 target.
His thesis is based on unmet need in amyotrophic lateral sclerosis, early clinical evidence for Ibudilast, also known as MN-166, and an ongoing Phase 2b/3 study expected to report data in Q4 2026.
“Assuming positive results, MNOV could seek FDA approval in 2H27 and potentially launch the drug in 2H28,” Pachaiyappan said.
MediciNova is developing oral small-molecule therapies, with MN-166 as its lead asset. The drug is licensed from Kyorin Pharma and is already approved in Japan and South Korea for asthma and post-stroke dizziness.
“MediciNova believes MN-166’s multimodal mechanism could be repurposed to target neuroinflammation and aid the repair and survival of nerve cells in ALS patients,” Pachaiyappan said.
In a Phase 1b/2a study of 51 patients, MN-166 showed disease stabilization in 21.2% of patients versus 12.5% for placebo after six months of therapy. The study also showed a survival benefit over 36 months, with no safety signals.
The confirmatory Phase 2b/3 study is fully enrolled with 234 patients and will evaluate treatment over 12 months.
Pachaiyappan said ALS severity and limited treatment options could support regulatory flexibility if MN-166 shows benefits in motor function and survival.
The analyst estimates MN-166 could enter the U.S. market in the second half of 2028 and Europe in 2030. His model assumes peak risk-unadjusted U.S. and EU5 revenue of about US$1.7-billion in 2035, with MediciNova’s share at US$496-million.
Key catalysts include MN-001 Phase 2 data, MN-166 Phase 2b/3 ALS data in late 2026 or early 2027, a potential NDA filing in the second half of 2027 and possible FDA approval and U.S. launch in 2028.
MediciNova ended Q2 2026 with about US$25-million of cash, which management expects to fund operations into the second half of 2027.
Pachaiyappan’s US$6 target is based on a discounted cash flow analysis using a 12% discount rate.
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