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BARCELONA - Immunic, Inc. (NASDAQ:IMUX), a clinical-stage biopharmaceutical company with a current market capitalization of $87 million, announced that its experimental multiple sclerosis drug vidofludimus calcium demonstrated statistically significant 24-week confirmed disability improvement in a Phase 2 trial for progressive multiple sclerosis, according to data presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
The CALLIPER trial showed patients receiving vidofludimus calcium had over two-fold probability of disability improvement compared to placebo in the overall study population, with consistent effects across disease subtypes. The drug also demonstrated positive signals for slowing disability progression across various endpoints and patient subgroups, including those without evidence of focal inflammation. According to InvestingPro data, while the company maintains a strong liquidity position with more cash than debt, it faces significant financial challenges with rapid cash burn rates typical of clinical-stage biotech companies.
Dr. Robert J. Fox, coordinating investigator of the CALLIPER trial, noted that the data "support the hypothesis that Nurr1 activation may represent a novel mechanism to prevent neurodegeneration in MS." The drug’s safety profile was described as favorable, with adverse event rates similar to placebo.
Additionally, long-term data from the Phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis showed high rates of patients remaining free of disability worsening, with 92.3% of patients free of 12-week confirmed disability worsening at week 144. With analyst price targets ranging from $4 to $10 per share, investors can access detailed valuation analysis and 8 additional key insights through InvestingPro’s comprehensive research reports.
Vidofludimus calcium is currently in Phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. The company describes the drug as having a dual mode of action that combines neuroprotective effects through Nurr1 activation with anti-inflammatory and anti-viral effects through inhibition of the enzyme dihydroorotate dehydrogenase. Investors should note that the company’s next earnings report is scheduled for November 6, 2025, which could provide crucial updates on the trial’s progress and financial outlook.
The information in this article is based on a company press release statement.
In other recent news, Immunic, Inc. has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering dose strengths of its lead asset, vidofludimus calcium, for treating progressive multiple sclerosis. The patent includes daily doses ranging from 10 mg to 45 mg, marking the fifth U.S. patent for this treatment. Additionally, B.Riley has adjusted its price target for Immunic to $4.00 from $5.00, maintaining a Buy rating as the company approaches a "catalyst-rich period" with significant developments expected. H.C. Wainwright reiterated its Buy rating with a $10.00 price target, citing positive long-term data from the Phase 2 EMPhASIS trial for relapsing-remitting multiple sclerosis. The trial showed promising results, with over 92% of patients remaining free of confirmed disability worsening. In corporate developments, Immunic’s board authorized up to 35 million stock appreciation rights for employees and executive officers, pending final approval and shareholder consent. These rights may be settled in shares of common stock if the company’s 2019 Omnibus Equity Incentive Plan is amended. Until then, the rights could be settled in cash.
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