Immunic, Inc.

Immunic, Inc. is a late-stage biotechnology company dedicated to pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's mission is to create high-quality, orally administered treatment options that offer comprehensive therapeutic efficacy, outstanding safety, and tolerability for patients suffering from multiple sclerosis and other chronic inflammatory and autoimmune conditions. Immunic, Inc. is headquartered in New York City, while its operating subsidiary, Immunic AG, is based in Gräfelfing near Munich, Germany, where the company's research and development activities are primarily conducted.

The company's clinical pipeline features several orally administered small molecule therapies. Its lead development program, vidofludimus calcium (IMU-838), is currently in Phase 3 clinical trials for relapsing multiple sclerosis, having previously demonstrated therapeutic activity in Phase 2 trials for relapsing-remitting multiple sclerosis and progressive multiple sclerosis. IMU-838 functions as a first-in-class nuclear receptor-related 1 (Nurr1) activator, providing neuroprotective effects, and also exhibits anti-inflammatory and anti-viral properties by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). Another significant program, IMU-856, is designed to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in gastrointestinal diseases such as celiac disease and inflammatory bowel disease. Additionally, Immunic is advancing IMU-381, a program in preclinical testing, leveraging its Nurr1 platform for various neurologic, gastrointestinal, and other autoimmune diseases.

In February 2026, Immunic successfully closed an oversubscribed private placement, securing up to $400 million in funding. This capital is intended to support the completion of its Phase 3 ENSURE trials for relapsing multiple sclerosis, initiate a new Phase 3 trial for primary progressive multiple sclerosis, and facilitate the company's strategic transition into a commercial-stage entity. Top-line data from the ENSURE trials is anticipated by the end of 2026, with a New Drug Application (NDA) submission to the FDA projected for mid-2027. Recent corporate developments include a 1-for-10 reverse stock split in April 2026, the appointment of Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer in April 2026, and the strengthening of its Board of Directors with the addition of Jon Congleton in March 2026. The company is actively preparing for the potential commercialization of its lead therapeutic candidate.