Immunic Inc

Immunic, Inc. is a biotechnology company that develops a pipeline of selective oral immunology therapies for chronic inflammatory and autoimmune diseases. Its lead program, IMU-838, is in Phase 3 and Phase 2 clinical development for relapsing and progressive multiple sclerosis and moderate-to-severe ulcerative colitis. The company is also developing IMU-856, entering Phase 2 for restoration of intestinal barrier function in gastrointestinal diseases such as celiac disease, inflammatory bowel disease, short bowel syndrome, and irritable bowel syndrome with diarrhea, and IMU-381, in preclinical development for gastrointestinal diseases. Immunic was founded in 2016 and is headquartered in New York, New York.

Biotech & Genomic Medicine▲

Immunic expects Phase 3 MS drug data by year-end, targets 2027 filing

Immunic Inc expects top-line data from its Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis by the end of 2026. If positive, the company plans to submit a New Drug Application in the US in mid-2027, with a potential regulatory decision in 2028. Immunic also intends to begin a Phase 3 program in progressive multiple sclerosis later this year, supported by Phase 2 CALLIPER data. The company reported second-quarter operating expenses of $35.3 million and a net loss of $34.1 million, or $0.80 per share, while ending the quarter with $155.1 million in cash expected to fund operations into late 2027.

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Biotech & Genomic Medicine

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