Immunic Inc (NASDAQ:IMUX, FRA:10VA) is preparing for a series of clinical and corporate milestones as it advances its lead drug candidate vidofludimus calcium through late-stage development in multiple sclerosis, while expanding its leadership team ahead of potential regulatory…
lings and commercialization. The biotechnology company reported second-quarter results on Tuesday and said its Phase 3 ENSURE-1 and ENSURE-2 trials evaluating vidofludimus calcium in relapsing multiple sclerosis remain on track to deliver top-line data by the end of 2026
If the results are positive, Immunic plans to submit a New Drug Application in the US in mid-2027, with a potential regulatory decision targeted for 2028. The company is also preparing to begin a Phase 3 program evaluating vidofludimus calcium in progressive multiple sclerosis later this year. The planned study follows data from the Phase 2 CALLIPER trial, including analyses presented at the 2026 Consortium of Multiple Sclerosis Centers annual meeting that covered disability progression, patient-reported outcomes, safety and tolerability.
Immunic has also made several changes to its management and board as it moves toward potential commercialization. Erik Lundgren was appointed chief executive officer in May and joined the board in July, while Michael A. Panzara became chief medical officer in April.