Immunic Inc. (NASDAQ: IMUX) announced that enrollment in its two Phase 3 ENSURE‑1 and ENSURE‑2 studies of vidofludimus calcium has been completed. 1,121 patients were enrolled in ENSURE‑1 and 1,100 in ENSURE‑2, for a total of 2,221 participants across 15 countries. The oral therapy targets relapsing multiple sclerosis (RMS) and the company expects synchronized top‑line results by the end of 2026.
The enrollment milestone is a critical step toward regulatory submission. Vidofludimus calcium has shown neuro‑protective, anti‑inflammatory and anti‑viral activity in earlier Phase 2 trials (CALLIPER and EMPhASIS), and the large, geographically diverse Phase 3 population will provide a robust data set to assess efficacy and safety in a real‑world setting. If approved, the drug could become a competitive oral option in a market dominated by injectable and infusion therapies such as Roche’s Ocrevus.
Immunic remains a clinical‑stage company with no product revenue. The company’s cash burn has been supported by a $70.1 million capital raise in 2025, but recent trading below $1.00 triggered a transfer of its listing from the Nasdaq Global Select Market to the Nasdaq Capital Market on January 7, 2026. The company has a 180‑day grace period, ending June 22, 2026, to regain compliance with the minimum bid‑price requirement, underscoring the financial headwinds that accompany its clinical progress.
CEO Daniel Vitt said, “We now eagerly anticipate the synchronized top‑line data readout by the end of 2026. The scale, quality, and geographic breadth of the ENSURE trials give us exceptional confidence that the results will provide a clear and comprehensive picture of vidofludimus calcium’s potential to reshape the RMS treatment paradigm.” The statement highlights management’s optimism while acknowledging the importance of the upcoming data.
Analysts have maintained “Buy” ratings for Immunic, citing the pipeline’s upside potential. However, the Nasdaq compliance issue and the company’s lack of revenue remain significant risks. The market’s focus on the clinical milestone is tempered by concerns over cash runway and the need to achieve regulatory approval before the company can generate product sales.
The enrollment completion positions Immunic to move forward with regulatory filings and to deliver top‑line data that could validate its clinical strategy. At the same time, the company’s financial fragility and Nasdaq listing status mean that the upcoming data will be closely scrutinized for indications of commercial viability and the ability to sustain operations until a product launch.
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