Immunic reports Q2 EPS (20c), consensus (16c)

“During the second quarter and more recently, we have made substantial clinical progress in advancing our potentially transformative lead asset, vidofludimus calcium, an orally available nuclear receptor-related 1 (Nurr1) activator,” stated Daniel Vitt, Chief Executive Officer of Immunic (IMUX). “Most notable was the on-time completion of enrollment of our twin phase 3 ENSURE trials, bringing us one step closer to delivering a novel treatment option for people living with relapsing multiple sclerosis (RMS). The unique neuroprotective effects observed to date also support the phase 3 ENSURE trials, where confirmed disability worsening will be analyzed. Top-line data from both trials, expected by the end of 2026, will allow for a synchronized readout and a pooled analysis of this clinical endpoint. The growing body of evidence we have amassed continues to strengthen our confidence that, if approved, vidofludimus calcium, with a distinct combination of neuroprotective, anti-inflammatory and anti-viral properties observed, as well as a well-established safety and tolerability profile, has the potential to emerge as a differentiated oral therapy that addresses the complex pathophysiology of multiple sclerosis.”