Core Insights - Immunic Inc presented new data from the CALIPER Phase 2 trial at the ACTRIMS Forum, focusing on progressive multiple sclerosis (MS) and highlighting the efficacy of Vidofludimus calcium in reducing both acute and chronic inflammation [1][2][3] Group 1: CALIPER Trial Findings - The CALIPER trial showed a statistically significant reduction in slowly expanding lesions (SELs) for the 45mg dose of Vidofludimus calcium compared to placebo, indicating potential efficacy on chronic inflammation [7] - Vidofludimus calcium demonstrated a reducing effect on gadolinium-enhancing and T2 lesions, suggesting its impact on acute inflammation in MS [5] Group 2: EBV Reactivation Study - The trial provided clinical evidence of reduced Epstein-Barr virus (EBV) reactivation compared to placebo, which is significant given the role of EBV in MS progression [9] - T-cell receptor repertoire analysis indicated that under treatment with Vidofludimus calcium, EBV antigens dropped in ranking, suggesting fewer reactivations [10] Group 3: Future Outlook - Immunic is preparing for the readout of Phase 3 trials in relapsing MS, with results expected at the end of 2026 from two identical trials enrolling over 1,100 patients each, totaling more than 3,000 individuals [12]

Immunic Inc (NASDAQ:IMUX) is surging Friday after the late‑stage biotech announced a private placement of up to $400 million.Immunic stock is gaining positive traction. Why are IMUX shares climbing?A Look At The DealThe financing was led by existing investor BVF Partners and included a strong lineup of institutional backers such as OrbiMed, RA Capital, Janus Henderson, Avidity Partners and EcoR1 Capital.The structure provides $200 million upfront through pre‑funded warrants priced at 87 cents each, with the ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Core Viewpoint - Immunic, Inc. has announced an oversubscribed private placement of up to USD 400 million to facilitate its transition into a commercial-stage company, focusing on the development of novel oral therapies for neurologic diseases, particularly multiple sclerosis [1][2]. Financing Details - The private placement will provide upfront proceeds of USD 200 million, with the potential for an additional USD 200 million through warrants [1][2]. - The financing was led by existing investor BVF Partners L.P. and included participation from various institutional investors [1][2]. - The company plans to use the net proceeds to fund clinical trials, operations, and general corporate purposes, with expectations to support activities through late 2027 [2]. Clinical Development Plans - Immunic aims to initiate a Phase 3 clinical program for primary progressive multiple sclerosis (PPMS) later this year, which is expected to take approximately 3.5 to 4 years to complete [1]. - The ongoing Phase 3 ENSURE trials for vidofludimus calcium in relapsing multiple sclerosis (RMS) are expected to yield top-line data by the end of 2026, with a New Drug Application (NDA) submission planned for mid-2027 [1][2]. Product Mechanism and Potential - Vidofludimus calcium is designed to provide neuroprotective effects and reduce inflammatory damage, addressing key biological drivers of disability progression in multiple sclerosis [1]. - The drug's mechanism involves enhancing neuronal survival through nuclear receptor-related 1 (Nurr1) activation and selective inhibition of dihydroorotate dehydrogenase (DHODH) [1]. Leadership Changes - Dr. Daniel Vitt, the co-founder and CEO, will transition to a new role focused on scientific strategy, while the search for a new CEO with commercial expertise in the MS space is underway [1][2]. - Simona Skerjanec has been appointed as the interim Chairperson of the Board of Directors, bringing significant experience from her previous role at Roche [1][2].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the team includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain best practices in content production and search engine optimization [5]

Core Insights - Immunic, Inc. is presenting additional data from its phase 2 CALLIPER trial for vidofludimus calcium at the ACTRIMS Forum 2026, highlighting its potential in treating progressive multiple sclerosis (PMS) [1][2] Group 1: Trial Data and Findings - The CALLIPER trial data indicates that treatment with vidofludimus calcium resulted in a significant reduction in gadolinium-enhancing lesions from 16.4% at baseline to 7.0% at week 72 and 0% at week 120, compared to placebo [1] - The proportion of patients with new and/or enlarging T2 lesions was 18.5% in the vidofludimus calcium group versus 30.0% in the placebo group at week 72, with statistically significant differences in mean change of T2 lesion volume at weeks 48, 72, and 96 [1] - Statistically significant reductions in slowly expanding lesions (SEL) were observed at week 96, with least squares means of 2.935 for vidofludimus calcium and 3.840 for placebo (p<0.05) [1] Group 2: Antiviral Effects - Data from a subset of 87 participants showed that patients treated with vidofludimus calcium experienced a progressive decline in EBV-specific T-cell receptor matches over time, indicating reduced EBV reactivations during treatment, with a statistically significant difference (p=0.0004) compared to placebo [2] - The findings support the hypothesis that vidofludimus calcium's broad-spectrum antiviral effects may lower EBV reactivations, potentially addressing MS disease progression related to ongoing EBV reactivations [2] Group 3: Drug Profile and Company Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [2] - The drug combines neuroprotective, anti-inflammatory, and antiviral effects by activating the Nurr1 transcription factor and selectively inhibiting dihydroorotate dehydrogenase (DHODH) [2] - Immunic, Inc. is a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases, with its lead program in phase 3 trials for relapsing multiple sclerosis [2]

Core Insights - Immunic, Inc. (NASDAQ:IMUX) has experienced a significant share price increase of 24.10% over the past five days as of January 9, 2026, following a review of its 2025 performance and upcoming milestones [2] Group 1: Company Performance and Milestones - The company has completed enrollment in the Phase 3 ENSURE-1 and ENSURE-2 trials for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS), with 1,121 and 1,100 patients enrolled across over 100 sites in 15 countries [3] - A synchronized top-line readout is anticipated by the end of 2026 to evaluate the therapy's potential in modifying disease progression [3] - Long-term Phase 2 EMPhASIS data confirmed that over 92% of patients remained free of 24-week confirmed disability worsening after up to 5.5 years, indicating durable disability protection [4] Group 2: Clinical Data and Research - Data from the Phase 2 CALLIPER trial in progressive MS showed statistically significant reductions in 24-week confirmed disability worsening, supporting neuroprotective effects independent of inflammation [5] - The company is also advancing IMU-856, a small molecule modulator targeting Sirtuin 6 (SIRT6), which has shown promising early clinical and preclinical signals for gastrointestinal barrier restoration and weight management [6] Group 3: Financial Position and Strategy - Immunic plans to expand its oral immunology portfolio, supported by strong financing in 2025, including a $65 million public offering to advance its programs [6] - The company focuses on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases, including multiple sclerosis, ulcerative colitis, and Crohn's disease [7]

Core Insights - Immunic, Inc. (NASDAQ:IMUX) has experienced a significant share price increase of 24.10% over the past five days as of January 9, 2026, following a review of its 2025 performance and upcoming milestones [2] Group 1: Company Performance and Milestones - The company has completed enrollment in the Phase 3 ENSURE-1 and ENSURE-2 trials for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS), with 1,121 and 1,100 patients enrolled across over 100 sites in 15 countries [3] - A synchronized top-line readout is anticipated by the end of 2026 to evaluate the therapy's potential in modifying disease progression [3] - Long-term Phase 2 EMPhASIS data confirmed durable disability protection in relapsing-remitting MS (RRMS), with over 92% of patients remaining free of 24-week confirmed disability worsening after up to 5.5 years [4] Group 2: Clinical Trial Results - The Phase 2 CALLIPER trial in progressive MS demonstrated statistically significant reductions in 24-week confirmed disability worsening (24wCDW), indicating neuroprotective effects independent of inflammation [5] Group 3: Product Development and Financing - Management discussed IMU-856, a small molecule modulator targeting Sirtuin 6 (SIRT6), which has shown promising early clinical and preclinical signals for gastrointestinal barrier restoration and weight management [6] - The company plans to expand its oral immunology portfolio, supported by strong financing in 2025, including a $65 million public offering to advance its programs [6] Group 4: Company Focus - Immunic, Inc. is dedicated to developing selective oral immunology therapies aimed at chronic inflammatory and autoimmune diseases, including multiple sclerosis, ulcerative colitis, and Crohn's disease [7]

Core Insights - Immunic Inc's CEO highlighted significant milestones in 2025, particularly the phase 2 CALLIPER study, which showed a 31% reduction in confirmed disability worsening in progressive multiple sclerosis (MS) patients and a 34% reduction in those without baseline gadolinium lesions, indicating a potential neuroprotective effect of vidofludimus calcium [1][5] Clinical Developments - The CALLIPER study results suggest that vidofludimus calcium can address both inflammatory and non-inflammatory processes driving disability progression in MS, benefiting patients with relapsing forms of the disease [6] - Long-term data from the EMPhASIS study indicated that 92.3% of relapsing-remitting MS patients remained free of 12-week confirmed disability worsening after 144 weeks, with only 13.8% of events being independent of relapses, supporting the drug's efficacy [2][7] Patent and Strategic Positioning - Immunic has strengthened its patent position for vidofludimus calcium, potentially securing exclusivity until 2041 in key markets, which provides a significant competitive advantage [3][8] - Early findings on IMU-856 in celiac disease showed increases in natural GLP-1 levels, suggesting potential applications in gut health and weight management [3][8] Future Outlook - Enrollment in the phase 3 ENSURE trials is complete, with top-line data expected by the end of 2026, which is crucial for FDA submission and potential market launch [9][10] - The company is preparing for a New Drug Application (NDA) submission and aims for a commercial launch in 2028, contingent on FDA approval [11]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for being a forward-looking technology adopter, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]