Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive Multiple Sclerosis
Rhea-AI Summary
Immunic (Nasdaq: IMUX) will present one late-breaking and two additional posters at the 2026 CMSC Annual Meeting, sharing new phase 2 CALLIPER data for vidofludimus calcium in progressive multiple sclerosis.
Highlights include a novel unified disability endpoint, stable mood-related PROs, and safety/tolerability largely comparable to placebo over 120 weeks.
AI-generated analysis. Not financial advice.
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Key Figures
Market Reality Check
Peers on Argus
IMUX gained 7.94% while peers showed mixed moves (e.g., ATRA +9.9%, IGMS -2.31%, CRVO -1.29%), pointing to stock-specific interest around the new CALLIPER data.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 04 | CALLIPER data update | Positive | -5.4% | ACTRIMS CALLIPER data with MRI and EBV-related benefits vs placebo. |
| Jun 24 | EMPhASIS OLE data | Positive | +0.0% | Long-term RRMS OLE data with high CDW-free rates and sustained safety. |
| Jun 05 | ENSURE enrollment, CALLIPER | Positive | -0.3% | ENSURE Phase 3 enrollment completion plus additional positive CALLIPER PMS data. |
| Apr 30 | CALLIPER topline results | Positive | -22.6% | CALLIPER showing reduced disability worsening risk and favorable safety profile. |
| Nov 13 | IMU-856 Phase 1/1b | Positive | +1.7% | Phase 1/1b IMU-856 data in celiac disease with positive gut endpoints. |
Clinical trial updates have often been followed by muted or negative one-day reactions despite generally positive data narratives, with only one of five prior tagged events showing a positive price alignment.
Over the past 18 months, Immunic has repeatedly reported positive clinical data across its MS programs and IMU-856, including CALLIPER and EMPhASIS updates and Phase 1/1b results in celiac disease. Yet, several prior CALLIPER readouts in 2025 and an ACTRIMS presentation in February 2026 coincided with flat or negative one-day moves. Today’s additional CALLIPER safety, disability and PRO analyses at CMSC extend this clinical narrative, reinforcing vidofludimus calcium’s profile within the existing progression-focused data set.
Historical Comparison
In the last five clinical-trial releases, IMUX averaged a -5.32% one-day move, often selling off on positive data. Today’s +7.94% gain on additional CALLIPER analyses stands out versus that pattern.
Clinical updates have tracked vidofludimus calcium from Phase 2 CALLIPER and EMPhASIS data toward Phase 3 ENSURE completion, while also expanding evidence of neuroprotection, disability outcomes and long-term safety across MS populations.
Regulatory & Risk Context
An effective S-3/A shelf dated 2026-04-30 registers up to 45,815,180 resale shares from pre-funded and common warrants. Immunic would not receive proceeds from resales but would receive cash if the warrants (aggregate exercise proceeds about $200.0M) are exercised.
Market Pulse Summary
This announcement expanded Phase 2 CALLIPER data, introducing a unified disability endpoint and detailed safety and patient-reported outcomes across up to 120 weeks in 467 patients with progressive multiple sclerosis. The results showed broadly comparable adverse event rates to placebo and no signal for worsened mood, while treatment satisfaction tended to favor vidofludimus calcium. Set against a history of mixed market reactions to clinical news, investors may watch future Phase 3 ENSURE readouts and any warrant-driven share resales under the S-3/A.
Key Terms
progressive multiple sclerosis medical
post-hoc analyses technical
patient-reported outcomes medical
treatment-emergent adverse events medical
AI-generated analysis. Not financial advice.
– Late-Breaking Poster Introduces New Unified Statistical Analyses for Assessing Confirmed Disability Changes for Trials in Progressive Multiple Sclerosis –
– Additional CALLIPER Data Further Highlight Vidofludimus Calcium's Favorable Safety and Tolerability Profile; Patient-Reported Outcomes Assessments Show No Negative Impact on Mood –
"We believe the new data presented in these three posters at the prestigious CMSC Annual Meeting continues to demonstrate a consistent and differentiated profile for vidofludimus calcium in multiple sclerosis (MS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The late-breaking analysis is particularly interesting, as it introduces a new and potentially more comprehensive way to measure overall disability change by capturing both slowing of progression and improvement of disease. Together with supportive safety, tolerability and patient-reported data, these findings further strengthen our confidence in the potential of vidofludimus calcium to address key drivers of MS disease progression."
"These post-hoc analyses from the phase 2 CALLIPER trial provide valuable insights as to the effects of vidofludimus calcium in patients with progressive MS," added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. "Whereas disability in MS is commonly measured by 3- or 6-months confirmed disability worsening, our late-breaking poster presents a novel approach capturing both worsening and improvement on treatment, allowing for a more comprehensive assessment of well-being. In applying these assessments, we observed favorable effects of vidofludimus calcium versus placebo. These data, combined with a safety and tolerability profile that appears favorable, supports the continued development of vidofludimus calcium for progressive MS."
Late-Breaking Poster Presentation Details:
- Poster Title: Novel Unified Statistical Analyses for Confirmed Disability Changes in Multiple Sclerosis for Capturing Possible Neuroprotective Effects
- Presenting Author: James Myles, Global Head of Biostatistics at Immunic
- Abstract ID: 11244
- Poster Board Label: LBA14
- Session Date: Thursday, May 28, 2026
- Session Time: 5:00-7:00 pm ET
- Location: Exhibit Hall
This late-breaking poster introduces a novel unified endpoint, Confirmed Disability Change (CDC), designed to capture both confirmed disability worsening (CDW) and confirmed disability improvement (CDI) within a single statistical framework. Three complementary statistical approaches, including ordinal categorical analysis, time-to-event modeling and Markov state change modeling, were applied post-hoc to data from the phase 2 CALLIPER trial in PMS. Across these models, results consistently favored vidofludimus calcium over placebo.
These findings suggest that the CDC approach may provide a more complete view of disability trajectories in PMS than conventional one-direction analyses, particularly for evaluating possible neuroprotective effects. Broader adoption of such an integrated endpoint may improve statistical power in future clinical trials and help better capture treatment benefits for patients with PMS.
Poster Presentation Details:
- Poster Title: Effect of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor, on Patient-Reported Outcomes (PRO) in Progressive MS: Data from Phase 2 CALLIPER Trial
- Presenting Author: Julie Korich, Ph.D., Senior Medical Director, Medical Affairs at Immunic
- Abstract ID: 10843
- Poster Board Label: DMT10
- Session Date: Thursday, May 28, 2026
- Session Time: 5:00-7:00 pm ET
- Location: Exhibit Hall B
This poster presents patient-reported outcomes from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, including measures of severity of depressive thoughts (Patient Health Questionnaire-9, PHQ-9) and overall treatment satisfaction (Treatment Satisfaction Questionnaire for Medication), collected over the treatment period of up to 120 weeks.
Analyses using a mixed model repeated measures (MMRM) approach showed that changes in PHQ-9 scores were similar between vidofludimus calcium and placebo across all assessed timepoints, including weeks 48, 72 and 120. At week 48, PHQ-9 scores numerically improved in both groups (vidofludimus calcium: -0.786 vs. placebo: -0.347), with a similar pattern observed at week 72 (vidofludimus calcium:
-0.568 vs. placebo: -0.609) and week 120 (vidofludimus calcium: -1.777 vs. placebo: -0.525). There was no indication of worsening depressive or suicidal thoughts with vidofludimus calcium (n=235) as compared to placebo (n=232) through 120 weeks.
Patient-reported treatment effectiveness numerically favored vidofludimus calcium over placebo, particularly in perceived effectiveness at both week 48 (77.51 vs. 72.88) and week 120 (84.69 vs. 79.20), while side effect burden remained comparable between the treatment groups at both timepoints (97.65 vs. 97.70 at week 48 and 99.44 vs. 99.36 at week 120). Although exploratory in nature, these findings support a favorable patient-reported profile for vidofludimus calcium over two years.
Presentation Details:
- Poster Title: Safety and Tolerability of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor: Data from Phase 2 CALLIPER Trial
- Presenting Author: Alex Lublin, Ph.D., Senior Medical Director, Medical Affairs at Immunic
- Abstract ID: 10995
- Poster Board Label: DMT11
- Session Date: Thursday, May 28, 2026
- Session Time: 5:00-7:00 pm ET
- Location: Exhibit Hall B
This poster provides an overview of safety and tolerability data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, based on 467 patients treated for up to 120 weeks.
The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between vidofludimus calcium (
The collective data set shows a similar overall adverse events profile between vidofludimus calcium and placebo. These results are consistent with previous clinical experience and support the favorable safety and tolerability profile of vidofludimus calcium in patients with PMS.
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an orally administered investigational small molecule drug, currently in late-stage clinical trials for multiple sclerosis (MS). Vidofludimus calcium has a unique mode of action designed to combine neuroprotective, anti-inflammatory and anti-viral effects to address key biological drivers of MS. As a selective immune modulator, it activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which has been associated with direct and indirect neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which has been associated with anti-inflammatory and anti-viral effects. Vidofludimus calcium is currently being evaluated in the phase 3 ENSURE trials for the treatment of relapsing MS. In the phase 2 EMPhASIS trial, it showed therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. In the phase 2 CALLIPER trial in progressive MS patients, vidofludimus calcium showed promising clinical signals, including reductions in confirmed disability progression and statistically significant confirmed disability improvement. To date, more than 3,400 individuals have been exposed to vidofludimus calcium and it has shown a favorable pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country and its efficacy, safety and tolerability are still being evaluated in ongoing clinical trials.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomic trends, impacts of the
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
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