Immunic Completes Enrollment for Phase 3 Trials of Vidofludimus Calcium, Top-Line Data Expected by End of 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
0mins
Source: PRnewswire
- Trial Enrollment Completed: Immunic has completed enrollment for its twin Phase 3 ENSURE trials of Vidofludimus Calcium in relapsing multiple sclerosis, with top-line data expected by the end of 2026, which will significantly bolster the company's leadership position in the neurology sector.
- Efficacy Data Significant: Phase 2 CALLIPER trial results demonstrated that Vidofludimus Calcium significantly reduced confirmed disability worsening events over 24 weeks and increased disability improvement rates, indicating the drug's potential to reshape treatment paradigms in multiple sclerosis.
- Long-Term Safety Profile: Long-term open-label data from the Phase 2 EMPhASIS trial showed that a substantial majority of patients remained free from confirmed disability worsening events during follow-up, highlighting Vidofludimus Calcium's safety and tolerability in long-term management, thereby enhancing patient quality of life.
- Strengthened Intellectual Property: The U.S. has granted a patent for dose strengths of Vidofludimus Calcium in progressive multiple sclerosis, extending intellectual property protection until 2041, which will provide Immunic with a stronger competitive edge and commercialization potential.
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Analyst Views on IMUX
Wall Street analysts forecast IMUX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IMUX is 4.25 USD with a low forecast of 3.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.610
Low
3.00
Averages
4.25
High
8.00
Current: 0.610
Low
3.00
Averages
4.25
High
8.00
About IMUX
Immunic, Inc. is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The Company is engaged in pursuing clinical development of programs, which include the vidofludimus calcium (IMU-838) program, which is in Phase III clinical development for patients with relapsing multiple sclerosis (RMS), and which has shown therapeutic activity in Phase II clinical trials in patients suffering from relapsing-remitting MS, progressive MS and moderate-to-severe ulcerative colitis; the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease, Graft-versus-Host-Disease and weight management, and the IMU-381 program, which is a molecule being developed to specifically address the needs of gastrointestinal diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Immunic Completes Enrollment for Phase 3 Trials of Vidofludimus Calcium in MS, Top-Line Data Expected by End of 2026
- Trial Enrollment Completion: Immunic has completed enrollment of 2,221 patients across over 100 sites in 15 countries for its Phase 3 ENSURE-1 and ENSURE-2 trials, with top-line data expected by the end of 2026, which will provide critical clinical evidence for multiple sclerosis treatment.
- Positive Clinical Data: The Phase 2 CALLIPER trial demonstrated that Vidofludimus Calcium significantly reduced the 24-week confirmed disability worsening rate in progressive multiple sclerosis patients, achieving positive effects even in those without baseline inflammatory markers, reinforcing its neuroprotective mechanism potential.
- Long-Term Safety Data: In the Phase 2 EMPhASIS trial, 92.3% of patients remained free of confirmed disability worsening events at week 144, indicating good long-term safety and tolerability of Vidofludimus Calcium, potentially offering patients greater independence.
- Intellectual Property Protection: Immunic received a Notice of Allowance from the USPTO for dose strengths of Vidofludimus Calcium in progressive multiple sclerosis, with intellectual property protection extending to 2041, enhancing the company's competitive position in the market.
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Immunic Completes Enrollment for Phase 3 Trials of Vidofludimus Calcium, Top-Line Data Expected by End of 2026
- Trial Enrollment Completed: Immunic has completed enrollment for its twin Phase 3 ENSURE trials of Vidofludimus Calcium in relapsing multiple sclerosis, with top-line data expected by the end of 2026, which will significantly bolster the company's leadership position in the neurology sector.
- Efficacy Data Significant: Phase 2 CALLIPER trial results demonstrated that Vidofludimus Calcium significantly reduced confirmed disability worsening events over 24 weeks and increased disability improvement rates, indicating the drug's potential to reshape treatment paradigms in multiple sclerosis.
- Long-Term Safety Profile: Long-term open-label data from the Phase 2 EMPhASIS trial showed that a substantial majority of patients remained free from confirmed disability worsening events during follow-up, highlighting Vidofludimus Calcium's safety and tolerability in long-term management, thereby enhancing patient quality of life.
- Strengthened Intellectual Property: The U.S. has granted a patent for dose strengths of Vidofludimus Calcium in progressive multiple sclerosis, extending intellectual property protection until 2041, which will provide Immunic with a stronger competitive edge and commercialization potential.
Continue Reading