Immunic Completes Enrollment for Phase 3 Trials of Vidofludimus Calcium in MS, Top-Line Data Expected by End of 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
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Should l Buy IMUX?
Source: Newsfilter
- 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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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: 0.589
Low
3.00
Averages
4.25
High
8.00
Current: 0.589
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.
Vidofludimus Calcium Shows Significant Efficacy in Multiple Sclerosis
- Clinical Trial Results: Immunic presented new data from its Phase 2 CALLIPER trial at the ACTRIMS Forum, demonstrating that Vidofludimus calcium significantly improves MRI markers of acute and chronic inflammation in patients with progressive multiple sclerosis (PMS), highlighting its potential in neuroprotection and antiviral effects.
- MRI Marker Improvement: In patients treated with Vidofludimus calcium, the proportion of Gd+ lesions decreased from 16.4% at baseline to 7.0% at week 72 and 0% at week 120, while the placebo group remained at 11.7% and 2.9%, indicating the drug's effectiveness in reducing acute inflammation.
- Antiviral Effects: Among 87 participants, the Vidofludimus calcium group showed a significant decline in EBV-specific T-cell receptor sequences (p=0.0004), suggesting that the drug may lower EBV reactivation rates, potentially impacting the progression of multiple sclerosis and reinforcing its hypothesized broad-spectrum antiviral effects.
- Future Research Directions: These findings support further investigation into the relationship between Vidofludimus calcium and clinical outcomes, particularly its influence on EBV T-cell responses, which may provide new insights for treating multiple sclerosis.
See More
Vidofludimus Calcium Shows Significant Efficacy in Multiple Sclerosis
- Clinical Trial Results: Immunic presented new data from the CALLIPER trial at the ACTRIMS Forum, showing that in PMS patients, the proportion of Gd+ lesions decreased from 16.4% at baseline to 7.0% at week 72, indicating the drug's potential in alleviating acute and chronic inflammation.
- MRI Marker Improvement: In the CALLIPER trial, the new and enlarging T2 lesion rate in the vidofludimus calcium group was 18.5%, significantly lower than the 30.0% in the placebo group, demonstrating the drug's effectiveness in controlling disease progression.
- Antiviral Effects: Among 87 participants, the EBV-specific T-cell receptor sequences in the vidofludimus calcium group showed a progressive decline, suggesting the drug may lower EBV reactivation rates, positively impacting MS disease progression.
- Future Research Directions: Immunic plans to further investigate the correlation between the anti-EBV T-cell response and clinical outcomes of vidofludimus calcium, aiming to provide new insights for MS treatment.
See More
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.
See More
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.
See More
Immunic to Participate in the 8th Annual Evercore ISI Healthcare Conference in December
Immunic's Conference Participation: Immunic, Inc. will have its CEO, Daniel Vitt, participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 4, 2025, and will also hold one-on-one investor meetings during the event.
Lead Development Program: The company's lead program, vidofludimus calcium (IMU-838), is in phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026, following promising phase 2 results.
Additional Drug Development: Immunic is also developing IMU-856, aimed at gastrointestinal diseases, and IMU-381, a next-generation molecule currently in preclinical testing, targeting specific gastrointestinal needs.
Forward-Looking Statements Caution: The press release includes cautionary statements regarding forward-looking statements, highlighting risks and uncertainties that could affect the company's future operations and clinical trial outcomes.
See More
HC Wainwright & Co. Upholds Buy Rating for Immunic (IMUX)
Analyst Recommendation: HC Wainwright & Co. has maintained a Buy recommendation for Immunic (NasdaqGS:IMUX), with a projected one-year price target of $6.41/share, indicating a potential upside of 718.72% from its current price of $0.78/share.
Fund Sentiment: There has been a 15.79% increase in the number of funds reporting positions in Immunic, with total shares owned by institutions rising by 7.50% to 52,173K shares.
Shareholder Activity: Notable shareholders include Standard Life Aberdeen and Bvf, with no changes in their holdings, while Tekla Life Sciences Investors significantly increased their stake by 76.60%.
Market Outlook: The put/call ratio for IMUX is 0.03, suggesting a bullish sentiment among investors regarding the stock's future performance.
See More
Vidofludimus Calcium Shows Significant Efficacy in Multiple Sclerosis
- Clinical Trial Results: Immunic presented new data from its Phase 2 CALLIPER trial at the ACTRIMS Forum, demonstrating that Vidofludimus calcium significantly improves MRI markers of acute and chronic inflammation in patients with progressive multiple sclerosis (PMS), highlighting its potential in neuroprotection and antiviral effects.
- MRI Marker Improvement: In patients treated with Vidofludimus calcium, the proportion of Gd+ lesions decreased from 16.4% at baseline to 7.0% at week 72 and 0% at week 120, while the placebo group remained at 11.7% and 2.9%, indicating the drug's effectiveness in reducing acute inflammation.
- Antiviral Effects: Among 87 participants, the Vidofludimus calcium group showed a significant decline in EBV-specific T-cell receptor sequences (p=0.0004), suggesting that the drug may lower EBV reactivation rates, potentially impacting the progression of multiple sclerosis and reinforcing its hypothesized broad-spectrum antiviral effects.
- Future Research Directions: These findings support further investigation into the relationship between Vidofludimus calcium and clinical outcomes, particularly its influence on EBV T-cell responses, which may provide new insights for treating multiple sclerosis.
See More
Vidofludimus Calcium Shows Significant Efficacy in Multiple Sclerosis
- Clinical Trial Results: Immunic presented new data from the CALLIPER trial at the ACTRIMS Forum, showing that in PMS patients, the proportion of Gd+ lesions decreased from 16.4% at baseline to 7.0% at week 72, indicating the drug's potential in alleviating acute and chronic inflammation.
- MRI Marker Improvement: In the CALLIPER trial, the new and enlarging T2 lesion rate in the vidofludimus calcium group was 18.5%, significantly lower than the 30.0% in the placebo group, demonstrating the drug's effectiveness in controlling disease progression.
- Antiviral Effects: Among 87 participants, the EBV-specific T-cell receptor sequences in the vidofludimus calcium group showed a progressive decline, suggesting the drug may lower EBV reactivation rates, positively impacting MS disease progression.
- Future Research Directions: Immunic plans to further investigate the correlation between the anti-EBV T-cell response and clinical outcomes of vidofludimus calcium, aiming to provide new insights for MS treatment.
See More
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.
See More
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.
See More
Immunic to Participate in the 8th Annual Evercore ISI Healthcare Conference in December
Immunic's Conference Participation: Immunic, Inc. will have its CEO, Daniel Vitt, participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 4, 2025, and will also hold one-on-one investor meetings during the event.
Lead Development Program: The company's lead program, vidofludimus calcium (IMU-838), is in phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026, following promising phase 2 results.
Additional Drug Development: Immunic is also developing IMU-856, aimed at gastrointestinal diseases, and IMU-381, a next-generation molecule currently in preclinical testing, targeting specific gastrointestinal needs.
Forward-Looking Statements Caution: The press release includes cautionary statements regarding forward-looking statements, highlighting risks and uncertainties that could affect the company's future operations and clinical trial outcomes.
See More
HC Wainwright & Co. Upholds Buy Rating for Immunic (IMUX)
Analyst Recommendation: HC Wainwright & Co. has maintained a Buy recommendation for Immunic (NasdaqGS:IMUX), with a projected one-year price target of $6.41/share, indicating a potential upside of 718.72% from its current price of $0.78/share.
Fund Sentiment: There has been a 15.79% increase in the number of funds reporting positions in Immunic, with total shares owned by institutions rising by 7.50% to 52,173K shares.
Shareholder Activity: Notable shareholders include Standard Life Aberdeen and Bvf, with no changes in their holdings, while Tekla Life Sciences Investors significantly increased their stake by 76.60%.
Market Outlook: The put/call ratio for IMUX is 0.03, suggesting a bullish sentiment among investors regarding the stock's future performance.
See More
