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Immunic, Inc. (Nasdaq: IMUX) is a leading clinical-stage biopharmaceutical company focused on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases. With a dedicated pursuit of innovative solutions, Immunic is at the forefront of transforming therapeutic approaches for conditions such as relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis.
The company’s flagship product, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Currently in phase 2 and 3 clinical trials for various indications, IMU-838 has shown promising results in treating relapsing-remitting and progressive multiple sclerosis as well as moderate-to-severe ulcerative colitis. Additionally, IMU-838's mechanism as a nuclear receptor related 1 (Nurr1) activator underscores its potential neuroprotective effects.
Immunic is also advancing IMU-935, an inverse agonist of RORγt, and IMU-856, which aims to restore intestinal barrier function. IMU-856 is particularly notable for its innovative approach to gastrointestinal diseases, such as celiac disease and irritable bowel syndrome with diarrhea, by focusing on bowel architecture regeneration rather than immunomodulation.
Financially, Immunic has fortified its position with a significant private placement of up to $240 million, ensuring a strong cash runway through key clinical milestones. The company boasts robust partnerships with top-tier investors like BVF Partners and Janus Henderson Investors, reflecting strong market confidence in its clinical programs.
Highlighting its cutting-edge research, Immunic has presented pivotal data at prominent medical conferences, including the ACTRIMS Forum and has its results published in esteemed journals such as Neurology® Neuroimmunology & Neuroinflammation. These milestones not only solidify Immunic's scientific credibility but also mark significant progress in its clinical pipeline.
As of the latest updates, Immunic is gearing up for major clinical readouts, including the top-line data from the phase 2 CALLIPER trial expected in April 2025, and interim analyses from the phase 3 ENSURE trials anticipated in late 2024. The company’s achievements in these trials could potentially position vidofludimus calcium as a groundbreaking treatment option in the MS landscape.
Immunic continues to expand its patent portfolio, securing intellectual property rights that extend protection into the next two decades. This strategic move not only enhances its market exclusivity but also strengthens its competitive edge in the biotech industry.
Overall, Immunic, Inc. is poised for significant impact with its innovative oral therapies, backed by a strong financial foundation, strategic partnerships, and a commitment to addressing unmet medical needs in chronic inflammatory and autoimmune diseases.
Immunic (NASDAQ: IMUX) announced new data showing that IMU-856, their oral SIRT6 modulator, demonstrated promising results for potential weight management applications. A post hoc analysis of their phase 1b celiac disease trial revealed a dose-dependent increase in GLP-1 levels of up to 250% versus placebo, showing high statistical significance (p=0.014 for 80mg; p=0.003 for 160mg).
The clinical findings were supported by a 6-month preclinical study where IMU-856 reduced body weight gain and food consumption by up to 40% compared to the control group. The company suggests that SIRT6 modulation could potentially offer a broader activation of enteroendocrine hormones compared to current injectable treatments.
IMU-856 is now phase 2 ready and could target the obesity market, which is expected to reach over $170 billion globally by 2031. The drug's potential as an oral alternative to current injectable treatments could represent a significant market opportunity.
Immunic (Nasdaq: IMUX) has announced its participation in several key investor and scientific conferences throughout February 2025. The company will present at the BIO CEO & Investor Conference and Oppenheimer 35th Annual Healthcare Life Sciences Conference, where CEO Daniel Vitt will conduct meetings and participate in a fireside chat.
At the 19th Congress of ECCO, the company will present two digital oral presentations on IMU-856, their oral small molecule modulator targeting SIRT6. The presentations will focus on clinical and preclinical data regarding barrier regeneration effects.
Additionally, at the 7th Neuroimmunology Drug Development Summit, CSO Hella Kohlhof will present on vidofludimus calcium (IMU-838). The company will also participate in the ACTRIMS Forum 2025, presenting two posters on multiple sclerosis research, including baseline characteristics across major clinical trials and vidofludimus calcium's potential neuroprotective function.
Immunic (NASDAQ: IMUX) highlighted its 2024 achievements and upcoming milestones for its lead drug candidate vidofludimus calcium. The company expects top-line data from Phase 2 CALLIPER trial in progressive multiple sclerosis in April, while its twin Phase 3 ENSURE trials in relapsing multiple sclerosis are progressing as planned for completion in 2026.
The company secured a three-tranche private placement totaling up to $240 million, with an initial tranche of $80 million completed in January 2024, extending cash runway into Q3 2025. The Phase 3 ENSURE program received positive interim analysis results, with the Independent Data Monitoring Committee recommending continuation without changes.
Additionally, Immunic strengthened its management team with key appointments and published positive results from the Phase 1/1b trial of IMU-856 in The Lancet Gastroenterology & Hepatology, showing promising effects in celiac disease patients.
Immunic, Inc. (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. CEO Daniel Vitt will lead a fireside chat on December 5, 2024, at 11:30 am ET in New York.
The company's leadership team, including CFO Glenn Whaley and VP of Investor Relations Jessica Breu, will be available for one-on-one investor meetings during the conference, which runs from December 3-5, 2024. A webcast of the event will be accessible on Immunic's website with a 90-day replay availability.
Immunic (NASDAQ: IMUX) announced the publication of its phase 1/1b clinical trial data for IMU-856 in The Lancet Gastroenterology & Hepatology. The trial evaluated IMU-856, an oral SIRT6 modulator, in healthy subjects and celiac disease patients. The study included 71 healthy subjects in Parts A and B, and 43 celiac disease patients in Part C. The trial demonstrated positive effects in four key areas: gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement. Both 80mg and 160mg doses were found to be safe and well-tolerated, with no serious adverse events reported. The treatment shows promise as a potential first-in-class oral therapy for celiac disease, which currently affects 1.4% of the global population.
Immunic (NASDAQ: IMUX) reported Q3 2024 financial results and corporate updates. The company announced positive interim analysis of its Phase 3 ENSURE program for multiple sclerosis, with the Independent Data Monitoring Committee confirming trials should continue as planned. R&D expenses were $21.4M for Q3 2024, up from $19.8M in Q3 2023. Net loss was $24.4M ($0.24 per share) compared to $22.8M ($0.51 per share) in Q3 2023. Cash position of $59.1M is expected to fund operations into Q3 2025. The company expects top-line data from Phase 2 CALLIPER trial in April 2025, with ENSURE-1 completion anticipated in Q2 2026 and ENSURE-2 in H2 2026.
Immunic (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has scheduled its Q3 2024 financial results announcement and corporate update for November 7, 2024, before U.S. markets open. The company will host a webcast at 8:00 am ET on the same day. Participants can register through the company's website or via the provided Zoom link, and a replay will be available approximately one hour after the event.
Immunic Inc (Nasdaq: IMUX) has announced its participation in several key conferences during November 2024. The company will attend BIO-Europe in Stockholm (Nov 4-6) for partnering activities. At the Immuno-Mediated Diseases of the GI Tract Symposium in Florence (Nov 8-9), Dr. Sara Elhag will present data from their phase 1b trial of IMU-856, targeting SIRT6 in celiac disease patients. The company will also participate in the Jefferies London Healthcare Conference (Nov 19-21) and the Virtual Investor Summit (Nov 21), where CEO Daniel Vitt will present a company overview and conduct one-on-one meetings.
Immunic, Inc. (Nasdaq: IMUX) announced a positive outcome from the interim futility analysis of its phase 3 ENSURE program, testing vidofludimus calcium for relapsing multiple sclerosis (RMS). An Independent Data Monitoring Committee (IDMC) recommended continuing the trials without changes, confirming that predetermined futility criteria were not met.
Key points:
- The ENSURE program remains on track for completion in 2026
- The IDMC's recommendations suggest the trial design and assumptions are in line with observed data
- Immunic remains blinded to all data
- The ENSURE program consists of two identical phase 3 trials, each enrolling about 1,050 adult RMS patients
- The primary endpoint is time to first relapse up to 72 weeks
- Completion of ENSURE-1 is expected in Q2 2026, and ENSURE-2 in H2 2026
Immunic, Inc. (Nasdaq: IMUX) presented key data on vidofludimus calcium (IMU-838) at the 40th Congress of ECTRIMS, highlighting its potential in multiple sclerosis (MS) treatment. The data included:
1. Neurofilament light chain (NfL) reduction: In the CALLIPER trial interim analysis, vidofludimus calcium reduced serum NfL levels by 22.4% compared to placebo after 24 weeks, consistent across progressive MS subtypes.
2. Potential fatigue reduction: Clinical signals suggest vidofludimus calcium may reduce fatigue in MS patients by preventing Epstein-Barr virus reactivation.
3. Neuroprotective effects: Preclinical data showed improved neuronal survival, likely driven by Nurr1 activation.
4. T cell modulation: Vidofludimus calcium reduced or prevented development of pathogenic peripheral T helper cells in preclinical experiments.
The company expects to release CALLIPER top-line data in April 2025.
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