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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, Inc. (Nasdaq: IMUX) has announced its selection for the NASDAQ Biotechnology Index, effective December 21, 2020. This index tracks biotechnology and pharmaceutical firms on NASDAQ, based on specific performance criteria. Immunic is focused on developing oral immunology therapies for chronic inflammatory and autoimmune diseases, with promising results from its phase 2 EMPhASIS trial of lead product IMU-838, targeting multiple sclerosis. The company also has ongoing trials for ulcerative colitis, Crohn's disease, and COVID-19, showcasing its commitment to advancing treatments in this sector.
Immunic, Inc. (Nasdaq: IMUX) announced participation in investor conferences from November 30 to December 3, 2020. Key events include the Piper Sandler 32nd Virtual Healthcare Conference, where CEO Daniel Vitt will engage in a fireside chat, and the Evercore ISI 3rd Annual HEALTHCONx Conference with a presentation on December 3. Archived replays will be available on Immunic's website. The company develops selective oral therapies for chronic inflammatory diseases, with promising results for its lead product, IMU-838.
Immunic, Inc. (Nasdaq: IMUX) has formed a Scientific-Medical Advisory Board (SAB) to enhance its clinical development efforts for its immunology therapies targeting chronic inflammatory and autoimmune diseases. The inaugural members include renowned experts like Drs. Fred D. Lublin and Bruce E. Sands, who will provide critical guidance on the company's pipeline, including the promising lead drug IMU-838, which has shown positive Phase 2 results for multiple sclerosis and is under investigation for ulcerative colitis and COVID-19.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in key investor and scientific conferences in November 2020. CEO Daniel Vitt will present at the Stifel 2020 Virtual Healthcare Conference on November 17 at 10:40 am ET, with a live audio webcast available. Additionally, CSO Hella Kohlhof will attend the Crohn's & Colitis Foundation's IBD INNOVATE Conference on November 17-18. Immunic focuses on developing oral immunology therapies for chronic diseases and has reported positive results from its phase 2 EMPhASIS trial of IMU-838.
Immunic, Inc. (Nasdaq: IMUX) announced third-quarter financial results for 2020, highlighting key developments in its pipeline. The company reported a net loss of $12.9 million, or $0.70 per share, with a cash position of $133.2 million expected to last through mid-2022. A major achievement was the successful phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis, demonstrating robust efficacy. Additionally, a financing agreement of up to €24.5 million supports the development of IMU-838 for COVID-19, with 200 patients enrolled in the phase 2 CALVID-1 trial.
Immunic, Inc. (Nasdaq: IMUX) has enrolled and randomized 200 patients in the CALVID-1 trial for its selective oral DHODH inhibitor, IMU-838, aimed at treating moderate COVID-19. This phase 2 trial is designed to assess the clinical activity of IMU-838, leveraging findings for potential future phase 3 trials. The anticipated main efficacy analysis results are expected in the first quarter of 2021. Previous interim safety results have supported the trial's continuation, highlighting broad antiviral activity against SARS-CoV-2.
The European Investment Bank (EIB) has signed a €24.5 million financing agreement with Immunic (Nasdaq: IMUX) to support its phase 2 CALVID-1 trial of IMU-838, aimed at treating moderate COVID-19. The funding will cover three tranches based on milestone completions and will also aid potential expansion into a phase 3 trial. IMU-838 has shown preclinical antiviral activity against SARS-CoV-2 and is also being evaluated for other chronic inflammatory diseases. The EIB's funding is part of the European Union's efforts to combat infectious diseases.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, will participate in two key scientific conferences in October 2020. From October 6-7, CEO Daniel Vitt will present at BioNJ's 10th Annual BioPartnering Conference, with a presentation available online. Additionally, from October 26-29, the management team will host one-on-one meetings at BIO-Europe® Digital 2020. Immunic is advancing treatments for chronic inflammatory diseases, including multiple sclerosis and ulcerative colitis, and recently reported positive phase 2 trial results for its lead product, IMU-838.
Immunic, Inc. (Nasdaq: IMUX) announced positive results from the interim safety analysis of its phase 2 CALVID-1 trial for IMU-838, a selective oral DHODH inhibitor, in moderate COVID-19 patients. The Independent Data Monitoring Committee found no safety concerns, recommending that the trial proceed without changes. Currently, 110 patients have been enrolled out of the targeted 230. Immunic plans to report unblinded interim efficacy and biomarker data later this year, potentially leading to a phase 3 trial expansion.
Immunic, Inc. (Nasdaq: IMUX) announced the release of full unblinded clinical data from the Phase 2 EMPhASIS trial for IMU-838, targeting relapsing-remitting multiple sclerosis (RRMS). The trial met primary and secondary endpoints with significant reductions in MRI lesions: 62% for 45mg and 70% for 30mg doses versus placebo. IMU-838 demonstrated a favorable safety profile, with adverse events similar to placebo. The results indicate potential for IMU-838 as a leading oral treatment for RRMS, with further discussions planned for a Phase 3 trial.
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