Immunic, Inc. develops novel oral therapies for neurologic diseases, with a lead program, vidofludimus calcium (IMU-838), focused on multiple sclerosis. Company news commonly covers clinical and scientific presentations, patent protection for vidofludimus calcium, pipeline updates, and corporate communications tied to its late-stage development strategy.
Updates also include governance changes, board and executive appointments, Nasdaq listing compliance, capital actions such as its reverse stock split, and investor conference participation. Immunic's pipeline references additional earlier-stage programs, including IMU-856 and IMU-381, tied to neurodegenerative, chronic inflammatory, and autoimmune-related disease areas.
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.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, announced its participation in key scientific and investor conferences in September 2020. From September 11-13, Immunic will present data from the phase 2 EMPhASIS trial of IMU-838 at the MSVirtual2020, showcasing results in patients with relapsing-remitting multiple sclerosis. Additionally, on September 23, CEO Daniel Vitt will engage in a fireside chat during the Jefferies Next Generation IBD Therapeutics Virtual Summit. For more information, visit ir.imux.com/events-and-presentations.
Immunic, Inc. (Nasdaq: IMUX) has initiated its phase 1 clinical program for IMU-856, a novel oral therapy aimed at restoring intestinal barrier function and targeting gastrointestinal diseases. The first healthy volunteer has been dosed, marking progress toward evaluating the drug's potential as a treatment option for conditions like IBS-D, ulcerative colitis, and Crohn's disease. The program is designed to assess safety and pharmacokinetics in healthy subjects before moving to patients. This development follows promising preclinical data and a license agreement with Daiichi Sankyo.