Welcome to our dedicated page for Immunic news (Ticker: IMUX), a resource for investors and traders seeking the latest updates and insights on Immunic stock.
Immunic, Inc. (Nasdaq: IMUX) generates frequent news as a late-stage biotechnology company advancing oral small molecule therapies for neurologic, gastrointestinal, and other chronic inflammatory and autoimmune diseases. Most company updates center on its lead asset, vidofludimus calcium (IMU-838), and the progression of multiple sclerosis clinical programs, as well as emerging data from its gastrointestinal pipeline candidates.
News items commonly highlight clinical trial milestones, such as completion of enrollment in the twin phase 3 ENSURE trials in relapsing multiple sclerosis, new long-term open-label extension data from the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis, and detailed results from the phase 2 CALLIPER trial in progressive multiple sclerosis. Releases also cover scientific presentations at major congresses, including oral and poster presentations at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), neuroimmunology meetings, and gastroenterology conferences.
Investors following IMUX news will also see intellectual property developments, such as Notices of Allowance from the U.S. Patent and Trademark Office for patents protecting vidofludimus calcium dose strengths and other aspects of its use in multiple sclerosis. Corporate updates regularly include financing announcements, quarterly financial results, and commentary on cash resources to support ongoing and planned studies.
For Immunic’s broader pipeline, news coverage includes analyses of IMU-856 in celiac disease and other gastrointestinal disorders, preclinical and early clinical findings related to intestinal barrier function and gut hormone levels, and the status of IMU-381 in preclinical testing. This news page aggregates these developments so readers can review clinical data readouts, conference participation, financing events, and regulatory and IP updates related to IMUX in one place.
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.
Immunic, Inc. (Nasdaq: IMUX) has successfully closed a public offering of 5,750,000 shares of common stock at $18.00 per share, raising approximately $103.5 million. This includes the full exercise of the underwriters' option to purchase an additional 750,000 shares. The proceeds will be utilized to advance clinical development for lead candidates IMU-838, IMU-935, and IMU-856, particularly for a potential Phase 3 trial of IMU-838 in relapsing-remitting multiple sclerosis. The offering was managed by SVB Leerink, with Wedbush PacGrow and Ladenburg Thalmann acting as co-managers.