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) has appointed Inderpal Singh as General Counsel, effective June 1, 2021. Singh brings over 20 years of legal expertise, having previously served as the Global Legal Head of Biopharma at Sandoz and holding various roles at Merck and Biogen. He will oversee legal and compliance matters to advance Immunic's pipeline of selective oral immunology therapies, including IMU-838, targeting chronic inflammatory diseases. His experience in regulatory affairs and commercialization is expected to support the company's growth.
Immunic, Inc. (Nasdaq: IMUX) reported Q1 2021 financial results with a net loss of approximately $34.5 million, or $1.63 per share. R&D expenses rose to $11.5 million, driven by costs for ongoing clinical trials, while G&A expenses increased to $20.9 million, primarily due to a royalty settlement. Key developments included positive interim data from the phase 2 EMPhASIS study of IMU-838 for RRMS, confirming a 30 mg dose for future phase 3 trials. The company plans to initiate additional trials for IMU-838 in PSC and UC, with expectations to file an IND application in the U.S. soon.
Immunic, Inc. (Nasdaq: IMUX) reported interim data from its phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis (RRMS). The data indicate that 30 mg once daily is the most suitable dosage for future trials. Highlights include a dose-response pattern and comparable efficacy between 30 mg and 45 mg previously studied doses. The company plans to submit an Investigational New Drug application directly to the FDA, with phase 3 initiation expected in H2 2021. Current results support the viability of IMU-838 as a promising oral therapy for RRMS.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in key scientific and investor conferences in April 2021. Notably, at the 2021 Virtual AAN Annual Meeting, Robert J. Fox, M.D., will present data from the phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis. The B. Riley Neuroscience Conference will also feature Dr. Daniel Vitt discussing Immunic's developments. Furthermore, Dr. Vitt will present on IMU-838's application in COVID-19 at the German Corona Showcase 2021. Access to presentation materials will be available on Immunic's website.
On March 31, 2021, Immunic (Nasdaq: IMUX) announced an agreement with 4SC AG to settle a 4.4% royalty on net sales of their lead program, IMU-838, for $17.25 million. Payment will be made 50% in cash and 50% in stock. This acquisition eliminates remaining payment obligations and allows Immunic to capture 100% of future sales from IMU-838, which targets conditions like multiple sclerosis and ulcerative colitis. The company plans to initiate a phase 3 trial later in 2021, furthering its potential market growth.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on immunology therapies, announced its participation in several industry and investor conferences in March 2021. Key events include the 2nd Annual European HealthTech CEO Forum on March 8-9, where CEO Daniel Vitt will discuss IMU-838's potential for COVID-19. Other conferences include the H.C. Wainwright Global Life Sciences Conference, BioCapital Europe 2021, and the 33rd Annual Roth Conference. Participants can view presentations on Immunic's website.
Immunic, Inc. (Nasdaq: IMUX) reported its financial results for the year ending December 31, 2020, highlighting significant clinical milestones. The company demonstrated clinical activity of its lead asset, IMU-838, in COVID-19 patients and reported positive outcomes in a phase 2 trial for primary sclerosing cholangitis. R&D expenses rose to $38.6 million, while G&A expenses decreased to $10.3 million. The net loss was approximately $44 million. Immunic ended 2020 with $127.5 million in cash, projected to fund operations into mid-2022.
Immunic, Inc. (Nasdaq: IMUX) announced promising data from a phase 2 proof-of-concept trial for IMU-838, targeting primary sclerosing cholangitis (PSC). Out of 18 enrolled patients, 11 completed the treatment. Statistically significant reductions in serum alkaline phosphatase (ALP) were noted, with 27.3% of evaluable patients achieving a >25% reduction. The drug demonstrated safety with rare mild adverse events. Although limited by COVID-19 challenges, the results suggest further development for IMU-838 in treating PSC is warranted, with potential for additional trials.
Immunic, Inc. (Nasdaq: IMUX) reported positive results from its phase 2 CALVID-1 trial evaluating IMU-838, a selective oral DHODH inhibitor, for hospitalized COVID-19 patients. The analysis included data from 204 patients, demonstrating low rates of invasive ventilation (<1%) and mortality (<2%). IMU-838 showed clinical activity, with a higher proportion of patients recovering by day 28 (71.3% vs. 66.7% placebo). The drug was found to be safe and well-tolerated, with notable benefits for high-risk and elderly populations. A full analysis of all 223 patients is expected in Q2 2021.
Immunic, Inc. (Nasdaq: IMUX) announced CEO Daniel Vitt will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on February 25, 2021, at 10:00 am ET. A live audio webcast will be accessible on Immunic's website, with an archived version available for 90 days post-conference. Immunic focuses on developing selective oral therapies for chronic inflammatory and autoimmune diseases, including multiple sclerosis and ulcerative colitis. Its lead program, IMU-838, has shown positive results in clinical trials.