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 participation in the Piper Sandler & Co. 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. CEO Daniel Vitt, Ph.D., will present a fireside chat available to registered attendees from November 22 to December 2. The presentation will also be accessible on Immunic's website under the 'Events and Presentations' section. Immunic focuses on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases, including lead product, vidofludimus calcium (IMU-838).
Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the first patient in its phase 3 ENSURE program for vidofludimus calcium (IMU-838) aimed at treating relapsing multiple sclerosis (RMS). This pivotal trial follows a supportive phase 2 trial and involves approximately 1,050 patients across more than 100 sites worldwide. The primary endpoint is the time to first relapse within 72 weeks. The company believes that the positive outcomes from earlier studies, including the phase 2 EMPhASIS trial, support its path toward regulatory approval.
Immunic, Inc. (Nasdaq: IMUX) reported its third-quarter financial results for 2021, revealing a net loss of $19.3 million, or $0.76 per share. The company highlighted major developments in its clinical pipeline, including the completion of patient enrollment in the CALDOSE-1 trial for IMU-838 in ulcerative colitis and the initiation of the CALLIPER trial in progressive multiple sclerosis. Financially, R&D expenses rose to $15.5 million, driven by increased clinical trial costs. The company ended the quarter with $110.4 million in cash, projected to cover operations into 2023.
Immunic, Inc. (Nasdaq: IMUX) will announce its third-quarter financial results for the period ending September 30, 2021, on November 4, 2021, prior to market open, followed by a webcast at 8:00 am ET. The company focuses on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases, including lead candidate IMU-838 for multiple sclerosis and other conditions. Immunic emphasizes that forward-looking statements involve risks and uncertainties which may affect future performance.
Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the final patient in its phase 2 CALDOSE-1 trial, assessing IMU-838 for moderate-to-severe ulcerative colitis (UC). This multicenter study has randomized 263 patients across 19 countries, focusing on efficacy and safety. Top-line data is expected in Q2 2022. Previous trials indicated a strong safety profile for IMU-838, making it a potential oral treatment alternative to biologics for UC patients. The trial's primary endpoint includes a composite of patient-reported outcomes and endoscopic assessments.
Immunic, Inc. (Nasdaq: IMUX) has enrolled its first psoriasis patient in Part C of the ongoing Phase 1 clinical trial for IMU-935, a selective RORγt inverse agonist. This double-blind, placebo-controlled trial aims to evaluate the safety and tolerability of IMU-935 in about 52 moderate-to-severe psoriasis patients. The trial will also assess various efficacy markers, including the Psoriasis Area and Severity Index (PASI). With over 10 participating sites in Australia and New Zealand, Immunic aims to offer a convenient oral treatment alternative for psoriasis patients.
Immunic, Inc. (Nasdaq: IMUX) has appointed Patrick Walsh as its new Chief Business Officer, effective immediately. In this role, Walsh will drive business development and strategic partnerships as part of the executive management team. He previously held senior roles at Akebia Therapeutics and AVEO Oncology, bringing substantial experience in building biopharmaceutical companies. Walsh aims to enhance Immunic's clinical programs, which include three candidates in development targeting chronic inflammatory and autoimmune diseases. His expertise is anticipated to strengthen Immunic's strategic position.
Immunic, Inc. (Nasdaq: IMUX) has commenced its phase 2 CALLIPER trial for IMU-838, a selective DHODH inhibitor, in patients with progressive multiple sclerosis (PMS). The multicenter trial aims to enroll approximately 450 patients across over 70 sites globally, with a primary focus on assessing brain volume change over 120 weeks. An interim analysis will evaluate serum neurofilament light chain levels, a potential indicator of neuroprotection. Successful outcomes could position IMU-838 favorably against other oral MS treatments, with phase 3 trials anticipated to start in Q4 2021.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in several significant scientific and investor conferences in October 2021. Key events include the B & T Cell-Mediated Autoimmune Disease Drug Development Summit on October 6-7, where IMU-838 will be presented, and the 37th Congress of ECTRIMS from October 13-15, featuring three accepted abstracts related to IMU-838. Following these, Immunic will join the Jefferies Next Generation IBD Therapeutics Summit on October 19 and the BIO-Europe Digital conference from October 25-28. Further details will be available on their website.
Immunic, Inc. (Nasdaq: IMUX) has signed an in-license agreement with the University Medical Center Goettingen to combine DHODH inhibitors and nucleoside analogues for treating COVID-19 and Influenza. Preclinical studies show Immunic's lead drug, IMU-838, significantly reduces SARS-CoV-2 replication in vitro. IMU-838 demonstrated up to 99.9% reduction in viral RNA, particularly effective against various variants. The company retains plans to pursue strategic options for this program. Upcoming data releases are expected for various ongoing clinical trials in 2021 and 2022.