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 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.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in key investor and scientific conferences in September 2021. From September 13-15, CEO Daniel Vitt will present at the H.C. Wainwright 23rd Annual Global Investment Conference, with an on-demand presentation available. Following this, Irina Betscheider will showcase IMU-935 at the 50th Annual ESDR Meeting between September 22-25. Lastly, Dr. Vitt will engage in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on September 28. For updates, visit www.imux.com.
Immunic, Inc. (Nasdaq: IMUX) reported Q2 2021 financial results, showing a net loss of approximately $17.9 million, or $0.82 per share. R&D expenses rose to $15.7 million, up from $10.0 million year-over-year. The company has received FDA clearance for phase 3 trials of IMU-838 in multiple sclerosis and expects to initiate these studies soon. Following a $45 million public offering, Immunic is well-positioned financially, anticipating funding through various clinical milestones into 2023. Upcoming data read-outs within the next year may significantly impact its stock performance.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical firm, announced its participation in two upcoming investor conferences in August 2021. The BTIG Virtual Biotechnology Conference will occur from August 9-10, with CEO Daniel Vitt speaking on August 9 at 11:30 am ET. The Wedbush PacGrow Healthcare Virtual Conference will follow on August 10-11, where Dr. Vitt will present on August 10 at 8:00 am ET. Webcasts of these events will be available on the company's website for 90 days.
On July 19, 2021, Immunic, Inc. (Nasdaq: IMUX) announced the closing of a public offering, selling 4,500,000 shares of common stock at $10.00 per share, raising $45.0 million. The funds will support the clinical development of IMU-838, IMU-935, and IMU-856, which target chronic inflammatory and autoimmune diseases. Piper Sandler acted as the sole book-runner for this underwritten offering. The securities were offered under a shelf registration statement effective since November 24, 2020.