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Immunic, Inc. (Nasdaq: IMUX) is a leading clinical-stage biopharmaceutical company focused on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases. With a dedicated pursuit of innovative solutions, Immunic is at the forefront of transforming therapeutic approaches for conditions such as relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis.
The company’s flagship product, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Currently in phase 2 and 3 clinical trials for various indications, IMU-838 has shown promising results in treating relapsing-remitting and progressive multiple sclerosis as well as moderate-to-severe ulcerative colitis. Additionally, IMU-838's mechanism as a nuclear receptor related 1 (Nurr1) activator underscores its potential neuroprotective effects.
Immunic is also advancing IMU-935, an inverse agonist of RORγt, and IMU-856, which aims to restore intestinal barrier function. IMU-856 is particularly notable for its innovative approach to gastrointestinal diseases, such as celiac disease and irritable bowel syndrome with diarrhea, by focusing on bowel architecture regeneration rather than immunomodulation.
Financially, Immunic has fortified its position with a significant private placement of up to $240 million, ensuring a strong cash runway through key clinical milestones. The company boasts robust partnerships with top-tier investors like BVF Partners and Janus Henderson Investors, reflecting strong market confidence in its clinical programs.
Highlighting its cutting-edge research, Immunic has presented pivotal data at prominent medical conferences, including the ACTRIMS Forum and has its results published in esteemed journals such as Neurology® Neuroimmunology & Neuroinflammation. These milestones not only solidify Immunic's scientific credibility but also mark significant progress in its clinical pipeline.
As of the latest updates, Immunic is gearing up for major clinical readouts, including the top-line data from the phase 2 CALLIPER trial expected in April 2025, and interim analyses from the phase 3 ENSURE trials anticipated in late 2024. The company’s achievements in these trials could potentially position vidofludimus calcium as a groundbreaking treatment option in the MS landscape.
Immunic continues to expand its patent portfolio, securing intellectual property rights that extend protection into the next two decades. This strategic move not only enhances its market exclusivity but also strengthens its competitive edge in the biotech industry.
Overall, Immunic, Inc. is poised for significant impact with its innovative oral therapies, backed by a strong financial foundation, strategic partnerships, and a commitment to addressing unmet medical needs in chronic inflammatory and autoimmune diseases.
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.
Immunic, Inc. (Nasdaq: IMUX) has announced a public offering of 5,000,000 shares at $18.00 each, aiming to raise approximately $90.0 million. The offering, subject to customary closing conditions, is expected to close on August 7, 2020. The net proceeds will fund the clinical development of key candidates, including IMU-838 for multiple sclerosis. The company has also granted underwriters a 30-day option to purchase an additional 750,000 shares. This offering follows a shelf registration statement with the SEC.
Immunic, Inc. (Nasdaq: IMUX) has announced plans to offer 5 million shares of common stock in an underwritten public offering, with underwriters granted an option for 750,000 additional shares. This is part of their ongoing efforts to support the development of selective oral immunology therapies for chronic inflammatory diseases. The offering's completion is dependent on market conditions. Joint bookrunning managers for this offering are SVB Leerink and Piper Sandler, with additional involvement from Wedbush PacGrow and Ladenburg Thalmann.
Immunic, Inc. (Nasdaq: IMUX) announced it will report its financial results for Q2 2020 on August 3, 2020, prior to U.S. market opening. The company is focused on oral therapies for chronic inflammatory and autoimmune diseases, including its lead product IMU-838, currently in phase 2 trials for multiple conditions, including COVID-19 and relapsing-remitting multiple sclerosis. A public conference call will follow the results announcement at 8:30 a.m. ET on the same day. Investors can access a live webcast or replay on Immunic's website.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, announced its participation in several investor conferences in August 2020. Management will engage in fireside chats at the BTIG Virtual Biotechnology Conference on August 10 at 3:30 pm ET, the Wedbush PacGrow Healthcare Virtual Conference on August 12 at 1:45 pm ET, and the Canaccord Genuity 40th Annual Growth Conference on August 12 at 11:00 am ET. Live webcasts will be available on the company’s website, with replays accessible for 90 days post-conference.
Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the first patients in the IONIC trial, a phase 2b clinical study for its oral DHODH inhibitor, IMU-838, targeting COVID-19. The trial aims to assess the efficacy and safety of IMU-838 combined with Oseltamivir in 120 adults with moderate-to-severe cases. IMU-838 has shown promising preclinical activity against SARS-CoV-2 and a favorable safety profile in earlier trials. The study is supported by the UHCW NHS Trust and LifeArc's £10 million initiative to expedite COVID-19 therapeutics.
Immunic, Inc. (Nasdaq: IMUX) announced its inclusion in the Russell 3000 Index effective June 29, 2020, following the annual reconstitution. This milestone reflects Immunic's progress in developing oral therapies for chronic inflammatory and autoimmune diseases, particularly its lead compound, IMU-838, which is undergoing four Phase 2 trials. Inclusion in the Russell 3000 Index enhances visibility and liquidity for the company's stock, with approximately $9 trillion in assets benchmarked against Russell indexes.
Immunic, Inc. (Nasdaq: IMUX) has begun dosing the first patients in its phase 2 CALVID-1 clinical trial for IMU-838, a selective oral DHODH inhibitor, aimed at treating moderate COVID-19. The trial, approved by regulatory bodies in Germany, the U.S., and other European countries, includes 230 hospitalized patients across 10 to 35 centers. Top-line data is expected later this year, with an interim analysis planned after 200 patients. IMU-838 has strong preclinical support and aims to show efficacy, safety, and tolerability, potentially leading to a phase 3 trial depending on interim results.
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