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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 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.
Immunic, Inc. (Nasdaq: IMUX) has priced a public offering of 4,500,000 shares of common stock at $10 per share, aimed at raising approximately $45 million before expenses. The offering includes a 30-day option for underwriters to purchase an additional 675,000 shares. Proceeds will fund the clinical development of lead candidates IMU-838, IMU-935, and IMU-856. The closing is anticipated on July 19, 2021, pending customary conditions. Piper Sandler is the sole book-runner, with co-managers including Ladenburg Thalmann & Co., Roth Capital Partners, and Aegis Capital Corp.
Immunic, Inc. (Nasdaq: IMUX) announced a proposed underwritten public offering of its common stock, intending to use net proceeds for ongoing clinical development of its product candidates, IMU-838, IMU-935, and IMU-856. The offering is subject to market conditions, with a possibility of underwriters purchasing up to an additional 15% of shares. Piper Sandler is the sole book-runner for the offering. The securities are being offered under an effective shelf registration statement filed with the SEC.
Immunic, Inc. (Nasdaq: IMUX) hosted a virtual R&D Day on July 12, 2021, discussing new preclinical data for their drug IMU-935, an inverse agonist of RORγt. The data demonstrate IMU-935's ability to selectively inhibit Th17 differentiation without affecting thymocyte development, potentially mitigating safety risks seen in other therapies. Full pharmacokinetic and safety data from an ongoing Phase 1 trial in Australia were also presented, indicating no significant safety findings to date. Immunic plans to extend the trial to include psoriasis patients and is preparing for a Phase 1 trial for metastatic castration-resistant prostate cancer.
Immunic, Inc. (Nasdaq: IMUX) has received FDA clearance for its Investigational New Drug (IND) application for the phase 3 ENSURE program of IMU-838, a selective oral DHODH inhibitor, targeting relapsing-remitting multiple sclerosis (RRMS). The ENSURE program includes two multicenter trials assessing IMU-838's safety and efficacy compared to placebo. Additionally, an IND was cleared for a phase 2 CALLIPER trial for progressive multiple sclerosis (PMS). IMU-838 shows potential to differentiate itself in the market if both trials yield positive results.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in several key conferences in July, highlighting its focus on immunology therapies for chronic diseases. Key events include the 6th World Psoriasis & Psoriatic Arthritis Conference (June 30-July 3), where Dr. Thomas M. Polasek will present the initial clinical results of IMU-935, an oral therapy for psoriasis. Additionally, Immunic will attend the 16th Congress of ECCO (July 2-3) and the Ladenburg Thalmann Healthcare Conference (July 13-14), where Dr. Daniel Vitt will provide a company overview. More information is available on their website.
Immunic, Inc. (Nasdaq: IMUX), a biopharmaceutical company, announced its participation in key industry conferences in June 2021. The events include the BIO Digital from June 14-18, where one-on-one meetings will be held, and the JMP Securities Life Science Conference on June 16-17, featuring a fireside chat with CEO Daniel Vitt on June 17 at 11:30 am ET. Immunic is focused on developing therapies for chronic inflammatory and autoimmune diseases, including its lead program, IMU-838, targeting various conditions.
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.
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