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Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis
Study Meets Primary and Key Secondary Endpoints with High Statistical Significance Indicating Activity for IMU-838 in Relapsing-Remitting Multiple Sclerosis Statistically Significant Reduction of 62% and 70% in Combined Unique Active Magnetic Resonance Imaging Lesions in 45mg and 30mg Patient Cohorts, As Compared to Placebo Data Supports Previously Observed Favorable Safety Profile of IMU-838 in Relapsing-Remitting Multiple Sclerosis Patient Population Company Also Reports Second Quarter 2020 Financial Results With $48.6 Million in Cash and Cash Equivalents Conference Call and Webcast to be Held on August 3, 2020 at 8:30am ET Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune…
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Immunic, Inc. Announces First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment of Patients with Moderate-to-Severe COVID-19
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced enrollment of the first patients in an investigator-sponsored phase 2 clinical trial of the company’s selective oral DHODH inhibitor, IMU-838, for the treatment of patients with coronavirus disease 2019 (COVID-19). The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy and safety of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir (Tamiflu®), in approximately 120 adult patients with moderate-to-severe COVID-19. The IONIC trial has been set up with the support of the in-house Trial Management Unit (TMU) of the sponsor…
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Immunic, Inc. to Join Russell 3000® Index
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that the company is set to join the broad-market Russell 3000® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29, according to a final list of additions accessed on June 19. The annual reconstitution of the Russell indexes captures the 4,000 largest US stocks as of May 8, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell…
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Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced dosing of the first patients in its phase 2, CALVID-1 clinical trial of IMU-838, the company’s selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19), at several sites in different European countries. Patients will be enrolled at 10 to 35 centers in Germany, the United States and a half dozen European countries. CALVID-1 recently received regulatory allowance from the German health authority, BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), from the U.S. Food and Drug Administration (FDA) and from regulatory authorities in other European countries involved…
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Immunic, Inc. Announces Proposed Public Offering of Common Stock
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced it has commenced a public offering of shares of its common stock. Immunic intends to use the proceeds from the offering to fund the ongoing clinical development of the Company’s three small molecule products: IMU-838, IMU-935 and IMU-856, and for other general corporate purposes, including to investigate IMU-838, the Company’s lead asset, as a potential oral treatment option for COVID-19. Roth Capital Partners is acting as a placement agent in connection with the offering. The shares of common stock will be offered pursuant to a shelf…
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Immunic, Inc. Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
Immunic, Inc. (Nasdaq: IMUX),a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced receipt of regulatory allowance from the U.S. Food and Drug Administration (FDA) to initiate its phase 2, CALVID-1 clinical trial of IMU-838, the company’s selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19) at centers in the United States. CALVID-1 received regulatory allowance from the German health authority, BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), on May 13, 2020 and has subsequently also received regulatory allowance in other European countries involved in the study. It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with…
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Immunic, Inc. to Host Virtual R&D Day Today, May 19, 2020
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, announced that it will host a virtual R&D Day today, May 19, 2020, from 9:00 am to 1:00 pm ET. Immunic’s management and invited key opinion leaders, specializing in multiple sclerosis and inflammatory bowel disease, will discuss today’s treatment options for, and the unmet medical needs of, chronic inflammatory and autoimmune diseases, as well as clinical progress of Immunic’s selective oral immunology programs and their potential advantages over the current treatment landscape. Management will also discuss the company’s coronavirus disease 2019 (COVID-19) program. During the event, Immunic will…
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Immunic, Inc. Receives First Regulatory Approval from German Health Authority BfArM to Initiate a Phase 2 Clinical Trial of its Selective Oral DHODH Inhibitor, IMU-838, in COVID-19 Patients
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that it has received first regulatory approval from Germany’s BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate a phase 2 clinical trial of its selective oral DHODH inhibitor, IMU-838, in coronavirus disease 2019 (COVID-19). The CALVID-1 study is a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in approximately 230 patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838. Dosing of the first patient is expected to occur later this month. Top-line data is expected to be available later this year.…
