– At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW –
– Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years –
NEW YORK, June 24, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today reported new long-term open-label extension (OLE) data from its phase 2 EMPhASIS trial of lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS).
– Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 –
– Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential –
– New CALLIPER Data Regarding Time to 24-Week Confirmed Disability Worsening Shows Substantial and Medically Relevant Reductions for Vidofludimus Calcium Over Placebo in the Overall Study Population and Major Disease Subtypes –
NEW YORK, June 3, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the closing of its previously announced underwritten public offering of (i) pre-funded warrants to purchase shares of common stock (the "Pre-Funded Warrants"), (ii) series A warrants to purchase shares of common stock (or pre-funded warrants) (the "Series A Warrants"), and (iii) series B warrants to purchase shares of common stock (or pre-funded warrants) (the "Series B Warrants").
NEW YORK, June 2, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following investor, scientific and industry conferences in June:
June 3-5: Jefferies Healthcare Conference. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will present a company overview on Thursday, June 5, 2025 at 4:55 pm ET at this conference in New York. A webcast will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Dr. Vitt, Jason Tardio, President and Chief Operating Officer, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Jefferies representative or Jessica Breu at: jessica.breu@imux.com.NEW YORK, May 29, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the pricing of an underwritten public offering of (i) pre-funded warrants to purchase shares of common stock (the "Pre-Funded Warrants"), (ii) series A warrants to purchase shares of common stock (or pre-funded warrants) (the "Series A Warrants"), and (iii) series B warrants to purchase shares of common stock (or pre-funded warrants) (the "Series B Warrants"). The combined public offering price of one Pre-Funded Warrant, one Series A Warrant, and one Series B Warrant, which are being sold together but are immediately seperable, is $0.7499. The Pre-Funded Warrants will be immediately exercisable, and may be exercised at any time after their original issuance. The Series A Warrants will be immediately exercisable any time before December 31, 2025. The Series B Warrants will be exercisable beginning on October 1, 2025, or earlier if certain thresholds are met, until five years from the date of issuance. The Series A and B Warrants will immediately expire in proportion to the extent that the corresponding pre-funded warrant offered hereby is exercised on or prior to September 30, 2025, subject to certain exceptions.
NEW YORK, May 28, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has commenced an underwritten public offering of (i) pre-funded warrants to purchase shares of common stock, (ii) Series A warrants to purchase shares of common stock (or pre-funded warrants) expiring on December 31, 2025, (iii) and Series B warrants to purchase shares of common stock (or pre-funded warrants) expiring five years following the issuance date. The Series A and B warrants will immediately expire in proportion to the extent that the corresponding pre-funded warrant offered hereby is exercised on or prior to September 30, 2025, subject to certain exceptions. All of the securities to be sold in the proposed offering will be offered by Immunic. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.
NEW YORK, May 2, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in May:
May 3-6: Digestive Disease Week (DDW). Two abstracts discussing Immunic's phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, have been accepted for poster presentations at this conference in San Diego, CA.Poster Title: IMU-856 vs. Placebo Efficacy Effects in Celiac Disease Patients Are Independent of Q-MARSH Scale at BaselineAbstract ID: 4216653Poster Number: Tu1329Presenting Author: Indira Pichetto Olanda, M.D., Associate Medical Manager, ImmunicSession: Enteropathies — Celiac, Gluten Related and EnvironmentalSession Date: Tuesday, May 6, 2025Session Time: 12:30 – 1:30 pm PDTPoster Title: Influence of Gut Epithelial Condition on the Pharmacokinetic Properties of IMU-856, an Oral Regulator of Barrier Function for the Treatment of Celiac DiseaseAbstract ID: 4219364Poster Number: Tu1344Presenting Author: Jacques Arend, M.D., Head of Clinical Pharmacology, ImmunicSession: Enteropathies — Celiac, Gluten Related and EnvironmentalSession Date: Tuesday, May 6, 2025Session Time: 12:30 – 1:30 pm PDTMay 13-15: Clinical Trial Supply Forum 2025. Kimi Oanh Le, Head of Clinical Trial Supply at Immunic, will discuss the clinical trial supply chain challenges working across the Middle East and North Africa (MENA) at this forum in Brussels, Belgium.Presentation Type: Case StudyCase Study Title: Immunic Therapeutics Supply Chain Challenges Working Across MENADate: Wednesday, May 14, 2025Time: 10:40 am CEST (4:40 am EDT)May 28-31: Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025. Members of Immunic's management, medical and preclinical teams will attend this meeting in Phoenix, AZ. The team will be available throughout the event at booth #911. Additionally, preclinical data highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), will be presented in a poster presentation.Poster Title: In Preclinical Models, Vidofludimus Calcium Exhibits Potential Neuroprotective Effects in Multiple Sclerosis by Modulating Nurr1Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, ImmunicAbstract ID: 10271Poster Board Label: NDM01Date: Thursday, May 29, 2025Time: 5:00 – 7:00 pm MST– Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events by 20% in Overall Study Population Compared to Placebo; Even More Prominent 30% Reduction in High Unmet Need Population of Primary Progressive Multiple Sclerosis –
– Showed Consistent Reduction of Disability Worsening in Subpopulations Without Inflammatory Lesions at Baseline in Overall Study Population; Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events in Patients Without Gadolinium-Enhancing Lesions at Baseline by 29% Compared to Placebo –
NEW YORK, April 10, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the closing of its previously announced registered direct offering of 5,666,667 shares of its common stock at a price of $0.90 per share, led by Aberdeen Investments. All securities in the offering were sold by Immunic.
The gross proceeds from the offering were approximately $5.1 million before deducting commissions and offering expenses. The offering closed on April 10, 2025.
NEW YORK, April 9, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the pricing of a registered direct offering of 5,666,667 shares of its common stock at the market under Nasdaq rules at a price of $0.90 per share, led by Aberdeen Investments. All securities in the offering are being sold by Immunic.
NEW YORK, April 1, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in April:
April 5-9: American Academy of Neurology (AAN) 2025 Annual Meeting. Members of Immunic's management, medical and preclinical teams will attend this meeting in San Diego, California. The team will be available throughout the event at booth #2233.April 9-10: German Biotech Days 2025 (Deutsche Biotechnologietage, DBT 2025). Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present "Vidofludimus Calcium – Designed to Combine the Best of Two Worlds: Neuroprotection and Relapse Prevention," highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as well as Immunic's journey from company foundation to late-stage clinical trials, during a symposia at this conference in Heidelberg, Germany. The presentation will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Symposia: All Grown Up? Mature Biotech Companies Present their ProgressSession Date: Wednesday, April 9, 2025Session Time: 2:20-3:30 pm CET (8:20-9:30 am ET)Session Location: Saal 2NEW YORK, March 3, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and investor conferences in March:
March 4-7: 34th Annual Meeting of the Society for Virology. Two abstracts have been accepted for abstract talk presentations at this conference in Hamburg, Germany. The presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Title: Orally Bioavailable RORγ/DHODH Dual Host-Targeting Small Molecules with Broad-Spectrum Antiviral ActivityPresenting Author: Friedrich Hahn, Ph.D., Institute for Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, GermanyAbstract Talk: O 081Session: Antiviral therapy and resistance IDate: March 6, 2025Time: 9:30-9:45 am CET (3:30-3:45am ET)Title: Novel Vidofludimus-Based DHODH Inhibitors Containing Carboxylic Acid Bioisosters with Superior Broad-Spectrum Antiviral ActivityPresenting Author: Alexandra Herrmann, Ph.D., Manager Translational Pharmacology, ImmunicAbstract Talk: O 112Session: Antiviral therapy and resistance IIDate: March 7, 2025Time: 11:00-11:15am CET (5:00-5:15am ET)– Vidofludimus Calcium's Activation of Nurr1 Reduces Neuronal Loss and Injury Directly and Indirectly By Decreasing Microglial Activations in Preclinical Models –
– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
NEW YORK, Feb. 26, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of data on its lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025, taking place from February 27 to March 1, in West Palm Beach, Florida.
– New Data Suggests that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –
– Dose-Dependent Increase of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –
– Dose-Dependent Reduction of Body Weight Gain and Food Consumption Observed in Preclinical Study –
– Webcast to be Held Today, February 20 at 8:00 am ET –
NEW YORK, Feb. 20, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from its phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
NEW YORK, Feb. 4, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following investor and scientific conferences in February:
February 10-11: BIO CEO & Investor Conference 2025. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in one-on-one meetings at this conference, taking place in New York. Interested parties can request a meeting through the BIO Partnering™ system or contact Jessica Breu at: jessica.breu@imux.com.February 11-12: Oppenheimer 35th Annual Healthcare Life Sciences Conference. Dr. Vitt will participate in a fireside chat at this virtual conference on Wednesday, February 12 at 1:20 pm ET. A webcast will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Additional team members, including Jason Tardio, President and Chief Operating Officer, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also be in attendance to participate in one-on-one meetings at the conference. To schedule a meeting, please contact your Oppenheimer representative or Jessica Breu at: jessica.breu@imux.com.February 19-22: 19th Congress of ECCO (European Crohn's and Colitis Organisation). Members of Immunic's medical, clinical and preclinical teams will attend this congress in Berlin, Germany, where two abstracts discussing clinical and preclinical data on IMU-856, Immunic's orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), will be presented as digital oral presentations. The presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Presentation Title: Promising Effects of IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration - Biomarker Findings from a Phase 1 Clinical StudyPresenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, ImmunicAbstract Number: EC25-1515Presentation Number: DOP012Presentation Time: 5:57 pm – 6:03 pm CETSession Name: Digital Oral Presentation (DOP) Session 2: Clinical Trials IISession Date: February 20, 2025Session Hall: A8Presentation Title: Preclinical Characterization of IMU-856, an Orally Available Epigenetic Modulator of Gut Barrier Function and RegenerationPresenting Author: Martina Wirth, Ph.D., Senior Manager Translational Pharmacology, ImmunicAbstract Number: EC25-1096Presentation Number: DOP116Presentation Time: 6:27 pm – 6:33 pm CETSession Name: Digital Oral Presentation (DOP) Session 13: Basic Science in IBDSession Date: February 21, 2025Session Hall: A1February 25-27: 7th Neuroimmunology Drug Development Summit. Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present an overview on Immunic's lead asset, vidofludimus calcium (IMU-838), at this summit in Boston. The presentation will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Presentation Title: Vidofludimus Calcium (IMU-838) Combines the Best of Two Worlds: Neuroprotection and Relapse Prevention in Multiple SclerosisPresentation Date: Thursday, February 27, 2025Presentation Time: 12:10 pm ETFebruary 27 - March 1: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. Members of Immunic's medical, clinical and preclinical teams will attend this meeting in West Palm Beach, Florida. Two abstracts have been accepted for poster presentations, which will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, the team will be available throughout the event at booth #322.Poster Title: Baseline Characteristics Across Major Clinical Trials in Progressive Multiple Sclerosis: Insights from ORATORIO, EXPAND, MS-STAT2, HERCULES, and CALLIPERPresenting Author: Robert J. Fox, Staff Neurologist, Mellon Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, OhioAbstract Number: 452Poster Number: P102Poster Session: 1Session Date: Thursday, February 27, 2025Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm; odd-numbered posters present from 6:45-7:30 pm)Poster Title: Vidofludimus Calcium Shows a Potential Neuroprotective Function in Multiple Sclerosis through its Activity on Nurr1 in Preclinical ModelsPresenting Author: Evelyn Peelen, Ph.D., Head of Research, ImmunicAbstract Number: 427Poster Number: P317Poster Session: 2Session Date: Friday, February 28, 2025Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm; odd-numbered posters present from 6:45-7:30 pm)– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
– Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 –
– Strengthened Management Team and Board of Directors with Key Hires –
– Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche –
NEW YORK, Nov. 26, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a fireside chat on Thursday, December 5, 2024, at 11:30 am ET, during the Piper Sandler 36th Annual Healthcare Conference, taking place December 3-5, 2024, in New York.
Dr. Vitt, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Piper Sandler representative or Jessica Breu at: jessica.breu@imux.com.
– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients –
NEW YORK, Nov. 13, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, "Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial." It can be accessed through the following link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.
– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 –
– Webcast to be Held Today, November 7, at 8:00 am ET –
NEW YORK, Nov. 7, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a corporate update.
– Webcast to be Held at 8:00 am ET on November 7, 2024 –
NEW YORK, Oct. 31, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.
Die hier zur Verfügung gestellten Informationen unterliegen keiner redaktionellen Bearbeitung. Die Aufbereitung erfolgt vollautomatisch und wird durch Zusatzinformationen und weiterführende Recherchemöglichkeiten angereichert. Ziel der Inhalte ist die schnelle und unkomplizierte Versorgung der Informationssuchenden mit den für sie relevanten Informationen. Durch eine Rückverlinkung auf den Informationsanbieter und -eigentümer ist sichergestellt, dass die hier aufbereiteten Daten bei Bedarf mit den Quellinformationen abgeglichen werden können. Das Newsboard zeigt keine Informationen in Echtzeit. Diese bitten wir bei Bedarf beim Börsenbetreiber abzurufen. Es besteht kein Anspruch auf Vollständigkeit. Hochverfügbarkeit kann nicht gewährleistet werden. Sollten Sie Fehler in der Funktionsweise bemerken, teilen Sie uns diese über das weiter unten befindliche Formular "Report a Bug" mit.
RAW DATA PROCESSING bedeutet, dass Rohdaten verarbeitet werden, ohne den Inhalt zu verändern. Um die Interpretation der Information im Sinne der Nutzbarkeit zu verbessern, werden die Daten ergänzt.
Hinweis: Über das Newswire-Crosslink-Panel im oberen Bereich gelangen Sie schnell und bequem zu weiteren Informationsquellen. Im Terminalview sind die Nachrichten auf Unternehmensebene gefiltert und ermöglich darüber gezielte Recherchen.
Wir bedanken uns im Namen der Trading-Community bei den Betreibern der Handelsplätze für die Bereitstellung von Informationsdiensten.