Welcome to our dedicated page for Inflarx news (Ticker: IFRX), a resource for investors and traders seeking the latest updates and insights on Inflarx stock.
InflaRx N.V. (Nasdaq: IFRX) is a biopharmaceutical company that regularly issues news on its clinical programs targeting the complement system, particularly the C5a/C5aR axis. Company updates highlight progress with its oral C5a receptor inhibitor izicopan (also referenced as INF904) and its intravenously delivered anti-C5a monoclonal antibody vilobelimab, including GOHIBIC (vilobelimab) for SARS-CoV-2-induced acute respiratory distress syndrome in the European Union.
News about InflaRx often covers clinical trial milestones, such as Phase 2a data in hidradenitis suppurativa and chronic spontaneous urticaria for izicopan, as well as analyses of Phase 3 data for vilobelimab in pyoderma gangrenosum. Releases also describe regulatory interactions, including anticipated discussions with the U.S. Food and Drug Administration, and strategic decisions about prioritizing resources toward izicopan and adjusting spending on GOHIBIC (vilobelimab).
Investors following IFRX news can expect announcements on clinical data readouts, participation in healthcare and investor conferences, and business updates related to funding, cash runway and partnering activities. InflaRx’s communications have included information on BARDA-supported studies in acute respiratory distress syndrome, co-development activities for an anti-C5a antibody in China, and notices regarding Nasdaq listing requirements.
This news feed aggregates InflaRx’s press releases and related coverage so readers can review clinical developments, regulatory updates and corporate actions in one place. For those tracking complement-targeted therapeutics, IFRX news provides insight into how the company is advancing its C5a and C5aR inhibitor programs across dermatologic and respiratory indications and how it is aligning its strategy and capital allocation with these priorities.
InflaRx N.V. (Nasdaq: IFRX) announced a pause in its Phase III trial for vilobelimab in treating hidradenitis suppurativa (HS) after receiving unexpected feedback from the FDA. The FDA recommended using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint, differing from prior guidance where InflaRx proposed a modified HiSCR. This new feedback emerged almost three months post-protocol submission. The FDA did not issue a clinical hold, and InflaRx plans to clarify the FDA's advice moving forward.
InflaRx (Nasdaq: IFRX) announced the continuation of a Phase II clinical trial for vilobelimab, an anti-inflammatory drug, in combination with pembrolizumab for cutaneous squamous cell carcinoma (cSCC). Three patients have safely completed 36 days of the first dosing cohort, prompting the Steering Committee to open enrollment for the second dosing cohort. Ongoing enrollment in vilobelimab monotherapy also shows no safety concerns. The trial aims to evaluate the drug's safety and effectiveness, with interim results expected in Q1 2023.
InflaRx N.V. (Nasdaq: IFRX) will present at the 11th Annual SVB Leerink Healthcare Conference, scheduled for February 14-18, 2022. CFO Thomas Taapken and Chief Strategy Officer Jordan Zwick will engage in a fireside chat on February 17 at 10:40 am EST. The event will be accessible via a live audio webcast on the InflaRx website. InflaRx focuses on targeting the complement system to develop anti-inflammatory therapeutics, specializing in C5a and C5aR inhibitors for various autoimmune diseases.
InflaRx N.V. (Nasdaq: IFRX) announced the initiation of regulatory discussions for its Phase I program concerning INF904, a novel oral small molecule inhibitor targeting C5aR. The company plans to commence the first-in-human study in the latter half of 2022. Recently granted a composition of matter patent for INF904, the drug has demonstrated strong anti-inflammatory effects in preclinical studies, showcasing a favorable safety profile and improved drug interactions compared to existing inhibitors. INF904 aims to treat chronic autoimmune and inflammatory diseases with ease of oral administration.
InflaRx N.V. (Nasdaq: IFRX) has announced its participation in key investor conferences, including the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, and the H.C. Wainwright BioConnect Conference starting January 10, 2022. The company will also host a virtual R&D event on February 3, 2022, focused on vilobelimab for Hidradenitis Suppurativa, detailing study design and endpoints for its Phase III trial. InflaRx aims to develop innovative anti-inflammatory therapeutics targeting the complement system.
InflaRx N.V. (Nasdaq: IFRX) announced the initiation of a Phase III trial for vilobelimab targeting hidradenitis suppurativa (HS) patients with active draining tunnels. The study will use a new primary endpoint, the modified HiSCR, to assess the reduction of inflammatory nodules, abscesses, and draining tunnels. Patient enrollment is set to commence in Q2 2022, following FDA support for the trial design. A virtual R&D event scheduled for February 3, 2022, will provide further insights into the study. Over 300 individuals have previously received vilobelimab in clinical trials.
InflaRx (Nasdaq: IFRX) announced encouraging results from its Phase II IXCHANGE study of vilobelimab in ANCA-associated vasculitis (AAV). The study showed that vilobelimab matched the efficacy of standard glucocorticoids while significantly reducing their usage and associated toxicity. In total, 57 patients participated in the trial, demonstrating high clinical response rates across treatment groups. Notably, vilobelimab alone had the least treatment-emergent adverse events. The company plans to consult regulatory authorities to discuss the next steps for vilobelimab's development.
InflaRx (Nasdaq: IFRX) will present a corporate overview at the H.C. Wainwright 7th Annual Israel Conference on November 15, 2021, at 8:00 am EST/2:00 pm CET. The presentation will be accessible through a live webcast on the company's website. InflaRx focuses on developing anti-inflammatory therapeutics targeting the complement system, with a special emphasis on its proprietary anti-C5a technology. Founded in 2007, the company operates in Germany and the USA.
InflaRx reported positive developments for vilobelimab, focusing on treatment for Hidradenitis Suppurativa (HS) and Pyoderma Gangraenosum (PG). The FDA endorsed a new primary endpoint for HS, while in PG, 6 of 7 patients achieved clinical remission in a Phase IIa study. The company secured a €43.7 million grant from the German government to advance vilobelimab for severe COVID-19. As of September 30, 2021, InflaRx had approximately €120.6 million in cash and equivalents, despite a net loss of €33 million for the nine months ended. Topline COVID-19 data is expected in Q1 2022.
InflaRx (Nasdaq: IFRX) announced that Prof. Niels C. Riedemann, CEO and Founder, will present a corporate overview during a fireside chat at the Credit Suisse 30th Annual Healthcare Conference. The session is scheduled for November 10, at 9:40 am EST/3:40 pm CET, and will be accessible via a live webcast on the InflaRx website. InflaRx focuses on developing anti-inflammatory therapeutics by targeting the complement system, specifically inhibitors of C5a, which is crucial in autoimmune and inflammatory diseases.