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InflaRx N.V. (NASDAQ: IFRX) is a clinical-stage biopharmaceutical company dedicated to discovering and developing inhibitors using C5a technology, primarily in Germany and the United States. The company focuses on targeting the complement activation factor known as C5a, an inflammatory mediator linked to various autoimmune and inflammatory diseases.
InflaRx's lead product candidate is vilobelimab (formerly known as IFX-1), a first-in-class, intravenously delivered anti-C5a monoclonal antibody. Vilobelimab has completed Phase IIb clinical trials for treating hidradenitis suppurativa, a rare and chronic inflammatory skin disease, as well as for ANCA-associated vasculitis, a life-threatening autoimmune condition, and pyoderma gangrenosum, a chronic inflammatory skin disorder. Additionally, the company is exploring vilobelimab’s potential in treating oncological diseases.
InflaRx is also developing IFX-2, another anti-inflammatory and autoimmune disease treatment currently in pre-clinical development. The company’s proprietary C5a/C5aR technology enables the creation of potent and specific inhibitors, positioning InflaRx as a pioneer in this niche therapeutic area.
The company has established a co-development agreement with Beijing Defe, enhancing its research and development capacity. InflaRx's innovative therapies aim to significantly improve patient outcomes in diseases with substantial unmet medical needs.
InflaRx has initiated dosing in its Phase 2a basket study for INF904, an oral C5aR inhibitor, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The study will enroll 75 patients, with 45 CSU patients receiving doses of 60mg or 120mg BID, and 30 HS patients randomized across 60mg, 90mg, or 120mg BID doses over 4 weeks. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits, with data expected in summer 2025. Each indication represents potential addressable markets of $1 billion or more. The company plans to use study results to design a larger Phase 2b trial by year-end 2025.
InflaRx received a positive CHMP opinion recommending marketing authorization for GOHIBIC® (vilobelimab) under exceptional circumstances for treating SARS-CoV-2-induced ARDS in adult patients. The treatment is specifically for patients receiving systemic corticosteroids and invasive mechanical ventilation. The European Commission is expected to issue marketing authorization within 67 days.
The recommendation is supported by Phase 3 PANAMO trial results, showing vilobelimab improved survival with a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. InflaRx plans to commercialize GOHIBIC® in Europe and is considering commercial distribution options with potential partners, noting this approach won't significantly impact cash burn rate.
InflaRx reported Q3 2024 financial results and business updates. Key developments include reaching a 30-patient recruitment milestone in Phase 3 vilobelimab trial for pyoderma gangrenosum, with interim analysis expected by end of Q2 2025. The company plans to initiate a Phase 2a trial for INF904 by year-end 2024, with first data readout expected in summer 2025. Cash position stands at €62.0 million, expected to fund operations into 2026. Revenue from GOHIBIC sales was €166 thousand, with net loss increasing to €41.0 million for the first nine months of 2024 compared to €26.7 million in the same period of 2023.
InflaRx (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, announced it will release its Q3 2024 financial results on November 8, 2024, before market open. The company will also participate in the Guggenheim Securities Inaugural Healthcare Innovation Conference from November 11-13, 2024, in Boston, featuring a fireside chat on November 11th at 11:00 am ET. InflaRx specializes in developing inhibitors of complement activation factor C5a and its receptor C5aR, with their lead candidate vilobelimab and oral small molecule inhibitor INF904.
InflaRx presented a post hoc analysis of the SHINE Phase 2b study of vilobelimab in hidradenitis suppurativa (HS) at the 2024 EADV Congress. The analysis focused on the 1200 mg dose, which showed significant improvements compared to placebo at 16 weeks:
- 45.2% reduction in draining tunnels
- 25.1% reduction in total lesion count
- 31.6% reduction in International Hidradenitis Suppurativa Score 4
These results suggest meaningful clinical benefits for vilobelimab in HS and support using a modified version of the HiSCR that measures drug activity against all three lesion types, emphasizing the reduction of draining tunnels. The company believes this analysis provides insights into vilobelimab's potential to address underlying inflammation in HS.
InflaRx N.V. (Nasdaq: IFRX) presented preclinical data for its novel oral C5aR inhibitor, INF904, at the 2024 European Meeting on Complement in Human Diseases. The findings demonstrate INF904's significant anti-inflammatory properties and strong pharmacokinetic profile. In a hamster neutropenia model, INF904 inhibited C5a-induced neutropenia by 96.5% compared to 51.1% for the same dose of avacopan. INF904 also showed a 2- to 5-fold higher exposure than avacopan across all tested animal species and is a much weaker inhibitor of CYP3A4/5 enzymes.
Results from in vitro and in vivo inflammatory disease models indicated that INF904 reduces neutrophil activation and shows significant anti-inflammatory effects. A first-in-human study demonstrated that INF904 is well-tolerated with no safety signals of concern in single doses up to 240 mg and multiple doses up to 90 mg twice daily for 14 days.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, has announced its participation in two investor conferences in September 2024. The company will attend the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11 in New York, offering an on-demand virtual presentation and one-on-one investor meetings. Additionally, InflaRx will participate in the 2024 Cantor Global Healthcare Conference from September 17-19, featuring a fireside chat on September 18th at 9:45 am ET and investor meetings.
InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenously delivered anti-C5a monoclonal antibody that has shown promising clinical activity in various indications. The company is also developing INF904, an oral small molecule inhibitor of the C5a receptor.
InflaRx (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, reported its Q2 2024 financial results and business update.
Key highlights include:
- R&D event on INF904's potential in inflammation & immunology.
- Phase 2a study for INF904 in CSU and HS expected by year-end 2024; Phase 2a data readout in summer 2025; Phase 2b trial initiation in 2025.
- Interim analysis for vilobelimab Phase 3 trial in PG expected in 2025.
- Vilobelimab selected for BARDA-sponsored ARDS trial.
- Cash and equivalents of €74.6 million, expected to fund operations into 2026.
Financials:
- Revenue: €42 thousand from GOHIBIC sales.
- Net loss: €23.5 million, compared to €19.3 million in the first half of 2023.
- R&D expenses: €17.3 million, down by €8.3 million year-over-year.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, has announced it will release its second quarter 2024 financial and operating results on August 8, 2024, before the market opens. No conference call is scheduled for this report.
InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenously delivered anti-C5a monoclonal antibody that has shown promising clinical activity in various indications. The company is also developing INF904, an oral small molecule inhibitor of the C5a receptor.
Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, will present preclinical data on INF904, their novel oral C5aR inhibitor, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) in Lübeck, Germany, from September 2-6, 2024. The company will showcase two poster presentations, participate in a C5a/C5aR-focused panel discussion, and speak at a satellite symposium.
INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has demonstrated anti-inflammatory effects in preclinical models. A first-in-human study showed that INF904 is well-tolerated and exhibits no safety concerns in single doses from 3 mg to 240 mg or multiple doses from 30 mg QD to 90 mg BID for 14 days. The drug achieved ≥90% blockade of C5a-induced neutrophil activation over the 14-day dosing period, supporting its potential as a best-in-class treatment.
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