InflaRx N.V. - IFRX STOCK NEWS

InflaRx (NASDAQ: IFRX) has received European Commission marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab), the first approved treatment in the European Union for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). The approval applies to adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without ECMO.

The authorization is supported by Phase 3 PANAMO trial results, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. The approval covers all 27 EU member states plus Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnering options in the EU.

In the US, GOHIBIC has received Emergency Use Authorization from the FDA for COVID-19 treatment in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, has announced its participation in multiple events during the week of January 13, 2025, in San Francisco. The company will attend the LifeSci Partners Corporate Access Event for one-on-one meetings on January 14-15, and participate in a workshop at Biotech Showcase 2025 on January 15 titled 'The Need for Novel Responses to Disease Threat(s) in a Fast-Changing World.'

InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenous anti-C5a monoclonal antibody. The company is also developing INF904, an oral C5a receptor inhibitor. Founded in 2007, InflaRx maintains offices in Jena and Munich, Germany, and Ann Arbor, MI, USA.

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.