JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for... Read More

Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG) to enable interim analysis, with guidance for trial size adaptation or futility expected by the end of 2Q 2025 InflaRx pipeline highlighted at multiple medical congresses, including vilobelimab in COVID-19 and hidradenitis suppurativa (HS) and INF904 Phase 2a trial for INF904 expected to initiate by year-end 2024, with first... Read More

JENA, Germany, Oct. 31, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will report its third quarter 2024 financial and operating results on Friday, November 8, 2024, before the market opens. No conference call is planned. In addition, InflaRx will participate in the following... Read More

JENA, Germany, Sept. 25, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced the e-poster presentation of a post hoc analysis of the SHINE Phase 2b study of its first-in-class anti-C5a antibody, vilobelimab, in hidradenitis suppurativa (HS) at the 2024 European Academy of Dermatology and Venereology (EADV)... Read More

JENA, Germany, Sept. 03, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced the presentation of preclinical data for the company’s novel oral C5aR inhibitor, INF904, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) being held in Lübeck, Germany, September 2 – 6, 2024. Members of... Read More

JENA, Germany, Aug. 27, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will participate in two investor conferences in September 2024. Details are as follows: H.C. Wainwright 26th Annual Global Investment Conference September 9-11, 2024 in New York, NY InflaRx’s on-demand virtual... Read More

Hosted research and development (R&D) event focused on the differentiation of INF904 and its potential in addressing significant unmet needs in inflammation & immunology (I&I) Initiation of a Phase 2a study with INF904 in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected by year-end 2024 First Phase 2a data readout for INF904 expected in the summer of 2025, with Phase 2b trial initiation expected... Read More

JENA, Germany, Aug. 01, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will report its second quarter 2024 financial and operating results on August 8, 2024, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company... Read More

JENA, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced it will present preclinical data on the company’s novel oral C5aR inhibitor, INF904, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) being held in Lübeck, Germany, September 2 – 6, 2024. In addition to two... Read More

JENA, Germany, June 24, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and... Read More

Thought leaders in complement inhibition, chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) provide compelling new insights into the strong development rationales, potential differentiation and medical role of INF904 in initially targeted indications and inflammation & immunology (I&I) more broadly Additional details provided on INF904 Phase 2a trial design in moderate-to-severe CSU and HS, with study... Read More

JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego. InflaRx is presenting a poster at the thematic poster session at the ATS conference today from... Read More

Virtual R&D event to be held on June 5, 2024 from 12:00 to 2:00 PM EDT – highlighting company plans for INF904 and the opportunity, the role of C5aR in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) and C5a/C5aR signaling in human inflammatory diseases INF904 multiple ascending dose (MAD) pharmacokinetic (PK) and pharmacodynamic (PD) data supporting best-in-class potential announced, and plans to... Read More

JENA, Germany, April 30, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will report its first quarter 2024 financial and operating results on May 8, 2024, before the market opens. No conference call is planned for the first quarter 2024 results. InflaRx also announced it will host a virtual... Read More

JENA, Germany, April 24, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in the Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event to be held in New York City. InflaRx will participate in a panel titled, New Potential Dermatology Treatments for... Read More

InflaRx will focus development activities and resources initially on selected indications in immuno-dermatology, with registrational-phase vilobelimab and potentially best-in-class oral C5aR inhibitor INF904 INF904 development will be initially targeted at chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with initiation of a Phase IIa PK dose-ranging study expected by the end of 2024, with data... Read More

JENA, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will host a conference call this Thursday, March 21, 2024 at 8:00 am ET / 1:00 pm CET to discuss the Company’s anticipated development plans for INF904, InflaRx’s orally available C5aR inhibitor with best-in-class... Read More

JENA, Germany, Feb. 22, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced the appointment of Jan Medina, CFA, as Vice President and Head of Investor Relations of InflaRx. Mr. Medina brings over 25 years of extensive experience across the life sciences sector and capital markets, including in the areas... Read More

InflaRx to cover costs of GOHIBIC for patients who are treated in line with its Emergency Use Authorization (EUA) but do not survive. InflaRx is determined to support broader access to GOHIBIC for eligible patients. ANN ARBOR, Mich., Jan. 25, 2024 (GLOBE NEWSWIRE) -- InflaRx Pharmaceuticals Inc ., a subsidiary of InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting... Read More

MAD pharmacokinetic and pharmacodynamic data support best-in-class potential of INF904 over tested dose range of 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days: Achieved ≥90% blockade of C5a-induced neutrophil activation over 14-day dosing period Achieved favorable concentration-time profiles with target exposures of therapeutic potential Well tolerated with no safety signals of concern over entire dose... Read More

Multi-national, randomized, controlled adaptive Phase III study in ulcerative pyoderma gangrenosum (PG) initiated and first patient dosed in the U.S. PG is a rare and debilitating autoimmune skin disease characterized by painful ulcers that can rapidly progress JENA, Germany, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the... Read More

Single ascending dose (SAD) Phase I data confirm best-in-class potential of orally available C5aR inhibitor INF904; multiple ascending dose (MAD) part ongoing Six clinical sites initiated; first patients screened in Phase III trial of vilobelimab in pyoderma gangrenosum (PG) FDA regulatory pathway towards BLA in broader acute respiratory distress syndrome (ARDS) indication discussed in encouraging FDA Type C meeting MAA for... Read More

SAD data confirm best-in-class potential for INF904 as orally administered C5aR inhibitor: Safety and tolerability with no signals of concern over entire dose range Pharmacokinetics (PK): favorable dose-proportional systemic exposure with overall PK profile confirming pre-clinical data Desired blocking activity (>90%) of C5a-induced neutrophil activation at disease relevant C5a levels 24 hours post administration for doses... Read More

MAA for vilobelimab was submitted in July MAA has been validated by EMA and is now under review Regulatory submission based on pivotal data from PANAMO Phase III trial Company announces attendance at upcoming scientific and investor events JENA, Germany, Aug. 30, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced... Read More

Quarter highlighted by the Emergency Use Authorization (EUA) and commercial launch of Gohibic (vilobelimab) in the United States Oral C5aR inhibitor INF904 progressing in single ascending dose (SAD) and multiple ascending dose (MAD) Phase I trial Progress in clinical development of vilobelimab in other indications, including cutaneous squamous cell carcinoma (cSCC) and pyoderma gangrenosum (PG) Strong addition to management... Read More

Camilla Chong, M.D., joins the team with 25 years of experience in the global pharmaceutical industry in drug development Dr. Chong to lead clinical development of InflaRx’s portfolio of C5a/C5aR inhibitors JENA, Germany, June 28, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system,... Read More

Gohibic is now commercially available for hospitals in the U.S. Gohibic can be used under an Emergency Use Authorization (EUA) granted by the FDA for treatment of certain critically ill COVID-19 patients JENA, Germany, June 21, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the commercial launch of... Read More

Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patients Gohibic planned to be available to patients in the U.S. within the next few weeks Phase III study with vilobelimab in pyoderma gangrenosum (PG) underway; first patient expected to be enrolled mid-2023 Cash, cash equivalents and marketable securities approximately... Read More

JENA, Germany, April 18, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that, in connection with its previously announced completion of its underwritten public offering of 9,411,765 ordinary shares, the underwriters have fully exercised their option to purchase an... Read More

JENA, Germany, April 14, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has completed its underwritten public offering of 9,411,765 ordinary shares at a public offering price of $4.25 per ordinary share. The aggregate gross proceeds from the offering were... Read More

JENA, Germany, April 12, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the pricing of its underwritten public offering of 9,411,765 ordinary shares at an offering price of $4.25 per ordinary share. The offering is expected to close on April 14, 2023, subject to the... Read More

JENA, Germany, April 11, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has commenced an underwritten public offering of ordinary shares of the Company. The offering is subject to market conditions, and there can be no assurance as to whether or when the... Read More

Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients InflaRx continues the dialogue with... Read More

Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol submitted; first patient expected around mid-2023 Fast Track and Orphan Drug designations granted for treatment of pyoderma gangrenosum (PG) in the United States and Orphan Drug designation granted in Europe Encouraging results... Read More

Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG) Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 patients FDA review of application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill COVID-19 patients ongoing InflaRx’s management team to host investor... Read More

InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in China STS plans to request regulatory approval in China for its own anti-C5a-antibody BDB-001 for the treatment of COVID-19 based on InflaRx’s technology in-licensed by STS InflaRx will receive 10% royalties on net sales of BDB-001 for the treatment of COVID-19 in China STS to... Read More