IFRX-Small-Talk WKN: A2H7A5 ISIN: NL0012661870 Kürzel: IFRX Forum: Aktien User: gustl2019

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Alter … endlich

65%

https://www.globenewswire.com/news-release/2023/04/04/2641171/0/en/InflaRx-Receives-FDA-Emergency-Use-Authorization-for-Gohibic-vilobelimab-for-Treatment-of-Critically-Ill-COVID-19-Patients.html

FDA Zulassung

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Gleich kommt Bobreben

Schalt mal Barolo frei 😂😂😂😂 gucken wie er so drauf is heute

🎊🍻🥳🥳🥳🥳🥳🎉🎉🎉🎉

Wie waren wir schon verzweifelt:-)

Scheiss die Wand an 😂

Leute o´zapt is

Grade gekommen

InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients • 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 FDA to discuss next steps towards a Biologics License Application submission for full approval • Encouraging pre-submission meetings held with EMA in Europe; InflaRx plans to apply for full approval to treat critically ill COVID-19 patients • Company to host a conference call tomorrow, April 5th at 8:30 am EDT/2:30 pm CEST Jena, Germany, April 04, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said: “We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug. Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S. as reported by the U.S. Centers for Disease Control and Prevention. Today’s announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available

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