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InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients
05 janv. 2023 07h30 HE | InflaRx N.V.
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...
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InflaRx Announces Amendment of Co-Development Agreement and Additional Equity Investment by Staidson in Connection with Regulatory Filing in China for Anti-C5a-Antibody for Treatment of COVID-19
21 déc. 2022 07h30 HE | InflaRx N.V.
InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in ChinaSTS plans to request regulatory approval in...
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InflaRx Reports Third Quarter 2022 Financial & Operating Results
09 nov. 2022 07h30 HE | InflaRx N.V.
Vilobelimab earns Orphan Drug and Fast Track designation for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients - Emergency Use Authorization (EUA) submitted to U.S....
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InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
29 sept. 2022 07h30 HE | InflaRx N.V.
Company also earns FDA Fast Track designation for vilobelimab to treat critically ill COVID-19 patientsEUA submission based on Phase III results in critically ill COVID-19 patients, recently published...
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InflaRx to Present at Upcoming Scientific and Investor Conferences
09 sept. 2022 07h30 HE | InflaRx N.V.
JENA, Germany, Sept. 09, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement...
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InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine
08 sept. 2022 07h30 HE | InflaRx N.V.
The Lancet Respiratory Medicine, a peer-reviewed journal, published the results of the PANAMO trial, one of the largest, global, 1:1 randomized, placebo-controlled Phase III studies conducted in...
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InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
06 juil. 2022 07h30 HE | InflaRx N.V.
US Food and Drug Administration awards Fast Track designation for the treatment of ulcerative pyoderma gangrenosumFast track follows recently reported orphan drug designation by both US FDA and EMA ...
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InflaRx to Present at the H.C. Wainwright Global Investment Conference
17 mai 2022 07h30 HE | InflaRx N.V.
JENA, Germany, May 17, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system,...
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InflaRx Reports First Quarter 2022 Financial and Operating Results and Provides Strategic Update
12 mai 2022 07h30 HE | InflaRx N.V.
Quarter highlighted by progress with vilobelimab in several indications: Encouraging Phase III topline results reported in patients with severe COVID-19; discussions with regulatory authorities...
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InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients
31 mars 2022 07h30 HE | InflaRx N.V.
Vilobelimab treatment results in relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (p-value=0.094), but did not show statistical significance on the pre-specified primary...