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June 21, 2023 07:00 ET | Source: InflaRx N.V.

InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients

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...
May 11, 2023 07:30 ET | Source: InflaRx N.V.

InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update

Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patientsGohibic planned to be available to...
April 04, 2023 14:55 ET | Source: InflaRx N.V.

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 responseFDA granted EUA based on Phase III...
March 22, 2023 07:30 ET | Source: InflaRx N.V.

InflaRx Reports Full Year 2022 Financial and Operating Results

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...
January 05, 2023 07:30 ET | Source: InflaRx N.V.

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

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...
December 21, 2022 07:30 ET | Source: InflaRx N.V.

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

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...
November 09, 2022 07:30 ET | Source: InflaRx N.V.

InflaRx Reports Third Quarter 2022 Financial & Operating Results

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....
September 29, 2022 07:30 ET | Source: InflaRx N.V.

InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients

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...
September 09, 2022 07:30 ET | Source: InflaRx N.V.

InflaRx to Present at Upcoming Scientific and Investor Conferences

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...
September 08, 2022 07:30 ET | Source: InflaRx N.V.

InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine

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...