InflaRx Surges 83% Following FDA Emergency Use Authorization of COVID Drug

Clinical stage biopharmaceutical company, InflaRx N.V. (Nasdaq: IFRX), has been granted emergency-use authorization by the FDA for its monoclonal antibody, Gohibic (vilobelimab).

Under the authorization, Gohibic can be used in the treatment of hospitalized COVID 19 patients when initiated within 48 hours of receiving artificial life support.

The company’s shares soared 83% following the news.

 Highlights

 The FDA’s decision was supported by data from InflaRx’s randomized, double-blind placebo-controlled Phase III PANAMO trial in invasively mechanically ventilated COVID-19 patients in intensive care units.

The data, published in The Lancet Respiratory Medicine, showed that treatment with Gohibic improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.

Gohibic is not approved by the FDA, but InflaRx continues discussions with FDA related to submission of a Biologics License Application for full approval of Gohibic in this COVID-19 indication.

InflaRx has a supply of Gohibic available and is increasing production to roll out supply in the U.S. as soon as possible.

 About InflaRx

InflaRx is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. The company has offices and subsidiaries in Jena and Munich, Germany, and Ann Arbor, MI, USA.

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InflaRx Surges 83% Following FDA Emergency Use Authorization of COVID Drug

Sarah Davis