InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

Loading...
Loading...
  • InflaRx N.V. IFRX provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.
  • The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG.
  • PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.
  •  In addition, the company had a productive FDA end-of-phase II meeting to its plans for a Phase 3 development program in PG. 
  • The FDA indicated its support for a randomized, controlled Phase 3 study and offered to review the study protocol. 
  • Based on the agency's feedback and recommendations, InflaRx is now finalizing the design for a Phase 3 trial.
  • InflaRx requested a meeting with the FDA to obtain guidance for a potential emergency use authorization submission of vilobelimab in COVID-19 patients.
  • Related: InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients.
  • This has been scheduled as a Type B meeting for early Q3. In addition, the company is in ongoing dialogue with the EMA about the next steps in developing vilobelimab in mechanically ventilated severe COVID-19 patients.
  • Price Action: IFRX shares were down 6.91% at $1.42 during the market session on the last check Wednesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsPenny StocksHealth CareMoversTrading IdeasGeneralBriefsCOVID-19 Coronavirus
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...