The US Food and Drug Administration (FDA) granted a Fast Track designation to InflaRx’s (NASDAQ:IFRX) lead candidate Vilobelimab for the treatment of ulcerative Pyoderma Gangrenosum (PG).
The FDA grant was supported by the positive data readout in pyoderma gangrenosum (PG) from its Phase 2a open-label dose-escalation study.
Prof. Niels C. Riedemann, CEO and Founder, said, “The Fast Track designation will further facilitate our interactions with the FDA related to our development in PG and will also allow for faster review and approval upon successful completion of a Phase III development program.”
Previously, Vilobelimab was granted orphan drug designation for the treatment of PG by both the FDA in the United States and the European Medicines Agency (EMA) in Europe.
The company indicated positive End-of-Phase II meeting with the Division of Dermatology with the FDA related to its Phase III development plans in PG.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Action: InflaRx shares are trading about 10 percent high at $1.56 on Wednesday pre-market session at the time of publication.
