Posted by Michael Wonder on 10 Sep 2019
FDA grants fast track status to Amplyx Pharmaceuticals for IV and oral formulations of fosmanogepix (APX001) for seven different indications
9 September 2019 - -- Amplyx Pharmaceuticals announced today that the U.S. FDA has granted fast track designations for both the intravenous (IV) and oral formulations of the company's lead antifungal candidate, fosmanogepix (APX001), for seven indications.
These indications include treatment of invasive candidiasis, treatment of invasive aspergillosis, treatment of scedosporiosis, treatment of fusariosis, treatment of mucormycosis, treatment of cryptococcosis and treatment of coccidioidomycosis.
Amplyx is investigating the safety and efficacy of fosmanogepix in its ongoing global Phase 2 clinical program.
