Us2.ai receives FDA clearance for Us2.v2,transforming…

San Diego, CA, Mar. 19, 2018 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including deadly fungal pathogens, today announced that the US Food and Drug Administration (FDA) has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company's lead antifungal product candidate. The QIDP designation, a provision under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, was approved by Congress in 2012 to offer incentives to companies to bring to market new treatments for deadly infections. These incentives provide APX001 with eligibility for priority FDA review and fast-track status, and an additional five years of market exclusivity under the Hatch-Waxman Act. Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis. This new QIDP status expands the eligible population to include the treatment of cryptococcosis.