Amplyx Pharma’s antifungal product candidate, APX001 receives fourth QIDP designation from US FDA

Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including, 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 US 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.