BioVersys Wins US FDA Fast Track Designation for Lead Clinical Asset BV100

MT Newswires · 5d ago
02:04 AM EDT, 09/02/2026 (MT Newswires) -- BioVersys (BIOV.SW) said Wednesday it received fast-track designation from the US Food and Drug Administration for BV100, its lead clinical asset. BV100 is a potential anti-infective agent for treating hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex. It is currently being evaluated in the phase 3 RIV-Target trial and the phase 2b RIV-Care study. The designation was granted under the qualified infectious disease product scheme.