A step-change year for development activity

BioVersys’s FY25 results underscore a transition into a catalyst-rich, late-stage development phase. Following FDA clearance, first patient dosing in the registrational Phase III trial for lead asset BV100 is set to commence in April 2026. The Phase IIb real-world evidence study will run in parallel, supported by the Wellcome Trust-funded ADVANCE-ID network, with both studies reading out in H227. Pipeline momentum extends to alpibectir (partnered with GSK), where a GSK-led Phase IIb/c pulmonary TB study initiated in March 2026, while a Phase IIb TB meningitis trial (BioVersys-led) is planned for Q226. Dual readouts by end-2027 are expected to shape the Phase III strategy. Earlier-stage assets BV500 (Shionogi collaboration) and BV200 cont...