BioVersys granted Fast-Track Designation from US FDA for BV100

Basel, Switzerland. September 2, 2026, 7am CEST

•    Fast-Track Designation supports the urgent need for novel and innovative antimicrobials for the treatment of serious infections caused by gram-negative bacteria.
•    BV100 is a potential best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC).

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BV100 under the Qualified Infectious Disease Product (QIDP) designation for the Company’s lead clinical asset, currently undergoing a Phase 3 study. 

The Fast Track designation is granted to BV100 for the treatment of ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP) caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). With the Fast Track designation, BioVersys can Benefit from more frequent interactions with the FDA, increased communication on clinical trial design and data requirements, and eligibility for rolling review.

BV100 is a novel intravenous formulation of the antibiotic rifabutin developed to Target severe CRABC infections. BV100 possesses a novel mode of Action via uptake via the siderophore pathway in Acinetobacter, providing a much-needed novel non-β-lactam therapy for this infection.

Dr. Marc Gitzinger, CEO of BioVersys, said: “We are pleased that the US FDA has granted Fast Track designation to BV100, our lead clinical asset. This designation underscores the significant unmet medical need for new treatment options for patients suffering from serious infections caused by multidrug-resistant Acinetobacter baumannii and supports our efforts to bring BV100 to patients as efficiently as possible." 

BV100 is currently studied in two clinical trials: the pivotal Phase 3 global registrational trial, RIV-TARGET and the open-label Phase 2b differentiation trial, RIV-CARE in collaboration with ADVANCE-ID. These studies follow the successful Phase 2 study that showed BV100 had an overall 50% reduction in mortality compared with best available therapy. In 2019, BV100 received the Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA. 

CRABC is a major cause of healthcare-associated infections and one of the most challenging multidrug-resistant pathogens to treat, with mortality rates reaching 50% globally. It is a WHO priority-1 critical pathogen.