BioVersys Receives Green Light from US FDA for BV100 HABP/VABP Phase 3 Pivotal Trial Start

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. March 16, 2026, 7am CET

• 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 (CRAB).
• US FDA confirms that the BV100 global pivotal Phase 3 HABP/VABP trial may proceed, based on the initial IND submission.
• BV100 global pivotal Phase 3 is on track to read-out by the end of 2027.

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 US Food and Drug Administration (US FDA) has confirmed that the global Phase 3 pivotal trial to recruit US patients into the RIV-TARGET clinical trial (NCT07326540) can proceed. The Phase 3 trial will recruit patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex (CRABC).

CRABC is a highly-drug resistant Gram-negative pathogen that is recognized as a critical priority by global health authorities. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex.  BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity.

Dr. Glenn E Dale, Chief Development Officer: “This is a significant step towards our goal of completing the BV100 global Phase 3 trial by the end of 2027. HABP and VABP infections remain a leading cause of infectious disease hospital mortality and represent a substantial burden on healthcare systems. Our teams have already gathered interest from US-based clinical sites to participate in the trial, and this successful IND application will allow us to activate the clinical sites prior to enrolling US patients in the coming months.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “We are excited about this regulatory development. Enrolling US patients into the trial is an important contribution towards the global nature of the study. This follows closely behind our announcement in December 2025 that we had initiated the BV100 global Phase 3 trial. I am incredibly proud of our team’s multi-pronged efforts in ensuring that this trial can proceed simultaneously in all the key regions of the world. We will bring this much-needed treatment option to patients in dire need.”

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