Business
BioVersys Receives Green Light from US FDA for BV100 HABP/VABP Phase 3 Pivotal Trial Start
Ad hoc announcement pursuant to Art. 53 LR 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. BASEL, Switzerland, March 16, 2026
About this update from Bioversys Ag
[{"type":"image","alt":"BioVersys","displaySize":"","headline":null,"caption":"BioVersys","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":65,"url":"https://media.zenfs.com/en/globenewswire.com/c1af1ca0425507c351838a72eb663c47"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/_Zo6ExiGAEwq5bzAtMXIVw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTkxO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/c1af1ca0425507c351838a72eb663c47","width":300,"height":65}},"lazy":false},{"type":"text","content":"Ad hoc announcement pursuant to Art. 53 LR","length":42,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"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).","length":228,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":228,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"US FDA confirms that the BV100 global pivotal Phase 3 HABP/VABP trial may proceed, based on the initial IND submission. ","length":119,"tagName":"p"}]},{"val":[{"type":"text","content":"BV100 global pivotal Phase 3 is on track to read-out by the end of 2027.","length":72,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":191,"olType":false},{"type":"text","content":"BASEL, Switzerland, March 16, 2026 (GLOBE NEWSWIRE) -- 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).","length":702,"tagName":"p"},{"type":"text","content":"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 ...