BioVersys AG (BIOV) has received the go-ahead from the U.S. FDA to begin enrolling U.S. patients in its pivotal Phase 3 trial of BV100, a potential best-in-class treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by highly drug-resistant Acinetobacter infections.
The FDA's confirmation allows the global study to move forward as planned, marking a major regulatory milestone for the company.
Hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP) are serious infections that often affect critically ill patients. When caused by carbapenem-resistant Acinetobacter baumannii (CRAB) strains - one of the most difficult-to-treat pathogens- mortality rates can reach up to 50%. Treatment options are extremely limited, making new therapies urgently needed.
BV100 is an intravenous formulation of rifabutin designed to actively penetrate Acinetobacter bacteria through a newly identified uptake mechanism. The drug has been granted Qualified Infectious Disease Product (QIDP) status by the FDA, providing eligibility for priority review, Fast Track designation, and extended market exclusivity upon approval.
The global Phase 3 trial, known as RIV-TARGET, will evaluate BV100 plus low-dose polymyxin B against a comparator regimen in approximately 300 patients with suspected or confirmed carbapenem-resistant Acinetobacter infections. The primary endpoint will measure 28-day all-cause mortality, a critical benchmark in severe pneumonia studies. Secondary endpoints include clinical cure rates, ventilator-free days, and time spent in the ICU and hospital. An additional open-label cohort will enroll patients whose infections are resistant to colistin or polymyxin B, or who have failed prior therapy.
The Phase 3 design closely mirrors BioVersys' successful Phase 2 study, where BV100 combined with polymyxin B demonstrated a 50% relative reduction in 28-day mortality compared with best available therapy in patients with confirmed carbapenem-resistant Acinetobacter VABP. The company expects the Phase 3 readout by the end of 2027, with regulatory submissions planned for 2028 in the U.S., Europe, and China.
BioVersys will also launch a Phase 2b differentiation study, RIV-CARE, in the first half of 2026 to gather real-world evidence across multiple regions with high resistance rates. Interim data are anticipated by the end of 2026.
Marc Gitzinger, CEO of BioVersys, said that the FDA's decision represents an important step toward bringing a much-needed treatment to patients facing life-threatening infections. The company emphasized that interest from U.S. clinical sites is strong and that global trial activation is underway.
BIOV has traded between CHF 21.20 and CHF 36.60 over the past year. The stock closed Friday's trading session (March 13, 2026) at CHF 27.10, down 3.90%.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.