Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are serious hospital-treated infections associated with high rates of multi-drug resistant (MDR) bacteria, including carbapenem-resistant organisms (CROs) (e.g., carbapenemase-producing Enterobacteriaceae and MDR A. baumannii and P. aeruginosa), as well as significant morbidity and mortality. Although several therapies in late-stage clinical development are active against these CROs, developers have faced difficulty in conducting HABP/VABP trials as a result of changes in and misalignment between the FDA’s and EMA’s clinical trial guidelines for this indication. Nonetheless, significant opportunity remains for antibiotic products with efficacy against drug-resistant HABP/VABP, including HABP/VABP due to CROs. Such therapies are poised to command premium prices in the GNI market.