Nabriva goes 2 for 2 in Phase III antibiotic program, scoring on a key catalyst -- but shares plunge on safety worries
Nabriva Therapeutics $NBRV has scored a second, pivotal Phase III win for its antibiotic lefamulin in community acquired bacterial pneumonia — setting up a pitch to the FDA later this year and quite likely clearing a path to its first commercial launch.
Their antibiotic achieved non-inferiority compared to moxifloxacin for early clinical response (ECR) — 72 to 120 hours following initiation of therapy in the intent to treat patient population. In this trial, ECR rates were 90.8% for lefamulin and 90.8% for moxifloxacin. The trial also achieved European goals outlined for an approval.
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