US biopharma Paratek Pharmaceuticals (Nasdaq: PRTK) was up around 35% at $18.60 during pre-market trading on Tuesday as investors reacted to news on its lead candidate, omadacycline.
This once-daily oral and IV, broad spectrum investigational antibiotic, met all US Food and Drug Administration (FDA) primary and secondary endpoints and European Medicines Agency (EMA) co-primary endpoints in a global, pivotal Phase III study in community-acquired bacterial pneumonia (CABP).
The trial is a comparison of Paratek’s drug to moxifloxacin and represents the second positive Phase III registration study of omadacycline, which was also shown to be generally safe and well tolerated, consistent with prior studies.
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