PRTK - Paratek Pharmaceuticals stock soars postmarket on fast track designation for Nuzyra

Paratek Pharmaceuticals (NASDAQ:PRTK) stock jumped 14% postmarket Tuesday after the U.S. FDA granted fast track designation for oral and IV formulations of Nuzyra. The broad-spectrum antibiotic is used to treat pulmonary nontuberculous mycobacterial (NTM) disease caused by both mycobacterium avium complex and mycobacterium abscessus. The FDA granted Nuzyra orphan drug designation for these infections in Aug. Phase 2b study of Nuzyra in mycobacterium abscessus pulmonary infections is ongoing. The study will enroll ~75 patients who are not receiving other antibiotic treatments for their NTM pulmonary disease. The primary endpoints are improvement in symptoms, and safety and tolerability after 12 weeks of treatment. PRTK expects the study will take ~2 years to complete as very few patients have with this rare disease. Nonclinical studies of Nuzyra in mycobacterium avium complex have begun.

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Paratek Pharmaceuticals stock soars postmarket on fast track designation for Nuzyra