Eagle Pharma: FDA Grants QIDP And Fast-Track Designation For CAL02

(RTTNews) - Eagle Pharmaceuticals, Inc. (EGRX) announced the FDA has granted Qualified Infectious Disease Product Designation and Fast Track Designation for CAL02, a non-biological bacterial virulence neutralizer, anti-infective agent being developed to treat severe community-acquired bacterial pneumonia as an add-on therapy to standard of care.

A phase 2 randomized, double-blind, placebo-controlled study is underway, designed to assess the efficacy and safety of CAL02 administered intravenously in addition to standard of care in patients with severe community-acquired bacterial pneumonia. The study plans to enroll approximately 276 patients.

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