FDA accepts Azedra NDA for two rare neuroendocrine tumors

2 January 2018

The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for Azedra (iobenguane I 131) in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.

The FDA granted Progenics Pharmaceuticals’ (Nasdaq: PGNX) request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). The news, announced on December 29, sent the company’s shares up 18.6% to $6.94, though they levelled off by close of trading.

Azedra became part of Progenic’s pipeline after the company acquired Molecular Insights in January 2013.

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