FDA extends review of Progenics' Azedra

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) slipped $0.82 (10%) to $7.54 on Friday after it said FDA will extend its review of an NDA for Azedra iobenguane I 131, postponing its PDUFA date to July 30 from April 30. The therapy is under Priority Review to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma, which are types of neuroendocrine tumors (see BioCentury Extra, Dec. 29, 2017).

Progenics said FDA needed more time to review additional CMC data the company has submitted...