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Progenics Pharmaceuticals tumor therapy's FDA review extended by 3 months

Progenics Pharmaceuticals, Inc. said the U.S. Food and Drug Administration extended the review of its tumor therapy Azedra by three months to July 30.

The company had filed a new drug application in November 2017 for Azedra to treat malignant, recurrent or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors that arise from the cells of the autonomic nervous system.

The FDA had granted Progenics' request for priority review, with an expected action date of April 30.

The New York-based company said the extension is the result of the submission of additional chemistry, manufacturing and controls information, which required additional time for FDA review and is not related to the efficacy or safety data of Azedra.