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ARTICLE | Clinical News

Progenics' Azedra headed for NDA

March 30, 2017 11:42 PM UTC

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said radiotherapeutic Azedra iobenguane I 131 met the primary endpoint in a registrational Phase IIb study to treat rare types of neuroendocrine tumors. Among 68 evaluable patients, Azedra led to a 50% or greater reduction of all antihypertensive medication for at least 6 months in 17 patients. The company said a minimum of 12 patients were needed to meet the endpoint.

Progenics plans to submit an NDA to FDA mid-2017. The radiolabeled norepinephrine analog has breakthrough therapy, Orphan Drug and Fast Track designations from FDA...

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