Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA® (iobenguane I 131) in Pheochromocytoma and Paraganglioma
PROGENICS PHARMACEUTICALS (PGNX)
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Source: GlobeNewswire
NEW YORK, Dec. 29, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for AZEDRA® in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). “With no FDA-approved therapies for these rare tumors, AZEDRA has the potential to address the high unmet need of patients with malignant pheochromocytoma and paraganglioma,” said Mark Baker, Chief Executive Officer of Progenics. “We are pleased that the FDA has accepted our NDA with Priority Review, and look forward to working with the Agency during the review process.
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