Progenics announces FDA acceptance of NDA for AZEDRA
Progenics Pharmaceuticals (PGNX) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for AZEDRA in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.
Pheochromocytoma and paraganglioma are rare tumors that form from neuroendocrine cells. Neuroendocrine cells release hormones into the blood when they receive a signal from the nervous system. Neuroendocrine cells are found all through the body.
Paragangliomas usually form near the carotid artery and along nerve pathways in the head, neck, and spine. Pheochromocytomas form in the adrenal medulla (the center of the adrenal gland found on top of each kidney).
Certain inherited disorders increase the risk of pheochromocytoma or paraganglioma. These include multiple endocrine neoplasia 2 syndrome, types A and B , von Hippel-Lindau syndrome, and neurofibromatosis type 1.
Pheochromocytomas and paragangliomas may be benign or malignant.
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).
The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment with the FDA.
The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria In Solid Tumors.
AZEDRA was also shown to be safe and generally well tolerated.
PGNX closed at $5.85. It last traded at $7.20 in pre-market trading.
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