Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) saw its shares make a solid gain to close out the year after the U.S. Food and Drug Administration (FDA) accepted for review the firm’s New Drug Application (NDA) for Azedra.
Azedra works to treat patients with malignant, recurrent or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.
Previously, 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 (SPA) 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.
It also demonstrated 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 also was shown to be safe and generally well tolerated.
Mark Baker, CEO of Progenics, commented:
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. 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. At the same time, we will continue to lay the groundwork for our commercial plan and prepare to launch quickly following a potential approval.
Shares of Progenics were last seen up over 15% at $6.76, with a consensus analyst price target of $13.75 and a 52-week range of $4.60 to $11.72.