According to the FDA, the agency will extend its review of the New Drug Application (NDA) for Azedra (iobenguane I 131) by three months. So now the Prescription Drug User Fee Act (PDUFA) target action date is moved back to July 30, 2018.
For some quick background: Azedra is a later-stage drug candidate being developed for the treatment of malignant pheochromocytoma and paraganglioma. Pheochromocytomas are rare tumors that arise from cells of the sympathetic nervous system. Such tumors are usually found within one or both adrenal glands (85%) but may arise in other areas of sympathetic nerve cells and are then referred to as paragangliomas.
The extension is the result of the submission of additional Chemistry, Manufacturing, and Controls (CMC) information by Progenics, which required additional time for FDA review. The standard three-month extension is not related to the efficacy or safety data of Azedra.
Mark Baker, chief executive officer of Progenics, commented:
We remain confident in our NDA submission and are committed to bringing Azedra forward as an option for patients with malignant pheo and para. We look forward to continuing our dialogue with the Agency as we prepare for a potential approval of Azedra.
Excluding Friday’s move, Progenics has underperformed the markets over the past 52 weeks, with its stock down about 26%. In 2018 alone, however, the stock is up 40%.
Shares of Progenics traded down more than 9% early Friday at $7.56, with a consensus analyst price target of $13.75 and a 52-week trading range of $4.60 to $11.48. Following the announcement, the stock had down about 17% in premarket trading.