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Progenics On Way To The FDA With Second Product Offering Azedra

 
• By Alexandra Shimmings

Progenics looks set to expand its product portfolio with a mid-year filing expected for its novel radiopharmaceutical product in ultra-rare neuroendocrine tumors following success in a pivotal study conducted under an SPA.

Progenics Pharmaceuticals Inc.'s registrational Phase IIb study of its novel radiotherapeutic Azedra (iobenguane I 131) Injection, has hit its primary endpoint, setting the stage for an FDA filing in the next quarter and opening up a new ultra-orphan market.

The open-label, multi-center study was conducted under a special protocol assessment (SPA) and evaluated Azedra in patients with malignant and/or recurrent pheochromocytoma or paraganglioma, two related and very rare neuroendocrine...

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