Progenics officially got a thumbs up from the FDA on its cancer radiation therapy Azedra, sending the New York company’s stock climbing Monday afternoon. The drug was approved to treat rare and extremely lethal adrenal gland cancers for which there was no approved treatments. Until now.
Specifically, Azedra will treat pheocromocytoma and paraganglioma, neuroendocrine tumors that form from the same type of tissue. The five-year survival rate of unresectable cases can be as low as 12%. This new drug is a radiotherapy that goes after these tumors with a high, specifically targeted dose. The FDA gave it an orphan drug designation, fast track status, and breakthrough therapy designation.
The drug’s original PDUFA date got pushed back, though, on a three month delay due to some missing info on “chemistry, manufacturing, and controls,” the company said at the time. But the CMC matter seems to be resolved. Investors are pleased with the news, with Progenics’ stock $PGNX climbing nearly 12% since word of the approval broke this afternoon.
Azedra is a new version of the radiopharmaceutical iobenguane I-131. It’s made using a system known as UltraTrace, which results in less non-radioactive iobenguane during enrichment leading to greater delivery of radiation to the tumor. The UltraTrace technology was developed by Molecular Insight Pharmaceuticals, which was acquired by Progenics in early 2013.
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