The stock of Progenics Pharmaceuticals, Inc (NASDAQ:PGNX) closed at $6.15 gaining 3.36% in yesterday’s trading session. Progenics Pharmaceuticals has disclosed that the U.S. Food and Drug Administration (FDA) is willing to move ahead and review its latest Drug Application (NDA).It is a product that will play a significant role towards the treatment of some rare neuroendocrine tumors.
A person familiar with the matter said, “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). 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.”
The Chief Executive Officer of Progenics, Mark Baker said that as a company they were pleased with FDA’s move. He outlined that they were willing to give the body maximum cooperation as it embarked on the review process.
He went further to outline that they were setting up the groundwork in line with the company’s commercial plan. If approved, the company will proceed to launch the product as soon as possible.
Analysts familiar with the most recently developments have given their personal opinions outlining that it was an encouraging thing that the trial was able to meet the primary endpoint.
Baker proceeded to outline that they were happy about the much they had accomplished so far. He disclosed that coming up with the product hadn’t been easy since it was a matter that consumed much in terms of efforts and resources. They had come across numerous challenges along the way but were able to maneuver and eventually proceed. He said that challenges were part and parcel of business asserting that determination was what helped them get by.
Technological advancements are sweeping across the world with impact changing the way businesses are run as well as helping boost the outcomes. Progenics Pharmaceuticals over the years been keen to spot the various technological advancements that come up and has been exploiting them towards manufacturing leading products to patients around the globe.