Progenics Pharmaceuticals, Inc. PGNX announced that it has completed patient enrolment in a pivotal phase IIb study on Azedra for the treatment of patients with malignant or recurrent pheochromocytoma and paraganglioma. The study is being conducted under the Special Protocol Assessment (SPA) agreement with the FDA.
Top-line data from the study is expected in the second half of 2016.
Azedra has an Orphan drug status and Fast Track designation in the U.S. In Jul 2015, the FDA granted a Breakthrough Therapy designation to Azedra for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma, and paraganglioma.
Meanwhile, the company continues to progress with its pipeline. Progenics plans to initiate a phase III study on 1404, a molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA), in patients with biopsy confirmed low-grade prostate cancer, who are eligible for active surveillance, but decided to have a radical prostatectomy before the year end.
Another PSMA-targeted molecule in the company’s pipeline is PyL, which it acquired through a licensing agreement with Johns Hopkins University in Aug 2015.
We remind investors that in Sep 2015, the company announced that the FDA had accepted its New Drug Application for Relistor for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. A response from the FDA is expected in Apr 19, 2016.
Progenics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT, each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment