Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative ways to target and treat cancer, announced today that the U.S. Food and Drug Administration (FDA) has designated Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra is currently being evaluated in a pivotal Phase 2b trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.
The Breakthrough Therapy designation pathway was created by the FDA to expedite the development and review for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
“This Breakthrough Therapy designation for Azedra reflects the urgent need for new options for patients suffering from pheochromocytoma and paraganglioma,” stated Mark Baker, CEO of Progenics. “Azedra has the potential to be the first approved therapy for patients with these rare and devastating tumors, and this designation will allow for a close collaboration between Progenics and the FDA as we complete our ongoing pivotal Phase 2b trial and, assuming a positive trial outcome, advance Azedra through the regulatory review process.” (Original Source)
Following the news, Progenics shares jumped 20.35% to $11.00 in pre-market trading. PGNX has a 1-year high of $9.75 and a 1-year low of $4.26. The stock’s 50-day moving average is $7.45 and its 200-day moving average is $6.37.
On the ratings front, Progenics has been the subject of a number of recent research reports. In a report issued on July 23, Brean Murray Carret analyst Jonathan Aschoff maintained a Buy rating on PGNX, with a price target of $11, which implies an upside of 20.5% from current levels. Separately, on May 26, BTIG’s Hartaj Singh initiated coverage with a Buy rating on the stock and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Hartaj Singh have a total average return of 12.1% and 15.5% respectively. Aschoff has a success rate of 54.7% and is ranked #173 out of 3717 analysts, while Singh has a success rate of 69.2% and is ranked #1026.
Progenics Pharmaceuticals Inc is engaged in the development of medicines for oncology. The Company develops products for the treatment of prostate cancer, opioid-induced constipation, or OIC, as well as OIC for non-cancer pain.