Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced details of its planned Phase 3 clinical trial for 1404, a developmental stage small molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA). Following recent End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), the design and key elements of a Phase 3 clinical trial for 1404 have been finalized.
“The successful completion of our End-of-Phase 2 discussions with the FDA represents a milestone in our 1404 program,” stated Mark Baker, CEO of Progenics. “Our Phase 3 study builds on our positive Phase 2 data, which established the broad potential of 1404 to detect local and metastatic prostate cancer in a wide range of patients, from low to high grade disease. Our Phase 3 program is designed to support commercialization in our initial target market for the 1404 imaging agent in the U.S. — patients with early disease who may be candidates for active surveillance.”
The Phase 3 clinical trial is expected to enroll approximately 450 patients with biopsy-proven low-grade prostate cancer who are candidates for active surveillance but have planned to undergo radical prostatectomy (RP). The multicenter, multi-reader, open-label study will evaluate the specificity and sensitivity of 1404 to identify clinically significant prostate cancer. Histopathology of the tumor tissue will be used as the truth standard. An interim analysis will be performed after approximately one-third of the subjects have been treated and will include an analysis for futility and also evaluate the need for a sample size re-estimation.
Progenics expects the Phase 3 trial to commence by the end of this year. (Original Source)
Shares of Progenics closed yesterday at $7.07. PGNX has a 1-year high of $9.27 and a 1-year low of $4.02. The stock’s 50-day moving average is $6.37 and its 200-day moving average is $6.25.
On the ratings front, Progenics has been the subject of a number of recent research reports. In a report issued on May 26, BTIG analyst Hartaj Singh initiated coverage with a Buy rating on PGNX and a price target of $12, which represents a potential upside of 69.7% from where the stock is currently trading. Separately, on May 6, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Hartaj Singh and Jonathan Aschoff have a total average return of 18.9% and 11.4% respectively. Singh has a success rate of 69.2% and is ranked #906 out of 3691 analysts, while Aschoff has a success rate of 55.3% and is ranked #196.
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.