Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced that it intends to push off its NDA submission on Azedra, a treatment for malignant pheochromocytoma and paraganglioma, by another quarter, as it aims to gain FDA pre-approval inspection for its contract manufacture site. Clearly, the company believes the manufacturing and controls (CMC) requirement is needed to support a successful NDA submission, while all other requirements are already fulfilled.
While suggesting that the news may at least temporarily adversely affect company shares, analyst Mara Goldstein of Cantor does not believe that there is any reason to sound the alarm. The analyst stresses that “the delay is not driven by an issue with the drug product, but is related to documentation and training associated with SOPs for the production of the drug.” Moreover, opines Goldstein, “The delay in filing is modest and still suggests that commercial revenues are likely in 2018.”
Goldstein further cites to the company’s use of an outside consultancy and data presented to the 5th International Symposium on Pheochromocytoma and Paraganglioma, as further evidence to her assertion regarding the delayed NDA. The analyst notes, “The company is working with an outside consultant to improve SOPs and train staff, which does not seem like an insurmountable issue to us […] PGNX also presented data at the 5th International Symposium on Pheochromocytoma and Paraganglioma demonstrating an improved response over time, with 6% of patients achieving PR at three months and over 23% at 12 months. The data also confirm the benefit of two doses vs. one, with 48.73 months and 17.4 months median survival time, respectively. Top-line results of the study were disclosed earlier this year and provide the basis for the NDA filing.”
As such, Goldstein maintains an Overweight rating on PGNX with a $15.00 rating representing a 122% rise over current trading levels. (To watch Goldstein’s track record, click here)
TipRanks analytics exhibit PGNX as a Strong Buy. Out of 3 analysts polled by TipRanks in the last 3 months, all 3 are bullish on Progenics Pharmaceuticals stock. With a potential upside of 103%, the stock’s consensus target price stands at $13.67.