Company Update (NASDAQ:HRTX): Heron Therapeutics Inc Notified by FDA That It Will Not Take Action on SUSTOL® New Drug Application by the PDUFA Date
Heron Therapeutics Inc (NASDAQ:HRTX) announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016.
SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer® drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection. (Original Source)
Shares of Heron Therapeutics closed yesterday at $23.22. HRTX has a 1-year high of $42.25 and a 1-year low of $7.09. The stock’s 50-day moving average is $26.90 and its 200-day moving average is $29.68.
On the ratings front, Heron has been the subject of a number of recent research reports. In a report issued on January 6, Noble Financial analyst Rahul Jasuja reiterated a Buy rating on HRTX, with a price target of $51, which implies an upside of 119.6% from current levels. Separately, on December 10, Lake Street Capital’s Carl Byrnes initiated coverage with a Buy rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Rahul Jasuja and Carl Byrnes have a total average return of -15.0% and -26.2% respectively. Jasuja has a success rate of 6.7% and is ranked #3257 out of 3607 analysts, while Byrnes has a success rate of 0.0% and is ranked #2835.
Heron Therapeutics Inc is a biotechnology company, developing products to address unmet medical needs. Its proprietary Biochronomer polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals.