Heron Therapeutics Inc (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced that it has resubmitted its New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA). Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by the FDA.
The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study in patients receiving HEC agents. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO guidelines for classification of emetogenic potential, is the only Phase 3 CINV study to-date to use the currently recommended, standard-of-care, three-drug regimen for CINV prophylaxis in a HEC population as the comparator: a 5-HT3 receptor antagonist, fosaprepitant and dexamethasone.
The MAGIC study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Significant benefit was also observed in the reduction in episodes of nausea, which has the greatest impact on patient quality of life. Data from a previous Phase 3 study of more than 1,300 patients, which was previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.
“The rapid resubmission of the NDA for SUSTOL, the first and only 5-HT3 receptor antagonist with extended-release technology and 5-day CINV prevention in both MEC and HEC, is a major milestone for Heron Therapeutics,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We look forward to working closely with the FDA during the SUSTOL NDA review period, as we believe SUSTOL has the potential to improve the lives of patients suffering from CINV by significantly reducing both nausea and vomiting associated with MEC or HEC regimens.” (Original Source)
Shares of Heron Therapeutics Inc closed last Friday at $35.89. HRTX has a 1-year high of $35.98 and a 1-year low of $6.51. The stock’s 50-day moving average is $30.12 and its 200-day moving average is $16.57.
On the ratings front, Heron Therapeutics has been the subject of a number of recent research reports. In a report issued on June 26, Cowen analyst Boris Peaker initiated coverage with a Buy rating on HRTX and a price target of $40, which represents a potential upside of 11.5% from where the stock is currently trading. Separately, on June 19, Leerink Swann’s Jason Gerberry reiterated a Buy rating on the stock and has a price target of $38.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Jason Gerberry have a total average return of 37.3% and 22.6% respectively. Peaker has a success rate of 58.5% and is ranked #38 out of 3712 analysts, while Gerberry has a success rate of 88.1% and is ranked #196.
Heron Therapeutics Incis a biotechnology company, developing products to address unmet medical needs. ItsproprietaryBiochronomer polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals.