Shares of Heron Therapeutics (HRTX) are on the rise after the Food and Drug Administration accepted the new drug application for the company’s HTX-011 for the management of postoperative pain, and has granted it a Priority Review designation.
PRIORITY REVIEW GRANTED: Heron Therapeutics announced this morning that the FDA has accepted the new drug application for the company’s investigational agent, HTX-011, and has granted it a Priority Review designation. HTX-011 is a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. The NDA for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures. The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019. Priority Review designation is for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions. The overall safety profile of HTX-011, administered locally into the surgical site without a needle, was similar to that of the well-established safety profile of bupivacaine solution, without evidence of meloxicam-related toxicities.
WHAT’S NOTABLE: Last month, Leerink analyst Ami Fadia told investors that she believes the near-term trajectory for Pacira Pharmaceutical’s (PCRX) Exparel looks promising after the company reported that it grew 23% year-over-year in the third quarter. However, the analyst argued that Exparel’s growth could be pressured in later years due to competition from Heron Therapeutics' HTX-011.
PRICE ACTION: In morning trading, shares of Heron have gained almost 7% to $25.33, while Pacira’s stock has slipped about 2% to $41.74.
Heron Therapeutics
+1.98 (+8.35%)
Pacira
-0.68 (-1.60%)