Shares of Heron Therapeutics, Inc. HRTX rose 9.22% on Dec 31 after the company announced that the FDA has accepted the new drug application (NDA) for experimental candidate, HTX-011, which was submitted to the agency on Oct 30, 2018. The FDA also granted the NDA a Priority Review designation.
Notably, the company’s shares gained 37.2% in 2018, while the industry declined 20.4%.
Priority Review designation is given to drugs, which upon approval would result in significant improvements in the safety or effectiveness of the treatment or prevention of serious medical conditions.
Meanwhile, the FDA had indicated that it is currently not planning to hold an advisory committee meeting to discuss this application and the agency has set a Prescription Drug User Fee Act goal date of Apr 30, 2019.
The candidate, which utilizes Heron's proprietary Biochronomer drug delivery technology, is a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. It is being evaluated for the management of postoperative pain. The candidate is designed to address both postoperative pain and inflammation in a single administration at the surgical site.
The NDA is supported by data from five phase II clinical trials and two phase III clinical trials that included more than 1,000 patients undergoing five different surgical procedures.
We remind investors that the FDA had earlier granted Breakthrough Therapy designation to HTX-011, based on the results of phase II studies and two completed phase III studies. These studies showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution, which is the standard of care. The candidate was also granted Fast Track designation by the FDA in the fourth quarter of 2017.
The results of various studies showed that HTX-011 was more effective in reducing pain than placebo or bupivacaine alone in five diverse surgical models — hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation.
A tentative approval will be a significant boost for the company. There is a great need for safe, effective and non-addictive options that can decrease opioid exposure, given the current epidemic of opioid abuse that has put companies like Endo International ENDP and Mallinckrodt MNK, among others, under the scanner.
Zacks Rank & Stock to Consider
Heron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Bristol-Myers Squibb Company BMY, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.03 to $4.14 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, the average being 11.99%.
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