SAN DIEGO - Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology firm, announced today that the U.S. Food and Drug Administration (FDA) has approved its Prior Approval Supplement Application for a new vial access needle (VAN) designed for use with ZYNRELEF, an extended-release solution for postoperative pain. The VAN is set to launch in the fourth quarter of 2024.
The FDA's approval marks a significant step for Heron, as the VAN is expected to simplify aseptic preparation and substantially reduce the withdrawal time of ZYNRELEF to between 20 and 45 seconds. The new "container-like" design of the VAN aims to enhance the safety and ease of use of ZYNRELEF, potentially increasing its adoption and improving the preparation process for healthcare providers.
Bill Forbes, PharmD, Executive Vice President and Chief Development Officer at Heron, commented on the approval, emphasizing the importance of reducing patients' pain during the first three days after surgery and expressing optimism about the VAN's potential to increase ZYNRELEF adoption and positively impact patient recovery.
The company's CEO, Craig Collard, highlighted the VAN approval as one of several milestones achieved in 2024, including ZYNRELEF's January label expansion and its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief (NOPAIN Act). Collard also mentioned the ongoing integration with CrossLink Life Sciences, LLC, as part of the company's progress.
ZYNRELEF, which contains a combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug meloxicam, was first approved by the FDA in May 2021 for use in certain surgical procedures. It has since expanded its indication to include additional types of surgeries. The product is noted for its ability to significantly reduce pain and decrease the need for opioids post-surgery.
This news is based on a press release statement from Heron Therapeutics, Inc. The company, dedicated to developing therapeutic innovations, is optimistic about the transformative impact the VAN will have on managing postoperative pain across various surgical procedures.
In other recent news, Heron Therapeutics reported significant developments in its Q2 2024 earnings call, noting a 15% increase in revenues and a substantial improvement in gross margins from 40% to 73%. The company's oncology products, CINVANTI and SUSTOL, played a significant role in this growth. Operating expenses saw a reduction by over $36 million compared to the same period last year.
Heron Therapeutics also announced the appointment of Brett Fleshman as its new Chief Business Officer. With a wealth of experience in the pharmaceutical and biotechnology sectors, Fleshman is expected to drive Heron's growth, focusing on inorganic revenue growth and investor relations. He previously held significant roles in corporate and business development, commercial strategy, and marketing.
The company is preparing for the launch of the Vial Access Needle (VAN), which is expected to contribute to future revenues. A decision on the ongoing CINVANTI patent infringement lawsuit is anticipated in Q4 of 2024. Furthermore, Heron Therapeutics plans to pursue more mergers and acquisitions as part of its strategic focus on growth. These are some of the recent developments at Heron Therapeutics.
InvestingPro Insights
In light of Heron Therapeutics' recent FDA approval for its new vial access needle (VAN), investors and industry observers are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, Heron Therapeutics boasts a market capitalization of $300.3 million, indicating a solid position in the biotech sector. Despite the challenges of achieving profitability, as analysts do not anticipate the company will be profitable this year, Heron has demonstrated a high return over the last year, with a year-to-date price total return of 15.29% and an even more impressive one-year price total return of 99.78%.
From a financial standpoint, Heron's revenue growth remains positive, with the last twelve months as of Q2 2024 showing a 15.6% increase. This growth is consistent with the company's quarterly revenue growth of 13.42% for the same period. However, it is important to note that the company has not been profitable over the last twelve months, with an operating income margin of -21.11% and a return on assets of -22.95%.
InvestingPro Tips highlight that while Heron's stock price movements are quite volatile, the company's liquid assets exceed its short-term obligations, providing a degree of financial stability. Nevertheless, Heron does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income from their investments.
For investors seeking additional insights, there are more InvestingPro Tips available, which delve deeper into the company's financial metrics and market performance. These tips can be an invaluable resource for making informed decisions, and they are accessible through the dedicated InvestingPro platform for Heron Therapeutics at https://www.investing.com/pro/HRTX.
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