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Heron Therapeutics, Inc. (Nasdaq: HRTX) is a leading commercial-stage biotechnology company focused on enhancing patient care through the development and commercialization of innovative therapeutic solutions. Specializing in the use of its proprietary Biochronomer™ polymer-based drug delivery platform, Heron is revolutionizing the pharmaceutical landscape by converting daily injectable drugs into weekly or bi-weekly regimens.
The company's product portfolio includes APONVIE, SUSTOL, ZYNRELEF, and CINVANTI, which target unmet medical needs in both acute care and oncology settings. APONVIE is effective in preventing postoperative nausea and vomiting, offering a quick 30-second IV push that is bioequivalent to oral aprepitant. SUSTOL utilizes Heron's Biochronomer® technology to extend therapeutic levels of granisetron for over five days, aiding in the prevention of chemotherapy-induced nausea and vomiting (CINV).
ZYNRELEF, a dual-acting local anesthetic combining bupivacaine and meloxicam, is notably the first extended-release local anesthetic demonstrating superior pain management and reducing opioid use for up to 72 hours post-surgery. Originally approved by the FDA in May 2021, its indication was expanded in January 2024 to cover various soft tissue and orthopedic surgeries. Recently, Heron submitted a Prior Approval Supplement (PAS) for a Vial Access Needle to streamline ZYNRELEF's preparation process, potentially enhancing its adoption in clinical settings.
CINVANTI, an IV formulation of aprepitant, significantly reduces both acute and delayed phases of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy, improving overall patient quality of life during treatment.
Financially, Heron Therapeutics is on a robust trajectory, having implemented a cost reduction program projected to save approximately $75 million through 2025. The company has secured $30 million in equity financing and a $50 million working capital facility, aiming to achieve profitability with its current operational strategies.
Heron’s strong focus on clinical excellence and strategic partnerships, such as its recent collaboration with CrossLink Life Sciences to expand ZYNRELEF's sales network, underscores its commitment to delivering substantial value and improving patient outcomes. For more detailed information, visit herontx.com.
Heron Therapeutics (Nasdaq: HRTX) announced that the FDA accepted its Prior Approval Supplement (PAS) application for ZYNRELEF® (bupivacaine and meloxicam) with a goal decision date of September 23, 2024. The new Vial Access Needle (VAN) aims to replace the current vented vial spike, simplifying preparation and reducing withdrawal time from up to three minutes to 20-45 seconds. If approved, VAN is expected to be available in Q4 2024. Additionally, Heron’s partnership with CrossLink Life Sciences aims to bolster ZYNRELEF's promotion by adding approximately 650 representatives by year’s end, targeting orthopedic surgeons nationwide.
Heron Therapeutics announced the submission of a Prior Approval Supplement (PAS) to the FDA for the ZYNRELEF Vial Access Needle (VAN). The VAN aims to replace the current vented vial spike (VVS) in ZYNRELEF kits, reducing preparation time significantly from up to 3 minutes to 20-45 seconds. The VAN's user-friendly design is expected to simplify aseptic preparation and potentially increase adoption. FDA review completion is anticipated within 4-6 months. ZYNRELEF, approved in May 2021, is noted for its efficacy in postoperative pain management compared to bupivacaine solution, showing lower pain scores and reduced opioid consumption.
Heron Therapeutics, Inc. (Nasdaq: HRTX) reported strong financial results for Q1 2024, including a 17% increase in Net Product Sales to $34.7 million and a significant improvement in Gross Margin to 76%. The company also announced a partnership with CrossLink Life Sciences, to boost ZYNRELEF® promotional efforts and FDA approval for an expanded indication for ZYNRELEF. Heron will host its first Investor Day event on May 15, 2024, in New York. The company reaffirmed its financial guidance for 2024, expecting promising growth across its Acute Care and Oncology franchises.
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