Welcome to our dedicated page for Heron Therapeutics news (Ticker: HRTX), a resource for investors and traders seeking the latest updates and insights on Heron Therapeutics stock.
Heron Therapeutics, Inc. reports commercial and financial developments for a commercial-stage biotechnology business focused on acute care and oncology products. News commonly covers revenue performance and guidance for the Acute Care franchise, including ZYNRELEF and APONVIE, as well as oncology product updates involving CINVANTI and the broader product portfolio.
Company updates also address APONVIE’s role as an FDA-approved IV NK-1 receptor antagonist for prevention of postoperative nausea and vomiting in adults, ZYNRELEF product-handling initiatives for hospital and ambulatory surgical center use, distribution and sales-force activity, intellectual-property matters, and board or governance changes.
Heron Therapeutics announced that ZYNRELEF, its non-opioid pain relief product, is included in the proposed 2025 Non-Opioid Policy for Pain Relief under Medicare's OPPS and ASC payment systems. This inclusion, effective April 1, 2025, allows ZYNRELEF to maintain separate reimbursement in hospital outpatient departments and ambulatory surgical centers without disruption after its current pass-through payment status expires on March 31, 2025.
The proposed rule by CMS qualifies ZYNRELEF based on its postoperative pain indication and potential to reduce opioid use. For 2025, CMS proposed that payments for qualifying drugs like ZYNRELEF will remain at average sales price plus six percent. Heron expects most commercial payers to follow CMS's policy, potentially expanding access to non-opioid postsurgical pain management options.
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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