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 (HRTX) announced the relocation of its corporate headquarters from San Diego, California to Cary, North Carolina, effective January 1, 2025. The new headquarters will be located near the Research Triangle Park (RTP), positioning the company within one of the most prominent high-tech R&D parks in the US. The move is strategic as a majority of Heron's Management Team and corporate employees already work from the Cary office.
CEO Craig Collard highlighted that the relocation will centralize operations and resources while facilitating strategic partnerships. The new headquarters will be situated at 100 Regency Forest Drive, Suite 300, Cary, NC 27518. The location provides ample space for growth and expansion within the growing biotech community.
Heron Therapeutics (HRTX) announced a favorable ruling from the U.S. District Court for the District of Delaware in its patent litigation against Fresenius Kabi USA. The court upheld the validity of Heron's patents (U.S. Patent Nos. 9,561,229 and 9,974,794) for CINVANTI® injectable emulsion, which expire in 2035, and found they would be infringed by Fresenius' proposed generic product.
The litigation began in July 2022 after Fresenius submitted an Abbreviated New Drug Application seeking approval for a generic version of CINVANTI®. Heron will now seek a court order to prevent Fresenius from launching its generic version until the patents expire in 2035.
Heron Therapeutics reported positive YTD 2024 Adjusted EBITDA of $1.4 million and narrowed its financial guidance for Q4 2024. The company expects Q4 2024 Net Revenue between $37-43 million. Key developments include FDA approval of ZYNRELEF's Vial Access Needle in September and its inclusion in CMS Final Rule Non-Opioid Policy for Pain Relief. For Q3 2024, acute care franchise sales reached $7.4 million, while oncology care franchise reported $25.4 million. The company's cash position stood at $70.9 million as of September 30, 2024.
Heron Therapeutics (HRTX) has appointed Michael Kaseta to its Board of Directors. Kaseta currently serves as CFO and COO of Liquidia and brings extensive experience in corporate finance, business strategy, and biopharma product commercialization. His previous roles include CFO positions at Aerami Therapeutics and Aralez Pharmaceuticals, as well as CFO at Sanofi North America, where he managed a $10 billion business across eight therapeutic areas. Kaseta holds a BBA in accounting from James Madison University and is a CPA.
Heron Therapeutics (HRTX) has scheduled its third quarter 2024 financial results conference call and webcast for Tuesday, November 12, 2024, at 8:00 a.m. ET. The event will include a discussion of recent business highlights. Participants are encouraged to dial in fifteen minutes before the start time to avoid delays. The webcast will be available under the Investor Relations section of Heron's website, with a replay accessible for 60 days following the call.
Heron Therapeutics (Nasdaq: HRTX) has reaffirmed its ability to supply CINVANTI®, SUSTOL®, and APONVIE® as alternatives during a potential shortage of intravenous (IV) fluids caused by Hurricane Helene. These products are ready-to-administer formulations that don't require additional dilution with IV fluids, making them important during this potential shortage.
The IV fluid shortage is expected due to the temporary closure of a major supplier's manufacturing site in Marion, North Carolina, which reportedly supplies up to 60% of the U.S. IV fluid market. Heron has received outreach from several health systems preparing to maintain continuity of care. The company is committed to ensuring timely delivery of its products throughout the U.S. during this potential shortage.
Heron Therapeutics (Nasdaq: HRTX) announced FDA approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle (VAN). The VAN, expected to launch in Q4 2024, aims to simplify aseptic preparation and reduce withdrawal time to 20-45 seconds. It replaces the current vented vial spike with a user-friendly 'container-like' design, potentially enhancing safe use, increasing adoption, and improving preparation.
Bill Forbes, EVP and Chief Development Officer, highlighted the VAN's potential to address adoption hurdles and reduce preparation time. CEO Craig Collard noted that the VAN approval, along with ZYNRELEF's label expansion, inclusion in the proposed 2025 NOPAIN Act, and partnership with CrossLink Life Sciences, are key milestones for ZYNRELEF's progress in 2024.
Heron Therapeutics (Nasdaq: HRTX) has appointed Brett Fleshman as Chief Business Officer. With 25 years of experience in corporate and business development, commercial strategy, and marketing, Fleshman is expected to drive inorganic revenue growth and expand investor relations. CEO Craig Collard emphasized the timing for adding substantial BD and M&A experience to the management team.
Fleshman's background includes roles at NovaQuest Capital Management, Veloxis Pharmaceuticals, and Cornerstone Therapeutics, where he contributed to successful turnarounds and acquisitions. His focus has been on developing efficient strategies for commercializing new products and revitalizing distressed assets. Fleshman's appointment aims to leverage Heron's established commercial team in hospital and community settings.
Heron Therapeutics (Nasdaq: HRTX) announced its Q2 2024 financial results, reporting Net Product Sales of $36.0 million, up from $31.8 million in Q2 2023. The ZYNRELEF VAN PDUFA goal date is set for September 23, 2024, with anticipated launch before year-end. The company's adjusted operating expenses guidance for 2024 is narrowed to $107.0-$111.0 million, and adjusted EBITDA guidance is revised to $(10.0) to $3.0 million. ZYNRELEF is also included in the proposed 2025 NOPAIN Act, effective April 1, 2025.
For the six months ended June 30, 2024, acute care franchise net product sales were $12.3 million, up from $8.3 million in 2023. Oncology care franchise net product sales were $58.4 million, up from $53.1 million for the same period in 2023.
Heron continues to train CrossLink sales reps for ZYNRELEF, with 561 reps trained to date. The company’s financial efficiency is improving, with increasing revenues and decreasing expenses.
Heron Therapeutics (Nasdaq: HRTX), a commercial-stage biotechnology company, has announced it will host a conference call and live webcast on Tuesday, August 6, 2024, at 4:30 p.m. ET to report its second quarter 2024 financial results and discuss recent business highlights. Investors and interested parties can access the call by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally, using the passcode 1737564. A webcast will also be available under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will be accessible on the company's website for 60 days following the call.