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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 (HRTX) has announced a private placement of $150 million in senior unsecured convertible promissory notes, converting at a price of $15.276 per share, a 13% premium. Proceeds will fund the launch of ZYNRELEF, an FDA-approved dual-acting local anesthetic for postoperative pain. The notes accrue 1.5% interest, maturing on June 1, 2026. The company anticipates that these funds will enable ZYNRELEF's launch and help achieve profitability. ZYNRELEF has also received formulary approval shortly after FDA approval.
Heron Therapeutics announced FDA approval of ZYNRELEF (bupivacaine and meloxicam), extending postoperative pain management up to 72 hours after surgeries like bunionectomy and total knee arthroplasty. This first-in-class dual-acting local anesthetic significantly reduces pain and opioid usage, offering a vital alternative amid rising opioid-related deaths. The company plans to leverage its existing commercial team for a robust launch by July 2021, following successful Phase 3 trials that included over 1,000 patients. This approval could reshape the postoperative pain management landscape.
Heron Therapeutics (HRTX) reported financial results for Q1 2021, indicating a decline in net product sales to $20.0 million, down from $25.4 million in Q1 2020. The company's net loss was $52.6 million or $0.58 per share, slightly higher than $51.6 million in the prior year. Notable updates include the ongoing NDA review for HTX-011 with a PDUFA goal date of May 12, 2021, and a planned NDA for HTX-019 later in 2021. Heron anticipates a recovery in oncology sales due to improved patient access to treatments as COVID-19 restrictions ease.
Heron Therapeutics (Nasdaq: HRTX) reported its financial results for 2020, with net product sales of $88.6 million, down from $146.0 million in 2019. The net loss increased to $227.3 million or $2.50 per share. The company highlighted ongoing reviews for HTX-011 and the anticipated NDA for HTX-019, with a projected sales guidance of $130 million to $145 million for the CINV franchise in 2021. Heron ended the year with $208.5 million in cash and expects this to sustain operations into 2022.
Heron Therapeutics, Inc. (Nasdaq: HRTX), a biotechnology company focused on enhancing patient care, announced that CEO Barry Quart will present at two key virtual investor conferences. The presentations are scheduled for the SVB Leerink 10th Annual Global Healthcare Conference on February 24, 2021, at 5:00 pm ET, and the Cowen 41st Annual Healthcare Conference on March 1, 2021, at 11:40 am ET. Live webcasts will be available on the company's website, with replays accessible for 60 days. Heron is dedicated to addressing significant patient needs, particularly in pain and cancer management.
Heron Therapeutics (Nasdaq: HRTX) announced the publication of the EPOCH 1 follow-on study results in the Journal of the American Podiatric Medical Association. The study demonstrated that 77% of bunionectomy patients treated with HTX-011, a dual-acting local anesthetic, remained opioid-free for 28 days post-surgery. Patients reported mild pain intensity and significant pain reduction compared to standard treatments. HTX-011 was well tolerated, with a safety profile similar to placebo. The FDA has granted Breakthrough Therapy designation for HTX-011, with an NDA review goal set for May 12, 2021.
Heron Therapeutics (Nasdaq: HRTX) announced progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises, alongside a new program targeting postoperative nausea and vomiting (PONV). The FDA is reviewing the NDA for HTX-011, with a decision expected by May 12, 2021. Preliminary Q4 2020 net sales for CINV reached $20.3 million, while full-year guidance for 2021 is set between $130 million and $145 million. Notably, HTX-019 showed bioequivalence to oral aprepitant, with an NDA anticipated later in 2021.
Heron Therapeutics (HRTX) has resubmitted its New Drug Application (NDA) for HTX-011 to the FDA, addressing issues outlined in a Complete Response Letter from June 2020. The resubmission follows a Type A End-of-Review meeting in September, where the FDA agreed with Heron's proposed changes. HTX-011 is a non-opioid analgesic intended for postoperative pain management. The FDA will classify this as a Class 2 resubmission, allowing up to six months for review. HTX-011 has received Breakthrough Therapy and Priority Review designations.
Heron Therapeutics, Inc. (Nasdaq: HRTX) announced that CEO Barry Quart will present at three upcoming virtual investor conferences. The events include the Stifel 2020 Virtual Healthcare Conference on November 17 at 3:20 pm ET, the Jefferies Virtual London Healthcare Conference on November 19 at 1:30 pm GMT, and the 3rd Annual Evercore ISI HealthCONx Conference on December 1 at 4:20 pm ET. Each presentation will be webcast live and available for replay for 60 days on their website.
Heron Therapeutics (HRTX) reported Q3 and nine-month results for 2020, showing net product sales of $20 million and $68 million, down from $42.6 million and $110.9 million in 2019. The company announced a marketing authorization for ZYNRELEF in the EU and successful FDA meeting for HTX-011 resubmission. Heron raised its 2020 CINV sales guidance from $70-$80 million to $85 million, despite challenges from COVID-19. Net loss increased to $58.2 million for Q3 and $165 million for the nine months. As of September 30, 2020, cash reserves totaled $258.1 million, expected to sustain operations into 2022.
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