Heron Therapeutics Inc (NASDAQ:HRTX) announced that the U.S. Food and Drug Administration(FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).
“Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,” commented Ralph V. Boccia, MD, FACP, Medical Director,Center for Cancer and Blood Disorders. “In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. SUSTOL, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days.”
The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical trials that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2-5 following chemotherapy).
“The SUSTOL clinical trial populations and results are highly representative of cancer patients in our real-world clinical practice,” said Jeffrey Vacirca, MD, FACP, Chief Executive Officer and Director of Clinical Research, North Shore Hematology Oncology Associates and Vice President, Community Oncology Alliance. “Use of MEC regimens is widespread, and AC-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens. The most significant challenge for my breast cancer patients receiving AC is chemotherapy-induced nausea and vomiting. SUSTOL represents a better option to manage this devastating side effect of therapy.”
“We would like to thank the investigators, caregivers and most of all the patients who have helped us to achieve this important milestone,” commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. “In addition to bringing an important product to patients, we are extremely pleased to have obtained the first approval of a product utilizing Heron’s Biochronomer polymer-based drug delivery technology.”
“The approval of SUSTOL is a major step in Heron’s evolution into a fully-integrated biopharmaceutical company with both development and commercial capabilities,” said Robert H. Rosen, President of Heron Therapeutics. “Our focus now turns to ensuring patients have access to this important therapy. We look forward to collaborating with the oncology community to make SUSTOL available in the fourth quarter of this year.” (Original Source)
Shares of Heron Therapeutics closed yesterday at $19.86, up $1.12 or 6%. HRTX has a 1-year high of $42.25 and a 1-year low of $15.22. The stock’s 50-day moving average is $17.63 and its 200-day moving average is $18.84.
On the ratings front, HRTX has been the subject of a number of recent research reports. In a report released yesterday, Cantor Fitzgerald analyst Chiara Russo reiterated a Buy rating on HRTX, with a price target of $38, which represents a potential upside of 91.3% from where the stock is currently trading. Separately, on the same day, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $55.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chiara Russo and Jonathan Aschoff have a total average return of 1.5% and -10.6% respectively. Russo has a success rate of 54.8% and is ranked #1655 out of 4110 analysts, while Aschoff has a success rate of 35.9% and is ranked #4001.
The street is mostly Bullish on HRTX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $46.50, which represents a potential upside of 134.1% from where the stock is currently trading.
Heron Therapeutics, Inc. is a biotechnology company develops pharmaceutical products for patients suffering from cancer or pain. The company develops products by using its proprietary Biochronomer polymer based drug delivery technology. Its primary products are SUSTOL, HTX-019 and HTX-011. The company has additional clinical and preclinical-stage programs in the area of pain management, all of which utilize its bioerodible, injectable and implantable delivery systems.