|Over a week ago|
Heron Therapeutics files to sell 12.44M shares of common stock for holders 16:2005/2805/28/21
Heron Therapeutics offers to sell $150M in convertible debt due 2026 » 09:1505/2505/25/21
J. Wood Capital Advisors…
J. Wood Capital Advisors LLC acted as financial advisor and Gibson, Dunn & Crutcher LLP acted as legal advisor to Heron on the transaction.
|Over a month ago|
Landec subsidiary announces Heron received FDA approval for ZYNRELEF » 08:2705/1705/17/21
Lifecore Biomedical, a…
Lifecore Biomedical, a fully-owned subsidiary of Landec (LNDC), announced the receipt by Heron Therapeutics (HRTX), one of Lifecore's customers, of FDA approval for its ZYNRELEF candidate on May 13 for which for Lifecore provides CDMO support. Heron received FDA approval for ZYNRELEF extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Heron Therapeutics announces U.S. FDA approval of ZYNRELEF » 08:0405/1305/13/21
Heron Therapeutics announced that the U.S. FDA has approved ZYNRELEF extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. ZYNRELEF, the first and only extended-release dual-acting local anesthetic, delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam. The synergy between bupivacaine and meloxicam in ZYNRELEF has resulted in patients experiencing significantly less pain, including severe pain, and significantly more patients requiring no opioids after surgery as compared to bupivacaine solution, the current standard-of-care.
Cantor Fitzgerald remains bullish on Heron amid HTX-011 labeling discussions » 10:2705/1005/10/21
Post Q1, Cantor…
Post Q1, Cantor Fitzgerald analyst Brandon Folkes reiterates an Overweight rating and a price target of $26 on Heron Therapeutics' shares. The analyst continues to believe the stock offers investors a favorable risk/reward at current levels. Further, he remains bullish on the peak sales potential for HTX-011 and expects an approval of HTX-011 in 2021. With renewed growth in the CINV franchise and a growing pipeline of products, Folkes believes the company will drive value for investors through not only the launch of HTX-011, but also through the rest of the business. The analyst also highlights that the company noted the are no outstanding questions with the FDA for HTX-011, and is currently in labeling discussions with the FDA.
Heron Therapeutics reports Q1 EPS (58c), consensus (57c) » 08:3705/1005/10/21
Reports Q1 revenue $20M,…
Reports Q1 revenue $20M, consensus $25.73M. "We have no outstanding questions on the pending NDA and are currently in labelling discussions with the FDA, as we prepare for the anticipated commercial launch of HTX-011 in the U.S.," said CEO Barry Quart. "For the oncology care franchise, we expect the market to pick up in the second quarter and we recently signed a large, multi-year contract for CINVANTI that will help increase net product sales throughout 2021."
|Over a quarter ago|
Heron Therapeutics reports Q4 EPS (68c), consensus (65c) » 08:4102/2402/24/21
Reports Q4 revenue…
Reports Q4 revenue $20.6M, consensus $19.14M. As of December 31, 2020, Heron had cash, cash equivalents and short-term investments of $208.5M vs. $391.0M as of December 31, 2019. "We are very pleased that we exceeded our CINV sales guidance for the year, despite 2020 being a challenging year for Heron, with our CINV franchise impacted by both the COVID-19 global pandemic and the EMEND(R) IV generic arbitrage. We also achieved several important milestones in 2020, including the authorization of ZYNRELEF in Europe and the advancement of HTX-034 for postoperative pain and HTX-019 for PONV into clinical development," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We believe that 2021 will be a transformational year for Heron, with significant growth expected in our CINV products with net product sales guidance of $130 million to $145 million, the anticipated FDA approval and commercial launch of HTX-011 in the U.S., and the submission of an NDA for HTX-019 for PONV in the fourth quarter."
Pacira downgraded to Market Perform from Outperform at SVB Leerink » 08:4401/2101/21/21
SVB Leerink analyst Ami…
SVB Leerink analyst Ami Fadia downgraded Pacira (PCRX) to Market Perform from Outperform with a price target of $75, up from $63, following results from her latest MEDACorp physician post-op pain survey. The analyst believes HTX-011 will finally get approval by the May 12 PDUFA date and impact Exparel's growth going forward. Her latest MEDACorp physician post-op pain survey reaffirms prior key opinion leaders' feedback that Exparel growth will be adversely impacted by HTX-011 due to better perceived duration of pain relief, opioid reduction properties, and a lower price point for HTX-011 versus Exparel based on Heron (HRTX) management's commentary. While Exparel has demonstrated good resiliency in the COVID environment, Fadia doesn't believe this means Exparel has an improved competitive moat versus HTX-011 based on physician feedback, and at the current stock price of $73/share, she believes the risk/reward is more balanced at current levels.
Heron Therapeutics' HTX-011 featured in published study » 08:3601/2101/21/21
Heron Therapeutics announced that the results from an EPOCH 1 follow-on study of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association. In this study, 77% of patients receiving HTX-011, along with postoperative over-the-counter oral acetaminophen and ibuprofen, remained opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery. The mean pain intensity never rose above the mild range through 72 hours postoperatively. HTX-011 is a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020.
Heron Therapeutics says NDA resubmission for HTX-011 under review » 08:4201/1101/11/21
The New Drug Application…
The New Drug Application resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. FDA, continues under review. The FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled dose-escalation study in 33 patients undergoing bunionectomy, the reduction in pain intensity observed with the lowest dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus meloxicam and aprepitant) was greater than the bupivacaine 50 mg solution group through 96 hours. In addition, 45.5% of HTX-034 patients remained opioid-free through Day 15 with median opioid consumption of 2.5 milligram morphine equivalents (same as one 5 mg oxycodone pill) through 72-hours, a 71% reduction compared to bupivacaine solution. The expanded Phase 2 portion of the study for HTX-034 will begin this quarter.