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Heron's Pain Candidate Meets Endpoint in Pivotal Studies
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Heron Therapeutics, Inc. (HRTX - Free Report) announced that its pipeline candidate, HTX-011, met the primary endpoint in two pivotal phase III studies – EPOCH1 and EPOCH2 – evaluating it in post-operative pain control following bunionectomy and hernia repair, respectively.
Top-line data from both the studies showed that treatment with HTX-011 led to statistically significant reductions in pain intensity and opoid consumption through 72 hours following surgery.
The candidate was also superior to bupivacaine solution, which is the current standard-of carelocal anesthetic for postoperative pain control, Shares of the company surged almost 27% on Monday following the news. Moreover, the company’s shares have returned 50.8% so far this year while the industry declined 1.3% in that period.
Data from the EPOCH1 study showed that HTX-011 reduced pain intensity by 23% compared to placebo and 18% versus bupivacaine solution over 72 hours post bunionectomy. In EPOCH2 study, the reduction in pain intensity in patients treated with HTX-011 versus placebo was also 23% while the pain intensity reduced by 21% compared to bupivacaine solution over 72 hours post hernia repair surgery.
In the EPOCH1 study, patients treated with HTX-001 consumed 37% less opioids compared to patients on placebo and 25% less versus patients receiving bupivacaine solution. Patients treated with HTX-011 in the EPOCH2 study consumed 38% less opioid compared to placebo patients and 25% for patients receiving bupivacaine solution.
Heron plans to file a new drug application with the FDA seeking approval of HTX-011 in the second half of 2018.
Potential approval of HTX-011 will make it a competitor to Pacira Pharmaceuticals, Inc.’s (PCRX - Free Report) non-opioid pain control drug, Exparel, a bupivacaine liposome injectable suspension. HTX-011’s superiority to bupivacaine should help it to gain market share from Exparel.
HTX-011 is also being evaluated in phase II studies for nerve block (breast augmentation) and total knee arthroplasty.
Horizon Pharma’s earnings estimates increased 10% to $1.43 for 2018 and 15% to $1.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Ligand’s earnings per share estimates increased 11% to $4.20 for 2018 and 12% to $5.32 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 24.88%. The company’s shares have increased 23% so far this year.
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And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Heron's Pain Candidate Meets Endpoint in Pivotal Studies
Heron Therapeutics, Inc. (HRTX - Free Report) announced that its pipeline candidate, HTX-011, met the primary endpoint in two pivotal phase III studies – EPOCH1 and EPOCH2 – evaluating it in post-operative pain control following bunionectomy and hernia repair, respectively.
Top-line data from both the studies showed that treatment with HTX-011 led to statistically significant reductions in pain intensity and opoid consumption through 72 hours following surgery.
The candidate was also superior to bupivacaine solution, which is the current standard-of carelocal anesthetic for postoperative pain control, Shares of the company surged almost 27% on Monday following the news. Moreover, the company’s shares have returned 50.8% so far this year while the industry declined 1.3% in that period.
Data from the EPOCH1 study showed that HTX-011 reduced pain intensity by 23% compared to placebo and 18% versus bupivacaine solution over 72 hours post bunionectomy. In EPOCH2 study, the reduction in pain intensity in patients treated with HTX-011 versus placebo was also 23% while the pain intensity reduced by 21% compared to bupivacaine solution over 72 hours post hernia repair surgery.
In the EPOCH1 study, patients treated with HTX-001 consumed 37% less opioids compared to patients on placebo and 25% less versus patients receiving bupivacaine solution. Patients treated with HTX-011 in the EPOCH2 study consumed 38% less opioid compared to placebo patients and 25% for patients receiving bupivacaine solution.
Heron plans to file a new drug application with the FDA seeking approval of HTX-011 in the second half of 2018.
Potential approval of HTX-011 will make it a competitor to Pacira Pharmaceuticals, Inc.’s (PCRX - Free Report) non-opioid pain control drug, Exparel, a bupivacaine liposome injectable suspension. HTX-011’s superiority to bupivacaine should help it to gain market share from Exparel.
HTX-011 is also being evaluated in phase II studies for nerve block (breast augmentation) and total knee arthroplasty.
Heron Therapeutics, Inc. Price
Heron Therapeutics, Inc. Price | Heron Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Heron currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the pharma sector include Horizon Pharma Public Limited Company and Ligand Pharmaceuticals Incorporated (LGND - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Horizon Pharma’s earnings estimates increased 10% to $1.43 for 2018 and 15% to $1.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Ligand’s earnings per share estimates increased 11% to $4.20 for 2018 and 12% to $5.32 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 24.88%. The company’s shares have increased 23% so far this year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>