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Pacira (PCRX) Gains Positive CHMP Opinion for Exparel in EU
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Pacira BioSciences, Inc. (PCRX - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval for its lead drug Exparel (bupivacaine liposome injectable suspension) as a medicine for postsurgical analgesia. This opinion will now be reviewed by the European Commission with a final decision expected in November 2020.
Per the press release, the CHMP recommended Exparel’s approval as a brachial for treating post-operative pain in adults as well as addressing somatic post-operative pain due to small- to medium-sized surgical wounds in adults.
The CHMP opinion was based on data from four pivotal phase III studies, which evaluated Exparel for the given indication. In all the studies, treatment with Exparel demonstrated improvements in pain reduction and opioid use.
Notably, in June 2019, the EMA accepted Pacira’s Marketing Authorization Application (MAA) for Exparel as a medicine for postsurgical analgesia.
Shares of Pacira have rallied 34.2% so far this year against the industry’s decrease of 6.1%.
We would like to remind investors that Exparel is a liposome injection of bupivacaine, which is indicated for a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States. The drug generated sales worth $176.3 million in the first six months of 2020, down 7.5% year over year.
Last month, the FDA accepted Pacira’s supplemental new drug application (sNDA), which sought Exparel’s label expansion to include single-dose infiltration for providing postsurgical analgesia in children aged six years and above. The regulatory body set a target action date of Mar 22, 2021. There are currently no approved alternatives to opioids for managing severe post-surgical pain in pediatric patients.
Notably, Pacira is advancing Exparel in phase IV studies to expand its utilization in areas like cesarean section, spine and hip fracture. The company’s efforts to widen its label for sales boost are encouraging.
Aldeyra’s loss per share estimates have narrowed 16.4% for 2020 and 21.2% for 2021 over the past 60 days. The stock has rallied 27.9% year to date.
Ironwood’s earnings estimates have moved 27.5% north for 2020 and 22% for 2021 over the past 60 days.
Infinity’s loss per share estimates have narrowed 15.8% for 2020 and 11.6% for 2021 over the past 60 days. The stock has increased 14.6% year to date.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
With users in 180 countries and soaring revenues, it’s set to thrive on remote working long after the pandemic ends. No wonder it recently offered a stunning $600 million stock buy-back plan.
The sky’s the limit for this emerging tech giant. And the earlier you get in, the greater your potential gain.
Image: Bigstock
Pacira (PCRX) Gains Positive CHMP Opinion for Exparel in EU
Pacira BioSciences, Inc. (PCRX - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval for its lead drug Exparel (bupivacaine liposome injectable suspension) as a medicine for postsurgical analgesia. This opinion will now be reviewed by the European Commission with a final decision expected in November 2020.
Per the press release, the CHMP recommended Exparel’s approval as a brachial for treating post-operative pain in adults as well as addressing somatic post-operative pain due to small- to medium-sized surgical wounds in adults.
The CHMP opinion was based on data from four pivotal phase III studies, which evaluated Exparel for the given indication. In all the studies, treatment with Exparel demonstrated improvements in pain reduction and opioid use.
Notably, in June 2019, the EMA accepted Pacira’s Marketing Authorization Application (MAA) for Exparel as a medicine for postsurgical analgesia.
Shares of Pacira have rallied 34.2% so far this year against the industry’s decrease of 6.1%.
We would like to remind investors that Exparel is a liposome injection of bupivacaine, which is indicated for a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States. The drug generated sales worth $176.3 million in the first six months of 2020, down 7.5% year over year.
Last month, the FDA accepted Pacira’s supplemental new drug application (sNDA), which sought Exparel’s label expansion to include single-dose infiltration for providing postsurgical analgesia in children aged six years and above. The regulatory body set a target action date of Mar 22, 2021. There are currently no approved alternatives to opioids for managing severe post-surgical pain in pediatric patients.
Notably, Pacira is advancing Exparel in phase IV studies to expand its utilization in areas like cesarean section, spine and hip fracture. The company’s efforts to widen its label for sales boost are encouraging.
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Aldeyra Therapeutics, Inc. (ALDX - Free Report) , Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and Infinity Pharmaceuticals, Inc. , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aldeyra’s loss per share estimates have narrowed 16.4% for 2020 and 21.2% for 2021 over the past 60 days. The stock has rallied 27.9% year to date.
Ironwood’s earnings estimates have moved 27.5% north for 2020 and 22% for 2021 over the past 60 days.
Infinity’s loss per share estimates have narrowed 15.8% for 2020 and 11.6% for 2021 over the past 60 days. The stock has increased 14.6% year to date.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
With users in 180 countries and soaring revenues, it’s set to thrive on remote working long after the pandemic ends. No wonder it recently offered a stunning $600 million stock buy-back plan.
The sky’s the limit for this emerging tech giant. And the earlier you get in, the greater your potential gain.
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