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Pacira (PCRX) Gets FDA Nod for Exparel's Label Expansion
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Pacira BioSciences, Inc. (PCRX - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) for its marketed product, Exparel, to address a new indication. The latest nod from the regulatory body has expanded the label of Exparel to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
In March 2023, the FDA accepted the sNDA seeking label expansion of Exparel.
The sNDA was based on data from two phase III studies evaluating Exparel versus bupivacaine HCl. The first study evaluated Exparel as a single-dose adductor canal block, while the second study evaluated the drug as a single-dose sciatic nerve block in the popliteal fossa.
Data from the studies showed that treatment with Exparel led to statistically significant and clinically meaningful reductions in postsurgical pain and opioid consumption through 96 hours as compared to bupivacaine HCl – the primary endpoint of the studies.
Also, treatment with Exparel led to statistical significance in reduced postsurgical opioid consumption – the secondary endpoint of the studies. Treatment with Exparel was generally well tolerated, with a safety profile similar to bupivacaine HCl.
Per the press release, the latest label expansion for Exparel is likely to help doctors treat postsurgical pain with long-lasting, non-opioid analgesia with a single dose administration.
Shares of Pacira have plunged 26.2% year to date against the industry’s decrease of 16.4%.
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Pacira’s flagship product, Exparel, was launched in 2012. Exparel (bupivacaine liposome injectable suspension) is indicated for patients aged six years and older for single-dose infiltration to produce postsurgical local analgesia and for adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. The drug has been a consistent revenue driver for the company.
In the first nine months of 2023, Exparel generated sales worth $394.2 million, contributing a major share of PCRX’s top line. Continued label expansion of the drug into additional indications is expected to boost the company’s top line further in 2024 and beyond.
Parica expects Exparel’s net product sales to be in the range of $535-$540 million in 2023.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 24.1%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 46.3%.
Earnings of MEI Pharma beat estimates in each of the trailing four quarters. On average, MEIP came up with a four-quarter earnings surprise of 222.46%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 17.1%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
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Pacira (PCRX) Gets FDA Nod for Exparel's Label Expansion
Pacira BioSciences, Inc. (PCRX - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) for its marketed product, Exparel, to address a new indication. The latest nod from the regulatory body has expanded the label of Exparel to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
In March 2023, the FDA accepted the sNDA seeking label expansion of Exparel.
The sNDA was based on data from two phase III studies evaluating Exparel versus bupivacaine HCl. The first study evaluated Exparel as a single-dose adductor canal block, while the second study evaluated the drug as a single-dose sciatic nerve block in the popliteal fossa.
Data from the studies showed that treatment with Exparel led to statistically significant and clinically meaningful reductions in postsurgical pain and opioid consumption through 96 hours as compared to bupivacaine HCl – the primary endpoint of the studies.
Also, treatment with Exparel led to statistical significance in reduced postsurgical opioid consumption – the secondary endpoint of the studies. Treatment with Exparel was generally well tolerated, with a safety profile similar to bupivacaine HCl.
Per the press release, the latest label expansion for Exparel is likely to help doctors treat postsurgical pain with long-lasting, non-opioid analgesia with a single dose administration.
Shares of Pacira have plunged 26.2% year to date against the industry’s decrease of 16.4%.
Pacira’s flagship product, Exparel, was launched in 2012. Exparel (bupivacaine liposome injectable suspension) is indicated for patients aged six years and older for single-dose infiltration to produce postsurgical local analgesia and for adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. The drug has been a consistent revenue driver for the company.
In the first nine months of 2023, Exparel generated sales worth $394.2 million, contributing a major share of PCRX’s top line. Continued label expansion of the drug into additional indications is expected to boost the company’s top line further in 2024 and beyond.
Parica expects Exparel’s net product sales to be in the range of $535-$540 million in 2023.
Zacks Rank & Stocks to Consider
Parica currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) , MEI Pharma, Inc. (MEIP - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 24.1%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 46.3%.
Earnings of MEI Pharma beat estimates in each of the trailing four quarters. On average, MEIP came up with a four-quarter earnings surprise of 222.46%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 17.1%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.