Pacira (PCRX) Gets Positive CHMP View on Exparel Label Expansion
Pacira BioSciences, Inc. PCRX announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on its marketed product Exparel and recommended marketing authorization for the same to treat postsurgical pain in children aged six years and above.
The CHMP recommended approval for Exparel as a field block to treat somatic post-operative pain from small to medium-sized surgical wounds in children aged six years and older.
A final decision from the European Commission (“EC”) on the marketing authorization application for the label expansion of Exparel is expected in November 2022.
Shares of Pacira have lost 8.6% this year so far compared with the industry’s decline of 25.1%.
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We remind investors that the EC granted marketing authorization to Exparel as a brachial plexus block or femoral nerve block for treating postoperative pain in adults and as a field block for the treatment of somatic post-operative pain from small to medium-sized surgical wounds in adults in November 2020.
Following the nod, Exparel became the first long-acting non-opioid option for field block and brachial plexus or femoral nerve block approved in Europe.
Exparel, a liposome injection of bupivacaine, is indicated for a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States.
In March 2021, the FDA approved Pacira’s supplemental new drug application seeking approval of Exparel for use in children aged six years and above.
Pacira’s flagship product Exparel has witnessed a strong uptake since its launch and has been its constant revenue driver thereafter. The drug generated sales worth $266.2 million in the first six months of 2022, reflecting an increase of almost 8.7% year over year.
Successful label expansion of Exparel into additional indications is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Aptose Biosciences Inc. APTO, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, 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.
Aptose Biosciences’ loss per share estimates has narrowed 14% for 2022 and 10% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates has narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed the mark on a single occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates has narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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