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Pacira (PCRX) Gets European Commission Approval for Exparel

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Pacira BioSciences, Inc. PCRX announced that the European Commission has granted marketing authorization to Exparel as a brachial plexus block or femoral nerve block for the treatment of post-operative 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.Exparel is the first long-acting non-opioid option for field block and brachial plexus or femoral nerve block approved in Europe.

Shares of Pacira have surged 42.9% so far this year against the industry’s decline of 3.7%.

The approval was supported by results from four pivotal phase III studies that demonstrated improvements in pain reduction and opioid use following surgery. The company expects to launch Exparel in the second half of 2021.

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.

In August 2020, 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 #4 (Sell). 

Some better-ranked stocks in the biotech sector are Cassava Sciences SAVA, BioLineRx Ltd. BLRX and Catalent Inc. CTLT. All stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cassava’s loss per share estimates have narrowed from 26 cents to 21 cents for 2020 in the past 60 days. Shares of the company have increased 43.8% year to date.

BioLineRx’sloss per share estimates have narrowed from $1.95 to $1.67 for 2020 and from $1.44 to $1.36 for 2021 in the past 60 days. Shares of the company have decreased 2.3% year to date.

Catalent’s earnings per share estimates have increased from $2.41 to $2.51 for 2020 and from $2.82 to $2.93 for 2021 in the past 60 days. Shares of the company have decreased 83.2% year to date.

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BioLineRx Ltd. (BLRX) : Free Stock Analysis Report
 
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