FDA Okays Label Expansion Of Pacira's Exparel's, Stock Up
Zacks Investment Research | Apr 09, 2018 05:15AM ET
Shares of Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) moved up more than 13% on Friday after the company announced that the FDA has approved approved the label expansion of its flagship product, Exparel.
The FDA approved Pacira’s supplemental new drug application (sNDA) seeking expansion of the Exparel (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. However, the FDA’s approval came as a surprise after an FDA Committee voted six to four against approval of the expanded indication in February.
With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.
Exparel is a liposome injection of bupivacaine, which is indicated for single-dose administration into the surgical site to produce post-surgical analgesia.
The approval will allow clinicians to potentially do away with the need for cumbersome catheters and pumps that are used to extend the duration of regional analgesia.
Over the year, Pacira’s shares have declined 27.7%, against the industry ’s gain of 4.3%.
We remind investors that Pacira had received a complete response letter from the FDA in 2015, following a review of its sNDA for the use of Exparel in nerve block to provide postsurgical analgesia. The FDA then requested another clinical trial to be conducted to establish the efficacy of Exparel in an additional clinical setting beyond femoral nerve block for total knee arthroplasty. However, the FDA accepted the company’s resubmission of its sNDA in October 2017.
The sNDA was based on the positive data from a phase III study of Exparel in femoral nerve block for TKA (lower extremity) and a phase III study of Exparel in brachial plexus block for shoulder surgeries (upper extremity). It also included safety and pharmacokinetic data through 120 hours.
Zacks Rank and Stocks to Consider
Pacira carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the same space are Regeneron Pharmaceuticals (NASDAQ:REGN) , Enanta Pharma (NASDAQ:ENTA) and Ligand Pharmaceuticals (NASDAQ:LGND) . All of them sport a Zacks Rank #1 (Strong Buy). You can see .
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Regeneron’s earnings per share estimates have moved up from $18.67 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares have surged 171.8% over a year.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 47% over a year.
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