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PCRX

Pacira

$36.10

0.2 (0.56%)

15:37
02/15/18
02/15
15:37
02/15/18
15:37

Pacira 'confident' data supports Exparel label expansion despite 4-6 panel vote

Pacira Pharmaceuticals announced that the U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of Exparel as a nerve block to produce regional analgesia. The committee's feedback will be considered by the FDA in its review of the company's sNDA seeking expansion of the Exparel label. The Prescription Drug User Fee Act, or PDUFA, date for completion of the review is April 6, 2018. Four committee members voted to recommend FDA approval of the Exparel sNDA while six believed that more research is needed to further support the proposed new indication. "We remain confident that the data from our clinical program provides all of the necessary information to support expansion of the current Exparel label for infiltration to also include use as a nerve block for regional analgesia. We look forward to working with the FDA to address any outstanding questions as we move through the sNDA review process toward our ultimate goal of offering additional flexibility in the way Exparel can be administered so that clinicians and patients alike have increased opportunity to realize the benefits of long-lasting non-opioid pain control," said Dave Stack, chairman and CEO at Pacira.

  • 15

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    Apr

PCRX Pacira
$36.10

0.2 (0.56%)

02/13/18
PIPR
02/13/18
NO CHANGE
Target $49
PIPR
Overweight
Pacira briefing materials 'clearly a mixed bag,' says Piper Jaffray
Briefing materials for the upcoming meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee to discuss Pacira Pharmaceuticals' filing for Exparel administration via upper and lower extremity nerve block were "clearly a mixed bag," Piper Jaffray analyst David Amsellem tells investors in a research note. He believes this is not a surprise since the results of the studies supporting the filing were a "mixed bag." The analyst's read of the documents suggests that a label expansion in femoral nerve block is "likely off the table." That said, the documents did not focus significantly on the successful upper extremity study, and the voting questions clearly leave open the possibility of a narrow label expansion, Amsellem contends. He reiterates an Overweight rating on Pacira with a $49 price target.
02/12/18
BMOC
02/12/18
NO CHANGE
BMOC
Market Perform
BMO says Pacira briefing docs reveal 'several uncertainties' for Exparel
BMO Capital analyst Gary Nachman said his quick review of the FDA's analysis and draft questions for the upcoming advisory committee meeting reveal "several uncertainties" about Exparel in terms of consistency across studies and how the drug compares with IR bupivacaine. On efficacy, the FDA "appears to be cautious" about providing a broad label for nerve block, said Nachman, who keeps a Market Perform rating on Pacira shares.
02/07/18
PIPR
02/07/18
NO CHANGE
Target $49
PIPR
Overweight
Piper 'cautiously optimistic' into Pacira FDA advisory panel
Piper Jaffray analyst David Amsellem remains "cautiously optimistic" on a favorable outcome into the FDA's Anesthetic and Analgesic Drug Products Advisory Committee meeting on February 14 and 15 to discuss Pacira Pharmaceuticals' supplemental new drug application filing for Exparel administration via upper and lower extremity nerve block. The analyst continues to believe that Exparel, even without a label expansion, is well positioned for "significant and sustainable" growth. He reiterates an Overweight rating on Pacira with a $49 price target.
01/19/18
GHSC
01/19/18
INITIATION
Target $51
GHSC
Buy
Pacira initiated with a Buy at Seaport Global
Seaport Global analyst Corey David initiated Pacira with a Buy and $51 price target. The analyst believes Exparel growth rates have bottomed and will begin to reaccelerate in 2018.

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