FDA Capitulation is a Huge Victory for Pacira (PCRX) - Wedbush

Wedbush analyst, Liana Moussatos, highlighted the importance of the FDA rescinding its warning letter for Pacira Pharmaceuticals (NASDAQ: PCRX) EXPAREL. On December 14th, the FDA sent Pacira a letter formerly rescinding its warning letter from late 2014. The analyst also increased her price target to $123 from $113.

In the letter the FDA indicated that the approval of EXPAREL in 2011 was not limited to bunionectomy and hemorrhoidectomy, and it could be used in all infiltration settings in adults. In addition to reaffirming EXPAREL’s broad indication, the FDA also explicitly provided guidance for the use of EXPAREL for post-surgical analgesia for TAP block and oral surgical procedures. With the explicit approval of EXPAREL in oral surgery, Pacira has changed the launch timing for EXPAREL in this indication from Q1:17 to late Q3:16.

As a part of rescinding the warning letter, the FDA provided an updated prescribing label for EXPAREL (new label). In several ways the new label is better with the removal of ambiguous language potentially limiting the scope of use for EXPAREL and the addition of clear language that reaffirms the approval of EXPAREL in a variety of surgical settings.

These improvements to the label should ease restriction on the use of EXPAREL by hospital administrators. This a huge victory for Pacira, we believe the company will have to expend capital to reeducate surgeons and hospital administrators on EXPAREL and do not anticipate seeing results from the improved label until late 2016.

For an analyst ratings summary and ratings history on Pacira Pharmaceuticals click here. For more ratings news on Pacira Pharmaceuticals click here.

Shares of Pacira Pharmaceuticals closed at $70.89 yesterday.

You May Also Be Interested In

• BOK Financial (BOKF) PT Raised to $97 at DA Davidson
• Boston Scientific (BSX) PT Raised to $77 at Oppenheimer
• CONMED (CNMD) PT Lowered to $95 at Piper Sandler