Shares of Pacira (PCRX) after jumping after Heron Therapeutics (HRTX) received a Complete Response Letter from the FDA regarding its new drug application for HTX-011 for the management of postoperative pain. HTX-011 is a potential competitor to Pacira’s pain treatment Exparel. The CRL to Heron stated that the FDA is unable to approve the new drug application in its present form based on the need for additional manufacturing and non-clinical information, Heron said this morning in statement. “Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses,” the company added. In premarket trading, Pacira shares are up 14% to $45.39 while Heron shares are down 24% to $16.55.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.