By Chris Wack


Heron Therapeutics shares were up 15% to $2.53 after the U.S. Food and Drug Administration approved its supplemental new drug application for Zynrelef extended-release solution.

The biotechnology company said the approval expands the indication for Zynrelef for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.

Zynrelef was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

This expanded indication for Zynrelef will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures.

To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience after use of Zynrelef.

Zynrelef was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-24-24 1035ET