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The FDA has approved Heron Therapeutics Inc’s (NASDAQ:HRTX) supplemental New Drug Application for Zynrelef (bupivacaine and meloxicam) extended-release solution to expand the indication 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 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 following Zynrelef administration.
“The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle (“VAN”) later this year, are expected to have a significant positive impact for Zynrelef and the Company,” said Craig Collard, Chief Executive Officer of Heron.
Zynrelef is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care.
Zynrelef demonstrated superiority compared to bupivacaine, with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption.
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.
Price Action: HRTX shares are up 5.91% at $2.33 on the last check Wednesday.
Posted In: HRTX
