regulatory
confidence high
sentiment positive
materiality 0.75
Heron Therapeutics gets FDA approval for ZYNRELEF indication expansion covering 13M annual procedures
HERON THERAPEUTICS, INC. /DE/
- FDA approved supplemental NDA for ZYNRELEF to include soft tissue and orthopedic surgical procedures, including foot and ankle.
- Expanded indication now covers an estimated 13 million procedures annually, an 86% increase over prior indicated procedures.
- No unique safety issues identified in new clinical trials for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.
- CEO Craig Collard highlights label expansion, CrossLink partnership, and potential VAN approval as transformative for ZYNRELEF.