---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-065636"
form_type: "8-K"
ticker: "HRTX"
cik: "0000818033"
company_name: "HERON THERAPEUTICS, INC. /DE/"
filed_at: "2024-05-29T23:59:59+00:00"
generated_at: "2026-06-01T07:50:37.792507+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Heron submits PAS to FDA for ZYNRELEF Vial Access Needle to simplify preparation

## Summary
- PAS seeks FDA approval to replace current vented vial spike with new Vial Access Needle (VAN).
- VAN reduces product withdrawal time from up to 3 minutes to 20-45 seconds, simplifying aseptic preparation.
- Heron expects FDA review action date within 4-6 months; decision pending.
- ZYNRELEF is already approved for postoperative pain; VAN addresses healthcare provider feedback.

## SEC filing metadata
- accession: 0000950170-24-065636
- form_type: 8-K
- ticker: HRTX
- cik: 0000818033
- company_name: HERON THERAPEUTICS, INC. /DE/
- filed_at: 2024-05-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/818033/000095017024065636/0000950170-24-065636-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/818033/000095017024065636/hrtx-20240529.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-065636
- JSON: https://secwatch.observer/filing/0000950170-24-065636.json
- Plain text: https://secwatch.observer/filing/0000950170-24-065636.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.