secwatch.observer — SEC 8-K summary
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Issuer:     HERON THERAPEUTICS, INC. /DE/ (HRTX)
CIK:        0000818033
Form:       8-K
Filed at:   2024-07-02T23:59:59+00:00
Accession:  0000950170-24-080026
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Heron Therapeutics announces FDA acceptance of ZYNRELEF VAN supplement; PDUFA goal date September 23, 2024
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- FDA acknowledged receipt of Prior Approval Supplement for ZYNRELEF Vial Access Needle (bupivacaine/meloxicam); PDUFA goal date September 23, 2024.
- If approved, VAN would replace vented vial spike, reducing withdrawal time from up to 3 minutes to 20-45 seconds.
- VAN expected to be available in Q4 2024 if approved; CrossLink partnership on track to add ~650 representatives by year-end.
- CEO Craig Collard expressed optimism that VAN and CrossLink partnership could increase adoption among orthopedic surgeons.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/818033/000095017024080026/0000950170-24-080026-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/818033/000095017024080026/hrtx-20240702.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-080026

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer