---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-337294"
form_type: "8-K"
ticker: "WHWK"
cik: "0001422142"
company_name: "Whitehawk Therapeutics, Inc."
filed_at: "2021-11-23T23:59:59+00:00"
generated_at: "2026-06-28T05:44:03.514601+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Aadi Bioscience receives FDA approval for FYARRO in advanced malignant PEComa

## Summary
- FDA approved FYARRO (sirolimus protein-bound particles) for adult patients with advanced unresectable or metastatic malignant PEComa.
- FYARRO is the first and only FDA-approved treatment for advanced malignant PEComa, an ultra-rare sarcoma.
- In pivotal AMPECT trial, overall response rate was 39% (12/31); median duration of response not reached after median 36-month follow-up.
- Launch planned for Q1 2022; investor conference call scheduled for today at 8:30 am ET.

## SEC filing metadata
- accession: 0001193125-21-337294
- form_type: 8-K
- ticker: WHWK
- cik: 0001422142
- company_name: Whitehawk Therapeutics, Inc.
- filed_at: 2021-11-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1422142/000119312521337294/0001193125-21-337294-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1422142/000119312521337294/d231595d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-337294
- JSON: https://secwatch.observer/filing/0001193125-21-337294.json
- Plain text: https://secwatch.observer/filing/0001193125-21-337294.txt

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