secwatch.observer — SEC 8-K summary
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Issuer:     Whitehawk Therapeutics, Inc. (WHWK)
CIK:        0001422142
Form:       8-K
Filed at:   2021-11-23T23:59:59+00:00
Accession:  0001193125-21-337294
Event type: regulatory
Sentiment:  positive
Materiality: 0.95
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aadi Bioscience receives FDA approval for FYARRO in advanced malignant PEComa
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1422142/000119312521337294/0001193125-21-337294-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1422142/000119312521337294/d231595d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-337294

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