secwatch.observer — SEC 8-K summary
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Issuer:     Gossamer Bio, Inc. (GOSS)
CIK:        0001728117
Form:       8-K
Filed at:   2023-04-03T23:59:59+00:00
Accession:  0001728117-23-000030
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Gossamer Bio discontinues GB5121 after FDA partial clinical hold; SAEs included fatal hemorrhage
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- FDA placed partial clinical hold on all GB5121 trials after atrial fibrillation, sudden death, and fatal intracranial hemorrhage in STAR-CNS study.
- Company terminated all ongoing GB5121 studies and discontinued development of the drug.
- Enrollment had been paused March 17, 2023, based on benefit/risk and to prioritize seralutinib program.
- No other pipeline updates disclosed; seralutinib remains the priority program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1728117/000172811723000030/0001728117-23-000030-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1728117/000172811723000030/goss-20230403.htm
  HTML page:      https://secwatch.observer/filing/0001728117-23-000030

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