Gossamer Bio discontinues GB5121 after FDA partial clinical hold; SAEs included fatal hemorrhage

Gossamer Bio, Inc.

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.

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