Gossamer Bio drops development of GB5121

The US Food and Drug Administration (FDA) has placed a partial clinical hold on all trials of Gossamer Bio’s (Nasdaq: GOSS) GB5121, in response to serious adverse events that have been observed in the Phase Ib/II STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage.

The San Diego, USA company, whose shares closed down more than 9% at $1.02 following the revelation, previously announced on March 17, 2023 that it had paused enrollment of the Phase Ib/II STAR-CNS study based on the benefit / risk profile observed to date and a prioritization of resources to support the company’s seralutinib program.

Based on these factors, the company disclosed in a filing with the Securities and Exchange Commission (SEC) that it has decided to terminate all ongoing studies and discontinue development of GB5121.