Gossamer Bio reports FDA placed partial clinical hold on all trials of GB5121

In a regulatory filing, Gossamer Bio disclosed that on April 3, the company announced that the U.S. Food and Drug Administration has placed a partial clinical hold on all trials of GB5121, in response to serious adverse events that have been observed in the Phase 1b/2 STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. The company previously announced on March 17 that it had paused enrollment of the Phase 1b/2 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 the foregoing factors, the company has decided to terminate all ongoing studies and discontinue development of GB5121," the filing stated.