After Pausing Recruitment, Gossamer Bio Terminates All Studies With CNS Lymphoma Candidate
The FDA placed a partial clinical hold on Gossamer Bio Inc's (NASDAQ: GOSS) all trials of GB5121 in response to serious adverse events 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 that it had paused enrollment in the Phase 1b/2 STAR-CNS Study based on the benefit/risk profile observed to date and a prioritization of resources to support its seralutinib program.
Also Read: Analyst Downgrades Gossamer Bio As Merck's Sotatercept Might Overshadow Seralutinib's Success.
Based on the preceding factors, the company has decided to terminate all ongoing studies and discontinue the development of GB5121.
Seralutinib (GB002) is under development for Pulmonary Arterial Hypertension (PAH)
Upon completing the 24-week blinded portion of the Phase 2 TORREY Study, patients could enroll in an open-label extension trial with results expected in mid-2023.
A Phase 3 PAH clinical trial for Seralutinib is expected to start in 2H of 2023.
The company ended 2022 with cash, cash equivalents & marketable securities of $255.7 million, providing a cash runway into the second half of 2024.
Price Action: GOSS shares are down 3.71% at $1.08 on the last check Tuesday.
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
This article After Pausing Recruitment, Gossamer Bio Terminates All Studies With CNS Lymphoma Candidate originally appeared on Benzinga.com
.
Ā© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
