- 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.
Aurora Mobile Q4 Sales $12.60M Beat $12.32M Estimate
Aurora Mobile (NASDAQ:JG) reported quarterly sales of $12.60 million which beat the analyst consensus estimate of $12.32 million by 2.28 percent. This is a 20.65 percent decrease over sales of $15.88 million the same
