other material
confidence high
sentiment positive
materiality 0.75
GT Biopharma receives FDA clearance for IND of GTB-3650; Phase 1 trial to start H2 2024
GT Biopharma, Inc.
- FDA cleared IND for GTB-3650, an NK cell engager for CD33+ leukemias; Phase 1 trial initiation expected H2 2024.
- Initial Phase 1 clinical data for GTB-3650 expected in H1 2025.
- GTB-5550 IND submission (B7H3 solid tumors) expected Q1 2025; basket trial in six solid tumor types planned for 2025.
- Company becomes fully remote effective July 1, 2024; stockholder communications to San Francisco address.
- Cash runway expected to fund operations into 2025.