regulatory
confidence high
sentiment negative
materiality 0.80
Graphite Bio pauses Phase 1/2 sickle cell gene therapy study after serious adverse event in first patient
LENZ Therapeutics, Inc.
- First patient dosed with nula-cel experienced prolonged pancytopenia requiring ongoing transfusion and growth factor support.
- Company will not meet guidance for initial proof-of-concept data in mid-2023; IND for GPH102 in beta-thalassemia delayed beyond mid-2024.
- Company working to identify operational efficiencies to extend cash runway to at least 2026; will provide business update by end of Q1 2023.
- Patient achieved neutrophil engraftment with no evidence of myelodysplasia; event reported to FDA.