Biotech Values

[DewDiligence]

GRPH—(-51%/AH)—halts phase-1/2 in SCD after SAE observed in first patient:

https://finance.yahoo.com/news/graphite-bio-announces-voluntary-pause-210500231.html

Graphite Bio, Inc…today announced it is voluntarily pausing the Phase 1/2 CEDAR study of nulabeglogene autogedtemcel (nula-cel) for sickle cell disease (SCD) due to a serious adverse event in the first patient dosed with nula-cel, and the company’s conclusion that the event is likely related to study treatment.

As a result, the company will not meet its guidance for initial proof-of-concept data in mid-2023.

The decision by Graphite Bio to voluntarily pause the CEDAR study follows a serious and unexpected adverse event of prolonged low blood cell counts (pancytopenia) requiring ongoing transfusion and growth factor support in the first patient dosed with nula-cel.

,,,Graphite Bio is comprehensively assessing the adverse event, risk factors and mitigation strategies, including potential modifications to the nula-cel manufacturing process. The clinical investigators and Safety Monitoring Committee for the CEDAR study have agreed with the company’s decision to suspend dosing of additional patients pending this assessment.

Ouch.

As I’m typing, the stock is down 91% from its mid-2021 IPO (#msg-164592161).