Kura Oncology tanks, as FDA puts hold on KO-539 trial in AML

Shares of US biotech firm Kura Oncology (Nasdaq: KURA) slumped nearly 23% to $16.60 premarket today, after it announced that the US Food and Drug Administration has placed the KOMET-001 Phase Ib study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML) on a partial clinical hold.

The partial clinical hold was initiated following the company’s recent report to the FDA of a Grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.

Patients currently enrolled in the Phase Ib study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved. Kura is working closely with the FDA and the site investigators to resolve the partial clinical hold as quickly as possible.