During the current market session, Kura Oncology, Inc. (NASDAQ: KURA) is observing a significant upsurge in its stock, demonstrating a notable escalation of 8.53% to $19.02. This positive movement in KURA shares can be attributed to the recent strides made by the company in the realm of novel drug development.
Today, Kura Oncology (KURA) has officially declared that its investigational drug, ziftomenib, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA). This designation has been granted for the treatment of patients grappling with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML).
In patients with R/R NPM1-mutant AML, the FDA granted BTD based on Kura’s KOMET-001 clinical research. BTD is accorded to drugs that target serious or life-threatening conditions and for which preliminary clinical evidence suggests a potential for substantial improvement over existing therapies on clinically significant endpoints.
This designation is geared towards expediting the development and evaluation of drugs, entailing a dedicated commitment from FDA senior management and seasoned review personnel, alongside eligibility for rolling review and priority review. The FDA’s decision underscores the promising potential of the drug as an innovative therapeutic solution for patients grappling with relapsed/refractory NPM1-mutant AML.
NPM1-mutant AML accounts for approximately 30% of new AML cases annually. The awarding of this designation underscores the substantial unmet need in treating NPM1-mutant AML, where no targeted therapy has been approved to date, while highlighting the potential of ziftomenib to offer considerable improvement over existing treatment modalities.
Remaining steadfast in its commitment, Kura Oncology is dedicated to expediting the availability of ziftomenib to the market, catering to the urgent requirements of patients in need of effective treatments. The company is poised to conclude the registration-directed trial of ziftomenib in R/R NPM1-mutant AML by mid-2024.
Furthermore, ziftomenib is undergoing evaluation in conjunction with current standard treatments, such as venetoclax/azacitidine or cytarabine plus daunorubicin in NPM1-mutant and KMT2A-rearranged AML (KOMET-007), and with gilteritinib, FLAG-IDA, or LDAC in NPM1-mutant and KMT2A-rearranged AML (KOMET-008).
