Kura Oncology Drug Added to Key US Cancer Guidelines
KOMZIFTI's inclusion in the influential NCCN guidelines for AML is expected to accelerate commercial adoption following its recent FDA approval.
Kura Oncology, Inc. (NASDAQ: KURA) secured a critical commercial catalyst on Tuesday after its recently approved cancer therapy, KOMZIFTI™ (ziftomenib), was added to the influential National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (AML).
The inclusion comes less than two weeks after the drug received full FDA approval on November 13, 2025, and is a significant step in establishing KOMZIFTI as a standard of care for a specific group of high-risk patients. The NCCN, an alliance of leading cancer centers, publishes guidelines that are considered the benchmark for clinical direction and policy in oncology, heavily influencing treatment decisions by physicians and reimbursement policies by payers.
KOMZIFTI has been included as a Category 2A recommended treatment for adults with relapsed or refractory AML who have a susceptible NPM1 mutation. This genetic marker is one of the most common mutations in AML, and patients who relapse have historically faced grim prognoses.
Shares of Kura Oncology traded near their 52-week high of $12.49 in Tuesday's session. The company, based in San Diego, now has a market capitalization exceeding $1 billion, reflecting growing investor optimism around its commercial trajectory.
"The addition of KOMZIFTI to the NCCN Guidelines® in Oncology underscores the potential impact of KOMZIFTI for patients with R/R NPM1-mutated AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology, in a statement released Tuesday. "We are pleased to have received inclusion in the NCCN guidelines so rapidly after FDA approval and are committed to making KOMZIFTI available to patients in the United States."
The drug is the first and only once-daily oral menin inhibitor approved for this patient population. Its approval was based on the KOMET-001 clinical trial, which demonstrated a complete remission rate of 21.4% and a median duration of response of five months. This novel mechanism of action targets a key protein dependency in this form of leukemia, representing a new therapeutic approach.
The rapid NCCN guideline inclusion provides Kura with a powerful tool for its commercial launch, potentially accelerating its uptake in a competitive market. Analysts have been broadly positive on the drug's prospects, with several firms reiterating "Buy" and "Outperform" ratings in October. HC Wainwright & Co. set a price target of $40, anticipating blockbuster potential and citing a favorable safety profile compared to competitors.
With KOMZIFTI now commercially available in the U.S. through a network of specialty pharmacies, Kura Oncology is focused on execution. The company is also developing the drug for front-line treatment of AML, signaling a broader ambition to move the therapy into earlier lines of treatment and expand its market opportunity.