Kura Oncology, Inc. (KURA) Discusses Ziftomenib Combination Data in Newly Diagnosed and Relapsed/Refractory NPM1-m and KMT2A-r AML Transcript

Kura Oncology, Inc. (KURA) Discusses Ziftomenib Combination Data in Newly Diagnosed and Relapsed/Refractory NPM1-m and KMT2A-r AML Transcript

Seeking Alpha • Dec 8, 2025

Kura Oncology and Kyowa Kirin Report Combination Data for KOMZIFTI™ (Ziftomenib) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory AML

– 86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS  – Median duration of complete response and overall survival not yet reached in newly diagnosed NPM1-m patients as of data cutoff – – 65% (31/48) ORR in R/R NPM1-m AML, 83% (19/23) ORR in venetoclax-naïve – – 41% (13/32) ORR in R/R KMT2A-r AML, 70% (7/10) ORR in venetoclax-naïve – – Triplet combination was well tolerated in both newly diagnosed and relapsed/refractory settings; addition of ziftomenib did not increase toxicity beyond that expected with venetoclax/azacitidine alone – – Ziftomenib's broad clinical development program spans multiple front-line and relapsed/refractory regimens across NPM1-m, FLT3-m and KMT2A-r AML subtypes – – Company-sponsored registrational trials of ziftomenib in front-line AML are ongoing in both intensive chemotherapy-eligible and -ineligible patients – – Kura Oncology to host a virtual investor event today, December 8, 2025, at 12:30 p.m. ET  /  9:30 a.m.

GlobeNewsWire • Dec 8, 2025

Kura Oncology: A Cautious Buy

Kura Oncology (KURA) is rated a cautious Speculative Buy, driven by Komzifti's FDA approval and frontline AML potential. KURA's near-term revenue under the current label is meaningful but insufficient to justify its full market cap; upside hinges on frontline expansion. Komzifti's superior cardiac safety profile positions KURA to compete aggressively in the larger NPM1-mutated AML market via combination therapies.

Seeking Alpha • Dec 4, 2025

Kura Oncology to Host Virtual Investor Event to Discuss Data Presented at ASH 2025 on Triplet Combination of Ziftomenib (KOMZIFTI®) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia

SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that it will be hosting a virtual analyst and investor event on Monday, December 8, 2025, at 12:30 PM ET / 9:30 AM PT, to discuss data on the triplet combination of ziftomenib (KOMZIFTI®) with venetoclax and azacitidine in newly diagnosed and relapsed/refractory acute myeloid leukemia scheduled for presentation at the 67th American Society of Hematology (ASH) Annual Meeting. The virtual event will feature members of the management team alongside lead investigators.

GlobeNewsWire • Dec 3, 2025

First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin

SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) has been completed. Under Kura's collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa Kirin, Inc. (collectively, “Kyowa Kirin”), this milestone triggers a $135 million payment from Kyowa Kirin to Kura, which Kura expects to receive prior to year-end. KOMZIFTI was approved by the U.S. Food and Drug Administration on November 13, 2025.

GlobeNewsWire • Dec 2, 2025

Kura Oncology: Expect Volatility Following Ziftomenib Phase 1b Data

Kura Oncology remains a Strong Buy, driven by Ziftomenib's differentiated safety profile and significant AML market potential. KURA's Ziftomenib avoids a QTc prolongation boxed warning, offering a potential safety edge over Syndax's Revuforj despite similar efficacy in R/R NPM1-mutated AML. Upcoming Phase 1b KOMET-007 data at ASH could shift market sentiment, with volatility expected as efficacy is compared to Syndax's robust results.

Seeking Alpha • Dec 2, 2025

KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)

KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States

GlobeNewsWire • Nov 25, 2025

Kura Oncology, Inc. (KURA) Discusses FDA Approval of KOMZIFTI for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia Transcript

Kura Oncology, Inc. ( KURA ) Discusses FDA Approval of KOMZIFTI for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia November 13, 2025 12:30 PM EST Company Participants Greg Mann Troy Wilson - Chairman, CEO & President Mollie Leoni - Chief Medical Officer Brian Powl - Chief Commercial Officer Conference Call Participants Eunice Wang Daniel Bronder Jonathan Chang - Leerink Partners LLC, Research Division Reni Benjamin - Citizens JMP Securities, LLC, Research Division Yue-Wen Zhu - LifeSci Capital, LLC, Research Division Erik Lavington - Mizuho Securities USA LLC, Research Division Jiale Song - Jefferies LLC, Research Division Bradley Canino - Guggenheim Securities, LLC, Research Division Philip Nadeau - TD Cowen, Research Division Jason Zemansky - BofA Securities, Research Division Etzer Darout - Barclays Bank PLC, Research Division Xiaochuan Dai - UBS Investment Bank, Research Division Presentation Operator At this time, I would like to welcome you to the Kura Oncology FDA approval conference call. [Operator Instructions] At this time, I would like to turn the call over to Greg Mann from Kura Oncology.

Seeking Alpha • Nov 19, 2025

US FDA approves Kura Oncology's blood cancer therapy

The U.S. Food and Drug Administration has approved Kura Oncology's drug to treat a rare form of blood cancer that has returned or resisted initial therapy, the regulator said on Thursday.

Reuters • Nov 13, 2025

Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medications in adult patients with R/R NPM1-mutated AML – – KOMZIFTI approval granted with no Boxed Warning related to QTc prolongation or Torsades de Pointes – – Kura Oncology will host a conference call on November 13, 2025, at 12:30 pm ET / 9:30 am PT – SAN DIEGO and TOYKO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

GlobeNewsWire • Nov 13, 2025