Earnings summaries and quarterly performance for Kura Oncology.
Executive leadership at Kura Oncology.
Board of directors at Kura Oncology.
Research analysts who have asked questions during Kura Oncology earnings calls.
Jason Zemansky
Bank of America
4 questions for KURA
Also covers: ABOS, BBIO, CYTK +5 more
PL
Peter Lawson
Barclays PLC
4 questions for KURA
Also covers: ADAP, ARVN, BPMC +15 more
GF
George Farmer
Scotiabank
3 questions for KURA
Also covers: ABSI, ADAP, INMB +7 more
JC
Jonathan Chang
Leerink Partners
3 questions for KURA
Also covers: ADAP, GMAB, IMCR +10 more
LW
Li Wang Watsek
Cantor Fitzgerald
3 questions for KURA
Also covers: AFMD, ALXO, ARVN +7 more
JS
Jiale Song
Jefferies Financial Group Inc.
2 questions for KURA
Also covers: ACRS, CRVS, CTMX +12 more
Justin Zelin
BTIG, LLC
2 questions for KURA
Also covers: BCAB, CASI, GLMD +9 more
XD
Xiaochuan Dai
UBS
2 questions for KURA
Also covers: IMCR, NBTX, SNDX
YZ
Yue-Wen Zhu
LifeSci Capital
2 questions for KURA
Also covers: MRSN, ZYME
AH
Allen Horn
TD Cowen
1 question for KURA
BC
Bradley Canino
Stifel
1 question for KURA
Also covers: ARVN, CELC, KYMR +2 more
CZ
Charles Zhu
LifeSci Capital, LLC
1 question for KURA
Also covers: IDYA, MRSN, RVMD +2 more
Dara Azar
Stifel
1 question for KURA
Also covers: AFMD, SMMT
DD
David Dai
UBS Group AG
1 question for KURA
Also covers: IMCR, IOVA, SMMT +2 more
EH
Ellen Horste
TD Cowen
1 question for KURA
Also covers: BMRN, SNDX, TBPH
Eric Musonza
UBS
1 question for KURA
EL
Erik Lavington
Mizuho Financial Group, Inc.
1 question for KURA
ER
Ernesto Rodriguez-Dumont
TD Cowen
1 question for KURA
Also covers: DVAX, TBPH
JM
Jeet Mukherjee
Leerink Partners
1 question for KURA
Also covers: ARVN, BCAB, KYMR +4 more
PG
Peter Green
LifeSci Capital, LLC
1 question for KURA
PN
Philip Nadeau
TD Cowen
1 question for KURA
Also covers: ADVM, APLS, ATRA +13 more
RS
Roger Song
Jefferies
1 question for KURA
Also covers: AADI, AKBA, ALT +13 more
SS
Salim Syed
Mizuho Securities
1 question for KURA
Also covers: AUTL, BBIO, CYTK +5 more
YL
Yen-Der Li
Leerink Partners
1 question for KURA
Also covers: MRSN, NBTX
Recent press releases and 8-K filings for KURA.
Kura Oncology Reports Preliminary KOMZIFTI Revenue and Outlines 2026 Milestones
KURA
Product Launch
Guidance Update
New Projects/Investments
- Kura Oncology launched KOMZIFTI (ziftomenib) following its FDA approval on November 13, 2025, as the first and only once-daily, oral menin inhibitor for adults with R/R NPM1-mutated AML.
- The company reported preliminary KOMZIFTI net product revenue of $2.1 million for the period from November 21, 2025, through December 31, 2025.
- Kura Oncology received $195 million in milestone payments under a collaboration agreement and an estimated $15 million to $17 million in non-cash collaboration revenue for Q4 2025.
- As of December 31, 2025, the company held $667.3 million in cash, cash equivalents, and short-term investments. For 2026, Kura anticipates $45 million to $55 million in non-cash collaboration revenue and expects its cash position to fund the ziftomenib AML program through topline results in the front-line Phase 3 trial.
Jan 12, 2026, 11:05 AM
KURA Provides Update on Ziftomenib Combination Therapy in AML Clinical Trial
KURA
New Projects/Investments
- In newly diagnosed (ND) NPM1-m Acute Myeloid Leukemia (AML), ziftomenib 600 mg combined with Ven/Aza demonstrated 86% Composite Complete Remission (CRc) and 68% molecular CRc MRD-negativity.
- For ND NPM1-m AML patients, the median duration of CRc and median Overall Survival (OS) were not reached, indicating durable responses, and the addition of ziftomenib did not result in increased toxicity compared to Ven/Aza alone.
- In relapsed/refractory (R/R) NPM1-m AML, the combination showed 65% Overall Response Rate (ORR) and 48% CRc, with a median Duration of Response (DoR) of 39.9 weeks.
- For R/R KMT2A-r AML, the combination achieved 41% ORR and 28% CRc, with a median DoR of 12.4 weeks, and was generally well tolerated with low rates of ziftomenib-related myelosuppression.
Dec 8, 2025, 5:30 PM
Kura Oncology Provides ASH 2025 Update on Ziftomenib and Clinical Development
KURA
Product Launch
New Projects/Investments
- Kura Oncology announced the approval and availability of ziftomenib (Comzifti) as 200 mg capsules, marking its first ASH as an approved product.
- In newly diagnosed NPM1 mutant AML patients, the triplet combination of ziftomenib with azacitidine and venetoclax demonstrated high complete response (CR) rates of 73% and 68% MRD negativity, with a safety profile comparable to the aza-ven doublet.
- The combination showed impressive clinical activity in relapsed and refractory NPM1 mutant and KMT2A rearranged AML patients, particularly in those without prior venetoclax exposure, achieving a 44% CR rate in NPM1 mutant patients and 20% in KMT2A-rearranged patients in this subgroup.
- Kura Oncology is pursuing a robust clinical development plan for ziftomenib, including the registrational COMET-017 trial in newly diagnosed patients, aiming to be the first approved menin inhibitor in this setting.
- Ziftomenib's favorable safety profile and once-daily dosing were highlighted as key differentiators, with low rates of myeloid suppression, no ziftomenib-related QTc prolongation, and only one case of differentiation syndrome reported.
Dec 8, 2025, 5:30 PM
Kura Oncology Provides Ziftomenib Update at ASH 2025
KURA
Product Launch
New Projects/Investments
- Ziftomenib, branded as Komzifti, has received initial approval in the monotherapy setting.
- New data presented at ASH 2025 for ziftomenib in combination with azacitidine and venetoclax in newly diagnosed NPM1-mutated AML showed high efficacy, including a 73% complete response (CR) rate and 68% MRD negativity (at a 0.1% threshold). The median duration of complete response and median overall survival were not reached.
- The combination demonstrated a favorable safety profile, with no meaningful added toxicity or increased myeloid suppression compared to azacitidine and venetoclax alone, and limited, manageable differentiation syndrome and QTc prolongation.
- Kura Oncology plans to advance this combination to a registrational Phase 3 trial (COMET-017) in the frontline setting, aiming to be the first approved menin inhibitor in this population.
- The company highlighted differentiating safety and efficacy features of ziftomenib compared to competitor revumenib, particularly regarding lower rates of grade 3/4 neutropenia and thrombocytopenia in combination, and sustained response rates in venetoclax-exposed patients.
Dec 8, 2025, 5:30 PM
Kura Oncology Presents Positive Phase 1b Ziftomenib Triplet Therapy Data for AML
KURA
New Projects/Investments
- Kura Oncology presented positive data from the ongoing phase 1b COMET-007 trial for ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1 mutated acute myeloid leukemia (AML) patients.
- As of the September 2025 data cutoff, the trial reported a 73% complete response (CR) rate and an 86% composite CR rate among 37 efficacy-evaluable patients.
- The median duration of complete response and median overall survival were not reached, with 68% of patients alive and still on study at the time of cutoff.
- The triplet therapy demonstrated a favorable safety profile, with myeloid suppression and time to count recovery comparable to the azacitidine and venetoclax doublet.
- These results support the advancement of this combination to the registrational phase 3 COMET-017 trial.
Dec 8, 2025, 5:30 PM
Kura Oncology and Kyowa Kirin Announce Positive Combination Data for KOMZIFTI in AML
KURA
New Projects/Investments
- Kura Oncology and Kyowa Kirin reported new data from the KOMET-007 Phase 1a/1b trial for KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine for acute myeloid leukemia (AML).
- In newly diagnosed NPM1-mutated AML, the combination achieved 86% composite complete remission (CRc) and 73% complete remission (CR), with 68% of CRc responders attaining molecular MRD negativity.
- For relapsed/refractory (R/R) AML, the objective response rate (ORR) was 65% in NPM1-mutated patients and 41% in KMT2A-rearranged patients, with higher rates in venetoclax-naïve subgroups.
- The triplet combination was generally well tolerated across both newly diagnosed and R/R settings, with ziftomenib not increasing toxicity beyond venetoclax/azacitidine alone.
- KOMZIFTI is already FDA-approved and commercially available in the U.S. for adult patients with R/R AML with a susceptible NPM1 mutation.
Dec 8, 2025, 3:30 PM
Kura Oncology Announces First Commercial Sale of KOMZIFTI™ and Triggers Milestone Payment
KURA
Product Launch
Revenue Acceleration/Inflection
- Kura Oncology, Inc. announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) on December 2, 2025.
- This commercial sale triggers a $135 million payment from Kyowa Kirin to Kura Oncology, which the company expects to receive prior to year-end.
- KOMZIFTI™ was approved by the U.S. Food and Drug Administration on November 13, 2025.
Dec 2, 2025, 1:10 PM
Kura Oncology Discusses Recent FDA Approval and Market Opportunity for Zypto
KURA
Product Launch
Guidance Update
New Projects/Investments
- Kura Oncology's Zypto recently received FDA approval for relapsed/refractory (R/R) AML with NPM1 mutation.
- Zypto is positioned with safety advantages over competitors, notably a warning and precaution for QTC prolongation (mean 7.7 ms) compared to a competitor's black box warning (mean 23 ms) and a lower risk of drug-drug interactions.
- The total addressable market (TAM) for R/R NPM1 AML is estimated at $350 million to $400 million, with Kura conservatively targeting a 50% market share.
- The company anticipates top-line results from its Phase 3 trial (O17) in the significantly larger frontline AML setting in 2028, with a potential peak market opportunity of $10 billion annually.
- Kura will present ASH data on a Phase 1B study of Zypto in combination with venetoclax and enazacitidine for frontline NPM1 mutant AML, focusing on CR rate, MRD negativity, and myelosuppression.
Nov 19, 2025, 3:30 PM
Kura Oncology Discusses Recent FDA Approval and Launch of Menin Inhibitor Zypto
KURA
Product Launch
New Projects/Investments
- Kura Oncology recently received FDA approval for its menin inhibitor, Zypto, for the treatment of relapsed/refractory (R/R) AML with the NPM1 mutation.
- Zypto differentiates itself from competitors with a more favorable safety profile, specifically regarding QT prolongation (warnings and precautions vs. competitor's black box warning and risk of sudden cardiac death), no clinically meaningful drug-drug interactions with CYP3A4, and once-a-day dosing for convenience.
- The total addressable market (TAM) for Zypto in NPM1 R/R AML is estimated at $350 million to $400 million, with Kura conservatively assuming a 50% market share.
- The frontline AML market represents a significantly larger opportunity, estimated to be 10 to 20 times larger than the R/R market, with a potential peak of $10 billion annually for 10,000 to 12,000 patients a year at 12 to 24 months.
- Kura anticipates presenting two oral presentations at ASH, including data from their ongoing Phase 1B trial of Zypto in combination with venetoclax and enasidenib (Veneza) for frontline NPM1 mutant AML, focusing on CR rate, MRD negativity, and safety.
Nov 19, 2025, 3:30 PM
Kura Oncology Discusses Ziftomenib FDA Approval and Market Opportunity
KURA
Product Launch
Guidance Update
New Projects/Investments
- Kura Oncology's drug, ziftomenib, has received FDA approval for relapsed/refractory (R/R) AML with NPM1 mutation.
- The company estimates the total addressable market (TAM) for NPM1 R/R AML at $350 million-$400 million, with a conservative assumption of 50% market share.
- Ziftomenib is positioned with a favorable safety profile regarding QT prolongation (warning and precaution for 7.7 ms mean elongation vs. a competitor's black box warning for 23 ms mean elongation) and lack of clinically meaningful drug-drug interactions.
- Kura anticipates top-line results from its phase III trial in the frontline setting by 2028, targeting an opportunity estimated to be 10 to 20 times larger than the R/R market, potentially reaching $10 billion annually at peak.
Nov 19, 2025, 3:30 PM
Quarterly earnings call transcripts for Kura Oncology.
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