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[8-K] Kura Oncology, Inc. Reports Material Event

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Kura Oncology announced receipt of a $30 million milestone payment from Kyowa Kirin. The payment was triggered by dosing the first patient in KOMET-017, a pair of Phase 3 registrational trials evaluating ziftomenib, a once-daily, investigational oral menin inhibitor.

KOMET-017 consists of two independent, global, randomized double-blind, placebo-controlled Phase 3 studies. They assess ziftomenib in combination with intensive and non‑intensive chemotherapy in adults with newly diagnosed NPM1‑mutated or KMT2A‑rearranged acute myeloid leukemia. The payment provides non-dilutive funding aligned with the advancement of ziftomenib into late‑stage testing.

Kura Oncology ha annunciato di aver ricevuto un pagamento milestone di $30 million da Kyowa Kirin. Il pagamento è stato attivato dalla somministrazione al primo paziente nello studio KOMET-017, una coppia di trial registrazionali di fase 3 randomizzati in doppio cieco, controllati con placebo, che valutano ziftomenib, un inibitore della menina sperimentale assunto una volta al giorno.

KOMET-017 consiste in due studi indipendenti, globali, randomizzati in doppio cieco, controllati con placebo di fase 3. Valutano ziftomenib in combinazione con chemioterapia intensiva e non intensiva in adulti con leucemia mieloide acuta recentemente diagnosticata con NPM1‑mutated o KMT2A‑rearranged. Il pagamento fornisce finanziamento non diluitivo allineato all'avanzamento di ziftomenib verso test di fase avanzata.

Kura Oncology anunció haber recibido un pago por hito de $30 millones por parte de Kyowa Kirin. El pago se activó al administrar el primer paciente en KOMET-017, una pareja de ensayos de fase 3, aleatorizados, multi‑centro, doble ciego y con placebo, que evalúan ziftomenib, un inhibidor de la menina oral, investigacional, tomado una vez al día.

KOMET-017 consta de dos estudios independientes, globales, aleatorizados, dobles ciegos y controlados con placebo de fase 3. Evaluan ziftomenib en combinación con quimioterapia intensiva y no intensiva en adultos con leucemia mieloide aguda diagnosticada recientemente con NPM1‑mutated o KMT2A‑rearranged. El pago ofrece financiamiento no diluyente alineado con el avance de ziftomenib hacia pruebas en fases avanzadas.

Kura OncologyKyowa Kirin으로부터 $30 million의 마일스톤 지급을 수령했다고 발표했습니다. 이 지급은 KOMET-017의 첫 환자 투여로 촉발되었으며, ziftomenib를 평가하는 두 건의 3상 등록 무작위 더블블라인드, 위약 대조 임상으로 구성된 다중 글로벌 연구입니다. ziftomenib는 하루에 한 번 투여하는 실험적 직접 멘인 억제제입니다.

KOMET-017은 두 개의 독립적이고 전 세계적인 3상 연구로 구성되어 있으며, 무작위, 이중 맹검, 위약 대조를 통해 평가됩니다. 성인에서 새로 진단된 NPM1‑mutated 또는 KMT2A‑rearranged 급성 골수성 백혈병 환자에서 고강도 및 비고강도 화학요법과의 병용 치료를 평가합니다. 이 지급은 ziftomenib를 후기 단계의 시험으로 진전시키는 데 비희석식 자금을 제공합니다.

Kura Oncology a annoncé avoir reçu un paiement d’étape de $30 millions de la part de Kyowa Kirin. Le paiement a été déclenché par l’administration du premier patient dans KOMET-017, une paire d’essais de phase 3, randomisés, en double aveugle et contrôlés par placebo, évaluant ziftomenib, un inhibiteur de la menine expérimental administré une fois par jour.

KOMET-017 se compose de deux études indépendantes, mondiales, randomisées, en double aveugle et contrôlées par placebo de phase 3. Elles évaluent ziftomenib en association avec une chimiothérapie intensive et non intensive chez des adultes atteints de leucémie myéloïde aiguë récemment diagnostiquée présentant une mutations NPM1 ou des riarrangements KMT2A. Le paiement fournit un financement non dilutif aligné sur l’avancement de ziftomenib vers des essais en stade avancé.

Kura Oncology hat bekannt gegeben, dass ein Meilensteinzahlung von $30 million von Kyowa Kirin eingegangen ist. Die Zahlung wurde durch die Verabreichung des ersten Patienten in KOMET-017 ausgelöst, einem Paar von Phase-3-Registrationsstudien, die ziftomenib bewerten, einem einstündigen, oralen Menin-Inhibitoren-Inhibitor, der einmal täglich eingenommen wird.

KOMET-017 besteht aus zwei unabhängigen, globalen, randomisierten, doppelblinden, placebokontrollierten Phase-3-Studien. Sie bewerten ziftomenib in Kombination mit intensiver und nicht-intensiver Chemotherapie bei Erwachsenen mit neu diagnostizierter NPM1‑mutated oder KMT2A‑rearranged akuter myeloischer Leukämie. Die Zahlung bietet nicht dilutive Finanzierung, die mit dem Fortschritt von ziftomenib in späte Phase-Tests übereinstimmt.

Kura Oncology أعلنت عن استلام دفعة معلم خطوة قدرها $30 مليون من Kyowa Kirin. تم تحفيز الدفع بإعطاء الدواء لأول مريض في KOMET-017، وهي زوج من التجارب من المرحلة 3 العشوائية المزدوجة التعمية والسيطرة بالدواء الوهمي التي تقيم ziftomenib، وهو مثبط مينين فموي investigational يؤخذ مرة يوميًا.

KOMET-017 يتكون من دراستين مستقلتين وعالميتين ومُتَعارضتين عشوائيًا ومُعْتلَتَين ومُتَحكَّمتين بالدواء الوهمي من المرحلة 3. تقيم ziftomenib بالاشتراك مع العلاج الكيميائي المكثف وغير المكثف في بالغين مصابين بسرطان الدم اللمفاوي الحاد بنمط NPM1‑mutated أو KMT2A‑rearranged. يوفر الدفع تمويلاً غير مخفِّض يتماشى مع تقدم ziftomenib إلى اختبارات المرحلة المتقدمة.

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Insights

$30M milestone received as Phase 3 dosing begins; cash-in, clinical risk persists.

The collaboration with Kyowa Kirin includes milestone payments tied to development events. First patient dosing in the Phase 3 KOMET-017 program activated a $30 million payment to Kura Oncology, adding non-dilutive cash as ziftomenib advances.

KOMET-017 comprises two global, randomized, double-blind, placebo-controlled trials testing ziftomenib with intensive and non‑intensive chemotherapy in newly diagnosed NPM1‑mutated or KMT2A‑rearranged AML. While the cash inflow is clear, outcomes and regulatory paths remain dependent on Phase 3 results.

The immediate, tangible effect is the milestone receipt; subsequent impact depends on trial conduct and readouts, which are not detailed in the excerpt.

Kura Oncology ha annunciato di aver ricevuto un pagamento milestone di $30 million da Kyowa Kirin. Il pagamento è stato attivato dalla somministrazione al primo paziente nello studio KOMET-017, una coppia di trial registrazionali di fase 3 randomizzati in doppio cieco, controllati con placebo, che valutano ziftomenib, un inibitore della menina sperimentale assunto una volta al giorno.

KOMET-017 consiste in due studi indipendenti, globali, randomizzati in doppio cieco, controllati con placebo di fase 3. Valutano ziftomenib in combinazione con chemioterapia intensiva e non intensiva in adulti con leucemia mieloide acuta recentemente diagnosticata con NPM1‑mutated o KMT2A‑rearranged. Il pagamento fornisce finanziamento non diluitivo allineato all'avanzamento di ziftomenib verso test di fase avanzata.

Kura Oncology anunció haber recibido un pago por hito de $30 millones por parte de Kyowa Kirin. El pago se activó al administrar el primer paciente en KOMET-017, una pareja de ensayos de fase 3, aleatorizados, multi‑centro, doble ciego y con placebo, que evalúan ziftomenib, un inhibidor de la menina oral, investigacional, tomado una vez al día.

KOMET-017 consta de dos estudios independientes, globales, aleatorizados, dobles ciegos y controlados con placebo de fase 3. Evaluan ziftomenib en combinación con quimioterapia intensiva y no intensiva en adultos con leucemia mieloide aguda diagnosticada recientemente con NPM1‑mutated o KMT2A‑rearranged. El pago ofrece financiamiento no diluyente alineado con el avance de ziftomenib hacia pruebas en fases avanzadas.

Kura OncologyKyowa Kirin으로부터 $30 million의 마일스톤 지급을 수령했다고 발표했습니다. 이 지급은 KOMET-017의 첫 환자 투여로 촉발되었으며, ziftomenib를 평가하는 두 건의 3상 등록 무작위 더블블라인드, 위약 대조 임상으로 구성된 다중 글로벌 연구입니다. ziftomenib는 하루에 한 번 투여하는 실험적 직접 멘인 억제제입니다.

KOMET-017은 두 개의 독립적이고 전 세계적인 3상 연구로 구성되어 있으며, 무작위, 이중 맹검, 위약 대조를 통해 평가됩니다. 성인에서 새로 진단된 NPM1‑mutated 또는 KMT2A‑rearranged 급성 골수성 백혈병 환자에서 고강도 및 비고강도 화학요법과의 병용 치료를 평가합니다. 이 지급은 ziftomenib를 후기 단계의 시험으로 진전시키는 데 비희석식 자금을 제공합니다.

Kura Oncology a annoncé avoir reçu un paiement d’étape de $30 millions de la part de Kyowa Kirin. Le paiement a été déclenché par l’administration du premier patient dans KOMET-017, une paire d’essais de phase 3, randomisés, en double aveugle et contrôlés par placebo, évaluant ziftomenib, un inhibiteur de la menine expérimental administré une fois par jour.

KOMET-017 se compose de deux études indépendantes, mondiales, randomisées, en double aveugle et contrôlées par placebo de phase 3. Elles évaluent ziftomenib en association avec une chimiothérapie intensive et non intensive chez des adultes atteints de leucémie myéloïde aiguë récemment diagnostiquée présentant une mutations NPM1 ou des riarrangements KMT2A. Le paiement fournit un financement non dilutif aligné sur l’avancement de ziftomenib vers des essais en stade avancé.

Kura Oncology hat bekannt gegeben, dass ein Meilensteinzahlung von $30 million von Kyowa Kirin eingegangen ist. Die Zahlung wurde durch die Verabreichung des ersten Patienten in KOMET-017 ausgelöst, einem Paar von Phase-3-Registrationsstudien, die ziftomenib bewerten, einem einstündigen, oralen Menin-Inhibitoren-Inhibitor, der einmal täglich eingenommen wird.

KOMET-017 besteht aus zwei unabhängigen, globalen, randomisierten, doppelblinden, placebokontrollierten Phase-3-Studien. Sie bewerten ziftomenib in Kombination mit intensiver und nicht-intensiver Chemotherapie bei Erwachsenen mit neu diagnostizierter NPM1‑mutated oder KMT2A‑rearranged akuter myeloischer Leukämie. Die Zahlung bietet nicht dilutive Finanzierung, die mit dem Fortschritt von ziftomenib in späte Phase-Tests übereinstimmt.

Kura Oncology أعلنت عن استلام دفعة معلم خطوة قدرها $30 مليون من Kyowa Kirin. تم تحفيز الدفع بإعطاء الدواء لأول مريض في KOMET-017، وهي زوج من التجارب من المرحلة 3 العشوائية المزدوجة التعمية والسيطرة بالدواء الوهمي التي تقيم ziftomenib، وهو مثبط مينين فموي investigational يؤخذ مرة يوميًا.

KOMET-017 يتكون من دراستين مستقلتين وعالميتين ومُتَعارضتين عشوائيًا ومُعْتلَتَين ومُتَحكَّمتين بالدواء الوهمي من المرحلة 3. تقيم ziftomenib بالاشتراك مع العلاج الكيميائي المكثف وغير المكثف في بالغين مصابين بسرطان الدم اللمفاوي الحاد بنمط NPM1‑mutated أو KMT2A‑rearranged. يوفر الدفع تمويلاً غير مخفِّض يتماشى مع تقدم ziftomenib إلى اختبارات المرحلة المتقدمة.

Kura Oncology宣布已从 Kyowa Kirin 收到一笔额外里程碑付款,金额为 $30 million。此付款由在 KOMET-017 首位患者给药触发,该研究是一对评估每日至少一次口服、在研的 ziftomenib 的三期注册性试验。

KOMET-017 由两项独立的全球性、随机、双盲、安慰剂对照的三期研究组成。它们评估 ziftomenib 与强化化疗和非强化化疗联合治疗新诊断的成人 NPM1‑mutatedKMT2A‑rearranged 急性髓系白血病患者的疗效。该付款提供与将 ziftomenib 推进至晚期阶段测试相一致的非稀释性资助。

false 0001422143 0001422143 2025-10-24 2025-10-24
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 24, 2025

 

 

KURA ONCOLOGY, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-37620   61-1547851

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

4930 Directors Place, Suite 500, San Diego, CA   92121
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 500-8800

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, par value $0.0001 per share   KURA   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 8.01

Other Events.

On October 24, 2025, Kura Oncology, Inc. (the “Company”) announced receipt of a $30 million milestone payment under its Collaboration and License Agreement with Kyowa Kirin, Inc. and Kyowa Kirin Co., Ltd. (together,“Kyowa Kirin”) in connection with the dosing of the first patient in the KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. The Company and Kyowa Kirin announced the launch of the KOMET-017 trials on September 29, 2025.

KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Kura Oncology, Inc.
Date: October 24, 2025     By:  

/s/ Teresa Bair

      Teresa Bair
      Chief Legal Officer

FAQ

What did Kura Oncology (KURA) announce in this update?

Kura Oncology announced receipt of a $30 million milestone payment from Kyowa Kirin.

What triggered the $30 million payment to KURA?

Dosing of the first patient in the Phase 3 registrational KOMET-017 trials of ziftomenib.

What is being studied in KOMET-017?

Ziftomenib, an investigational once‑daily oral menin inhibitor, combined with intensive and non‑intensive chemotherapy in newly diagnosed NPM1‑mutated or KMT2A‑rearranged AML.

How many Phase 3 studies are in KOMET-017?

Two independent, global, randomized, double‑blind, placebo‑controlled trials.

Who is Kura Oncology’s partner on ziftomenib?

Kyowa Kirin, Inc. and Kyowa Kirin Co., Ltd.

When was KOMET-017 launched?

Kura Oncology and Kyowa Kirin announced the launch on September 29, 2025.
Kura Oncology Inc

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