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    <title>Kyowa Kirin Co., Ltd. — News on 6ix</title>
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    <description>Latest news and press releases for Kyowa Kirin Co., Ltd. on 6ix.</description>
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      <title>Kyowa Kirin Co., Ltd.</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd</link>
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    <item>
      <title>Kyowa Kirin and Kura Oncology Initiate Japanese Phase 2 Registration-Directed Trial of Ziftomenib in R/R NPM1-m AML</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-and-kura-oncology-initiate-japanese-phase-2-registration-directed-trial-of-ziftomenib-in-rr-npm1-m-aml</link>
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      <pubDate>Fri, 24 Apr 2026 12:00:00 GMT</pubDate>
      <description>– Regulatory Filing in Japan Planned Following Clinical Trial Completion –TOKYO and SAN DIEGO, April 24, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) and Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) today announced the first patient has been dosed in a Japanese Phase 2 registrational clinical trial (jRCT2031250550) studying ziftomenib, an oral menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML). NPM1-m A</description>
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      <title>Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-to-regain-control-of-rocatinlimab-development-and-commercialization-program-demonstrating-strong-commitment-to-address-high-unmet-medical-need-in-atopic-dermatitis</link>
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      <pubDate>Fri, 30 Jan 2026 13:00:00 GMT</pubDate>
      <description>Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential.Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD).Regulatory submission is planned in the first half of 2026. TOKYO and PRINCETON, N.J., Jan. 30, 2026 (GLOB</description>
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      <title>Kura Oncology and Kyowa Kirin Report Combination Data for KOMZIFTI™ (Ziftomenib) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory AML</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-report-combination-data-for-komziftitm-ziftomenib-with-venetoclax-and-azacitidine-in-newly-diagnosed-and-relapsedrefractory-aml</link>
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      <pubDate>Mon, 08 Dec 2025 15:30:00 GMT</pubDate>
      <description>– 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 a</description>
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      <title>First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/first-us-commercial-sale-of-komziftitm-triggers-dollar135-million-milestone-payment-to-kura-oncology-under-collaboration-and-license-agreement-with-kyowa-kirin</link>
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      <pubDate>Tue, 02 Dec 2025 13:02:00 GMT</pubDate>
      <description>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, wh</description>
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      <title>KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/komziftitm-ziftomenib-added-to-national-comprehensive-cancer-networkr-nccn-guidelines-for-acute-myeloid-leukemia-aml</link>
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      <pubDate>Tue, 25 Nov 2025 22:16:00 GMT</pubDate>
      <description>KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United StatesSAN DIEGO and TOKYO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced KOMZIFTI™ (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutati</description>
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      <title>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</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-announce-fda-approval-of-komziftitm-ziftomenib-the-first-and-only-once-daily-targeted-therapy-for-adults-with-relapsed-or-refractory-npm1-mutated-acute-myeloid-leukemia</link>
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      <pubDate>Thu, 13 Nov 2025 15:51:00 GMT</pubDate>
      <description>– 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 suppo</description>
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      <title>Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-receives-second-dollar30-million-development-milestone-payment-in-aml-menin-inhibitor-program-with-kyowa-kirin</link>
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      <pubDate>Mon, 03 Nov 2025 21:02:00 GMT</pubDate>
      <description>– Milestone triggered by dosing of first patient in the second of two frontline AML Phase 3 clinical trials –SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the second of tw</description>
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      <title>Kura Oncology and Kyowa Kirin Announce Presentations of Ziftomenib Ven/Aza Combination Data in Frontline and Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia at 2025 ASH Annual Meeting</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-announce-presentations-of-ziftomenib-venaza-combination-data-in-frontline-and-relapsedrefractory-npm1-m-or-kmt2a-r-acute-myeloid-leukemia-at-2025-ash-annual-meeting</link>
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      <pubDate>Mon, 03 Nov 2025 14:14:00 GMT</pubDate>
      <description>– Data to be featured in two oral presentations on December 8, 2025 – – Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use – SAN DIEGO and TOKYO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured i</description>
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    <item>
      <title>Boehringer Ingelheim acquires license from Kyowa Kirin aimed at developing a novel treatment for patients with autoimmune diseases</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/boehringer-ingelheim-acquires-license-from-kyowa-kirin-aimed-at-developing-a-novel-treatment-for-patients-with-autoimmune-diseases</link>
      <guid isPermaLink="true">https://6ix.com/company/kyowa-kirin-co-ltd/news/boehringer-ingelheim-acquires-license-from-kyowa-kirin-aimed-at-developing-a-novel-treatment-for-patients-with-autoimmune-diseases</guid>
      <pubDate>Thu, 30 Oct 2025 06:40:00 GMT</pubDate>
      <description>Logo_Kyowa Logo_KyowaKirin The licensed small molecule program aims to address significant unmet needs for autoimmune diseases. Program adds to Boehringer’s pipeline and its commitment to deliver breakthrough therapies for patients with inflammatory diseases. Ingelheim, Germany, and Tokyo, Japan, [October 30, 2025] – Boehringer Ingelheim and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and COO: Abdul Mullick) today announced that Boehringer Ingelheim has licensed a pre-clinical progra</description>
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      <title>Kyowa Kirin and Orchard Therapeutics Announce  OTL-200 Granted Orphan Regenerative Medicine Product Designation for Early-onset MLD in Japan</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-and-orchard-therapeutics-announce-otl-200-granted-orphan-regenerative-medicine-product-designation-for-early-onset-mld-in-japan</link>
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      <pubDate>Tue, 28 Oct 2025 06:00:00 GMT</pubDate>
      <description>– First and only disease-modifying therapy for the treatment of eligible children with MLD also receives Orphan Drug Designation and Priority Review in the Kingdom of Saudi Arabia –TOKYO, LONDON and BOSTON, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd., (TSE: 4151, President and COO: Abdul Mullick, &quot;Kyowa Kirin&quot;) and Orchard Therapeutics announced that Japan&apos;s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Regenerative Medicine Product Designation to OTL-200, also know</description>
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      <title>Kura Oncology Receives $30 Million Development Milestone Payment in Ziftomenib AML Program with Kyowa Kirin</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-receives-dollar30-million-development-milestone-payment-in-ziftomenib-aml-program-with-kyowa-kirin</link>
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      <pubDate>Fri, 24 Oct 2025 11:02:00 GMT</pubDate>
      <description>- Milestone triggered by dosing of first patient in frontline AML Phase 3 clinical program- SAN DIEGO, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the KOMET-017 Phase 3 registratio</description>
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      <title>Menin Inhibitors Drug Market Report 2025: Price, Sales &amp; Clinical Trials Insights 2024-2028 - Kura Oncology &amp; Kyowa Kirin Progress with New Drug Applications</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/menin-inhibitors-drug-market-report-2025-price-sales-and-clinical-trials-insights-2024-2028-kura-oncology-and-kyowa-kirin-progress-with-new-drug-applications</link>
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      <pubDate>Fri, 10 Oct 2025 08:54:00 GMT</pubDate>
      <description>Market opportunities for menin inhibitors include addressing unmet needs in high-risk acute leukemias, exploring indications beyond AML to solid tumors and diabetes, leveraging next-gen design for improved safety, and expanding market access through global partnerships and collaborations.Dublin, Oct. 10, 2025 (GLOBE NEWSWIRE) -- The &quot;Menin Inhibitors Drug Market, Price, Sales &amp; Clinical Trials Insight 2028&quot; report has been added to ResearchAndMarkets.com&apos;s offering.Report Findings &amp; Highlights:</description>
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      <title>Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-launch-clinical-trial-evaluating-dual-inhibition-of-npm1-and-flt3-mutations-in-patients-with-newly-diagnosed-acute-myeloid-leukemia-aml</link>
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      <pubDate>Wed, 01 Oct 2025 11:01:00 GMT</pubDate>
      <description>– Expanding clinical experience and safety profile of ziftomenib support its evaluation in combination with approved FLT3 inhibitors in frontline AML – – FLT3 mutations occur in approximately 30% of newly diagnosed adult patients with AML and up to 50% of adult patients with NPM1-m AML, making FLT3 one of the most common genetic alterations in AML – – Ziftomenib clinical trials are now active in multiple frontline settings that include up to 50% of incident patients with AML in the U.S. – SAN DI</description>
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      <title>Kura Oncology and Kyowa Kirin Announce First Patient Dosed in Pivotal Phase 3 KOMET-017 Trial of Ziftomenib for Frontline Acute Myeloid Leukemia (AML)</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-announce-first-patient-dosed-in-pivotal-phase-3-komet-017-trial-of-ziftomenib-for-frontline-acute-myeloid-leukemia-aml</link>
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      <pubDate>Mon, 29 Sep 2025 20:01:00 GMT</pubDate>
      <description>– KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated and full approval – – KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated and full approval – SAN DIEGO and TOKYO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today ann</description>
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      <title>Kura Oncology and Kyowa Kirin Announce Publication of Pivotal Ziftomenib Data in Relapsed/Refractory NPM1-Mutated AML in the Journal of Clinical Oncology</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-announce-publication-of-pivotal-ziftomenib-data-in-relapsedrefractory-npm1-mutated-aml-in-the-journal-of-clinical-oncology</link>
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      <pubDate>Thu, 25 Sep 2025 21:18:00 GMT</pubDate>
      <description>– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses – – Consistent activity across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, lines of therapy, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile, including a lack of clinically significant QTc prolongation or myelosuppression – – Prescription Drug User Fee Act (PDUFA) target action date for FDA Priority Review</description>
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      <title>Kyowa Kirin Announces Late-Breaking Abstract Presentation  at the European Academy of Dermatology and Venerology Congress</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-announces-late-breaking-abstract-presentation-at-the-european-academy-of-dermatology-and-venerology-congress</link>
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      <pubDate>Thu, 11 Sep 2025 12:00:00 GMT</pubDate>
      <description>Princeton, NJ and TOKYO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET-SHUTTLE trial of rocatinlimab, an investigational T-cell rebalancing therapy, will be presented as a late breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025. This trial assessed the efficacy and safety of rocatinlimab every 4 weeks in combinat</description>
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      <title>Amgen and Kyowa Kirin Announce Top-Line Results From Rocatinlimab Phase 3 ASCEND Long-Term Extension Study in Adults With Moderate to Severe Atopic Dermatitis</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis</link>
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      <pubDate>Tue, 09 Sep 2025 04:12:00 GMT</pubDate>
      <description>THOUSAND OAKS, Calif. and TOKYO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate the long-term safety and efficacy of ro</description>
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      <title>Kyowa Kirin Premiers New CTCL Staging Tool for Healthcare Providers</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-premiers-new-ctcl-staging-tool-for-healthcare-providers</link>
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      <pubDate>Tue, 19 Aug 2025 13:01:00 GMT</pubDate>
      <description>First-of-its kind tool to guide HCPs on what to consider when staging patients with Mycosis Fungoides and Sézary SyndromePRINCETON, N.J., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin, Inc. a wholly owned subsidiary of Kyowa Kirin Co. Ltd, today announced the launch of a new tool to help healthcare providers (HCPs) navigate the complicated process of accurately staging patients with Mycosis Fungoides (MF) or Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL). The</description>
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      <title>Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kyowa-kirin-announces-abstract-presentation-at-the-european-academy-of-dermatology-and-venereology-eadv-congress</link>
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      <pubDate>Tue, 29 Jul 2025 12:00:00 GMT</pubDate>
      <description>Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025.</description>
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      <title>Kura Oncology and Kyowa Kirin Report Positive Updated Combination Data for Ziftomenib in Newly Diagnosed AML at 2025 European Hematology Association Congress</title>
      <link>https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-report-positive-updated-combination-data-for-ziftomenib-in-newly-diagnosed-aml-at-2025-european-hematology-association-congress</link>
      <guid isPermaLink="true">https://6ix.com/company/kyowa-kirin-co-ltd/news/kura-oncology-and-kyowa-kirin-report-positive-updated-combination-data-for-ziftomenib-in-newly-diagnosed-aml-at-2025-european-hematology-association-congress</guid>
      <pubDate>Thu, 12 Jun 2025 11:30:00 GMT</pubDate>
      <description>– Encouraging clinical activity with deep responses demonstrated in the KOMET-007 trial with the combination of 600 mg ziftomenib with 7+3 in newly diagnosed patients with NPM1-m and KMT2A-r AML – – 93% (41/44) and 89% (24/27) CRc observed in NPM1-m and KMT2A-r AML response-evaluable patients, respectively – – 71% (24/34) and 88% (14/16) CR measurable residual disease (MRD)-negativity observed among responding NPM1-m and KMT2A-r AML patients, respectively – – 96% (47/49) of NPM1-m and 88% (29/33</description>
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