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2025-07-17
Kyowa Kirin Co., Ltd., Q2 2025 Earnings Call, Aug 01, 2025
2025-06-12
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. provided positive updated clinical data from KOMET-007, a Phase 1a/1b trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care in patients with newly diagnosed NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data for the combination with cytarabine/daunorubicin (7+3) were presented as an oral presentation at the European Hematology Association 2025 Congress (EHA2025) being held in Milan, Italy from June 12-15, 2025. In the ongoing study, ziftomenib dosed once daily at 600 mg in combination with 7+3 continued to demonstrate robust and evolving clinical activity in patients with newly diagnosed AML. Among 71 response-evaluable patients, 92% (65/71) achieved a composite complete remission (CRc) (93% for NPM1-m, 89% for KMT2A-r patients) and 80% (57/71) achieved a complete remission (CR) (84% for NPM1-m, 74% for KMT2A-r patients) at the time of data cutoff. A rate of CR minimal residual disease (CR-MRD) negativity of 71% for NPM1-m with a median time to MRD negativity of 4.7 weeks and a rate of CR-MRD negativity of 88% for KMT2A-r patients with a median time to MRD negativity of 4.4 weeks were observed. Ziftomenib did not delay time to neutrophil and platelet count recovery, which was comparable to intensive chemotherapy regimens. Median follow-up times for the two populations were 24.9 weeks (range 4.3-47.1) in NPM1-m patients and 15.7 weeks (range 1.1-40.3) in KMT2A-r patients. Among response-evaluable NPM1-m patients, neither a median duration of CR nor a median overall survival (OS) had been reached. Among response-evaluable KMT2A-r patients, a median duration of CR was determined to be 25.6 weeks (95% CI, range 8.3-NE), and a median OS had not been reached. Notably, 96% (47/49) of NPM1-m patients and 88% (29/33) of KMT2A-r patients remained alive and on study. The safety population included 82 newly diagnosed adult patients with NPM1-m or KMT2A-r AML from the pooled Phase 1a/1b portions of the trial at the 600 mg QD dose of ziftomenib. The safety profile observed with ziftomenib was consistent with previously reported data. Ziftomenib-related adverse events (TRAEs) of = Grade 3 (Gr3), which occurred in more than 10% of patients were febrile neutropenia (15%), decreased platelet count (15%), anemia (11%) and decreased neutrophil count (11%). One case of differentiation syndrome (KMT2A-r, Gr3) was successfully managed by protocol-specified mitigation strategies. Two cases of investigator-assessed QTc prolongation (both KMT2A-r, Gr3) were reported; both patients were on other medications (posaconazole and/or piperacillin/tazobactam), which have been identified as potentially causing QT prolongation at the time of QT assessment. No dose-limiting toxicities, drug-drug interactions, clinically meaningful ziftomenib-associated QTc prolongation or additive myelosuppression were observed. The EHA2025 oral presentation highlighting ziftomenib combined with 7+3 in newly diagnosed (1L) NPM1-m and KMT2A-r AML, and an encore presentation of results from the KOMET-001 registrational trial of ziftomenib in relapsed/refractory (R/R) NPM1-m AML (also presented during EHA2025) are available in the Posters and Presentations section of the Kura website. The KOMET-017 protocol consists of 2 separate Phase 3 studies, which will investigate the benefits and risks of adding ziftomenib to standards of care treatments in patients newly diagnosed NPM1-m or KMT2A-r AML and which is registered at www.clinicaltrials.gov as NCT07007312.
2025-06-03
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced the presentation of positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML) in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from May 30 - June 3, 2025. Ziftomenib, a once the most common in AML, representing approximately 30% of cases, and there are no FDA-approved therapies specifically for this patient population. With these encouraging results and a PDUFA target action date of November 30, 2025, and partners at Kyowa Kirin look forward to supporting FDA with its review of the ziftomenib New Drug Application (NDA) and are well-positioned to meaningfully impact relapsed or refractory patients with NPM1 mutations. Ziftomenib, an once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the FDA for the treatment of R/R NPM1-m AML. Kura and Kyowa Kirin are conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -m and KMT2A-rearranged AML. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib; interactions with the FDA relating to NDA for ziftomenib; the anticipated timing of FDA approval of NDA and the potential to benefit patients with R/R NPM1 them AML. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks and potential to benefit patients with NPM1-m.
2025-06-02
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced the U.S. Food and Drug Administration (FDA) has accepted Kura's New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025. The NDA is based on results from the Phase 2 KOMET-001 registrational trial in R/R NPM1-m) AML (NCT #04067336). The NDA is based on Results from the Phase 2 KOMet-001 registrational trial inR/R NPM1-mutant (NPM1-m) AM L. In addition to BTD, ziftomenib has received Fast Track and Orphan Drug Designations. Adult patients with NPM1-m AML and select co-mutations and/or R/R disease have a poor prognosis, with median overall survival of only approximately 7.8 months in 2nd line, 5.3 months in 3rd line, and 3.5 months following the 4th line1. There are currently no FDA-approved therapies targeting NPM1-m AMl. Ziftomenib is a potent and selective, oral, investigational menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received BTD from the FDA for the treatment of adult patients with R/R AML with an NPM1 mutation based on data from Kura's KOMET-001 clinical trial. Kura and Kyowa Kirin are conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and treated with the FDA.
2025-05-15
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced that an abstract highlighting clinical data from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for presentation at the upcoming 2025 European Hematology Association (EHA) Congress, to be held in Milan, Italy, from June 12-15, 2025. KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, includingcytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at EHA will be from the Phase 1a dose-escalation and Phase 1b dose-exp expansion portions of the trial, in the cohort evaluating ziftomenib in combination With 7+3 in newly diagnosed patients with AML. In addition to the oral presentation, two abstracts for the KOMET-001 and KOMET-017 trials have been accepted for an encore presentation and publication, respectively. Session titles and information for all three abstracts are listed below and are now available on the EHAweb.org website. Updated data from the published abstract for KOMET-007 will be disclosed during the oral presentation. 5:00PM - 6:15PM CEST Location: Allianz MiCo, Milano Convention Centre, Auditorium Publication Number: S136 Ziftomenib in Relapsed/Refractory NPM1-m and KMT2A-r AML. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib; potential benefits of combining ziftomenib with intensive chemotherapy and the expected timing and presentation of results and data from clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks associated with regulatory bodies, risk associated with the treatment of the AML.
2025-04-23
Kyowa Kirin Co., Ltd. Presents at World Orphan Drug Congress USA 2025, Apr-24-2025 02:20 PM. Venue: Boston Convention & Exhibition Center, Boston, Massachusetts, United States. Speakers: Debra Jennings, Head of Patient Services Operations, North America.
2025-04-10
Kyowa Kirin Co., Ltd., ¥ 30.0, Cash Dividend, Jun-27-2025
2025-04-04
Kyowa Kirin Co., Ltd., Q1 2025 Earnings Call, May 01, 2025
2025-03-19
Kyowa Kirin Co., Ltd., Board Meeting, Mar 19, 2025. Agenda: To consider and approve to dispose of treasury shares used for restricted share-based remuneration and performance-linked share-based remuneration.
2025-03-08
AMGEN and Kyowa Kirin Co., Ltd. announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed. The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies. ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlim AB in adults and adolescents with moderate to severe atopic dermat inflammation (AD) as well as multiple dosing regimens.
2025-03-06
Follow up briefing on AAD conference presentation on rocatinlimab
2025-03-04
Garuda Therapeutics, Inc. announced that it has received $50 million in a round of funding on March 4, 2025. The transaction included participation from new investor Kyowa Kirin Co., Ltd. and existing investors, OrbiMed Advisors LLC, Northpond Ventures, LLC and Cormorant Asset Management, LP.
2025-02-26
Kyowa Kirin Co., Ltd. announced that results of the Phase 3 ROCKET HORIZON 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 American Academy of Dermatology (AAD) 2025 Annual Meeting to be held in Orlando, Florida from March 7-11, 2025. AD, a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell-dependent inflammatory pathways. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD. ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis. The trial includes 726 adult patients who were randomized to receive rocatinlimab or placebo administered through a subcutaneous injection every four weeks for 24 weeks with a loading dose at week two. Co-primary endpoints for the trial are achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) with a 2-point reduction from baseline at week 24 and achievement of 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24. (In the US, a more stringent Investigator Global Assessment, revised IGA (rIGA), replaces vIGA in the co-primary endpoint.) Key secondary endpoints included the impact of rocatinlimab on itch as well as safety and tolerability. ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe AD across multiple dosing regimens. Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry,itchy skin that can be painful. People with moderate to severe atopic Dermatitis experience chronic symptoms, amplified by unpredictable flare-ups that can be painful and disruptive to everyday life. Almost half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults. T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms. Rocatinlimab is an anti-OX40 receptor human monoclonal antibody being investigated for the treatment of moderate-to-severe atop dermatitis.ocatinlimab is also being studied for moderate to severe uncontrolled asthma and, prurigo nodularis. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority. On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen leads the development, manufacturing, and commercialization for rocatinlimab for all markets globally, except Japan, where Kyowa Kirin is currently under clinical investigation and the U.S. FDA, and any other regulatory authority.
2025-02-08
Kyowa Kirin Co., Ltd. provided dividend guidance for the second quarter and full fiscal Year Ended December 31, 2025. For the quarter, company expected to pay dividend of JPY 30.00 per share against dividend of JPY 29.00 per share for the previous period, For the full year, company expected to pay dividend of JPY 30.00 per share against dividend of JPY 29.00 per share for the previous period.
2025-02-08
Kyowa Kirin Co., Ltd. announced dividend of JPY 29.00 per share for the full fiscal year ended December 31, 2024 against dividend of JPY 29.00 per share for the previous period. Payable on March 21, 2025.
2025-02-08
Kyowa Kirin Co., Ltd. provided earnings guidance for the Fiscal Year Ending December 31, 2025. For the period, the company expects Revenue of JPY 478,00 million; Core operating profit of JPY 80,000 million; Profit to be JPY 57,000, Profit attributable to owners of parent JPY 57,000 million and Basic earnings per share of JPY 108.91.
2025-02-06
Kyowa Kirin Co., Ltd., Annual General Meeting, Mar 19, 2025.
2025-02-06
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). Topline data for KOMET-001 has been submitted for presentation at an upcoming medical conference in the second quarter of 2025, and Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025. The companies, which announced their joint collaboration to commercialize ziftomenib in 2024, also announced they plan to initiate a single protocol containing two independently powered, randomized, double-blind, placebo-controlled, registrational Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML, following successful interactions with the FDA. After successful FDA interactions in part facilitated by BTD, Kura announced that it is on track to submit an NDA to the FDA for ziftomenib for the treatment of patients with R/R NPM1-mutant AML in the second quarter of 2025; NDA submission for ziftomenib on track for second quarter of 2025; and Kyowa Kirin recently announced plans for KOMET-017, a global protocol evaluating ziftomenib in combined with standards of care for adults with newly diagnosed NPM1 -m or KMT2A-r AML. Following successful End-of-Phase 1 meetings with the FDA, the companies announced they will proceed with plans to initiate the KOMET-017 trial, comprising of two independent, global, randomized, double-blind., placebo-controlled Phase 3 trials to evaluate ziftsomenib in combination with bothintensive and non-intensive combination reg regimens in patients with newly diagnosis NPM1-m and/or KMT2A-rAML. The positive feedback from the FDA, along with data from the KOMET-007 trial presented at the 2024 American Society of Hematology Annual Meeting, reinforces Kura's and Kyowa Kirin's commitment to evaluating ziftomenib in patients across the continuum of frontline treatment options. Such forward-looking statements include statements regarding, among other things, the therapeutic potential and potential success of ziftomenib, KO-2806 and tipifarnib; plans, trial designs and expected timing of clinical trials; the expected timing and presentation of data from clinical trials; the anticipated timing of submission of a New Drug Application for ziftomenib; the potential for U.S. accelerated approval and full approval of product candidates; and the success and impact of interactions with the FDA. Factors that may cause actual results to differ materially include the risk that compounds that appear promising in early research or clinical trials do not demonstrate safety and safety and safety.
2025-02-06
To discuss Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs
2025-01-29
Kyowa Kirin Co., Ltd. Presents at World CDx & LBx Summit APAC, Nov-13-2024 02:25 PM. Venue: Conrad Centennial, 2 Temasek Blvd, Singapore , Singapore. Speakers: Tsuyoshi Morishita, Associate Director, Global Biomarker.
2025-01-23
Kyowa Kirin Co., Ltd. Presents at Veeva R&D and Quality Summit, Oct-31-2024 02:20 PM. Venue: Tokyo, Japan. Speakers: Masaki Ito, General Manager, Global Quality Management Department.
2025-01-20
Kyowa Kirin Co., Ltd., 2024 Earnings Call, Feb 07, 2025
2025-01-03
Kyowa Kirin Co., Ltd. announced that they will report Q1, 2025 results on May 01, 2025
2025-01-03
Kyowa Kirin Co., Ltd. announced that they will report Q2, 2025 results on Jul 31, 2025
2024-12-20
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced they have entered into a global strategic collaboration to develop and commercialize ziftomenib, Kura's selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies. Under the terms of the agreement, Kura will receive an upfront payment of $330 million and expects to receive up to $420 million in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting. In addition, Kura is eligible to receive additional development, regulatory and commercial milestone payments of $741 million, totaling up to $1.161 billion in payments for milestones and the opt-in for solid tumor indications. In the U.S., Kura will lead development, regulatory and commercial strategy and be responsible for manufacturing ziftomenib. The companies will jointly perform commercialization activities in accordance with a co-created U.S. territory commercialization plan and will share equally in any potential profits and losses. Outside the U.S., Kyowa Kirin will lead development, regulatory and commercial strategy and is responsible for commercializing ziftomenib. Kura will be eligible to receive tiered double-digit royalties on net product sales. As a Japan based global specialty pharmaceutical company, Kyowa Kirin aims to create treatments with life-changing value that bring smiles to people living with disease. The company will leverage its hemato-oncology experience and capabilities, and its deep commitment to partnerships, to successfully bring ziftomenib to market globally. Ziftomenib is the first and only investigational therapy to receive breakthrough designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R NPM1-mutant AML, a mutation that is associated with poor outcomes. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed and the companies anticipate submission of a New Drug Application (NDA) in 2025. Kura is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A- rearranged AML. Kura expects to initiate registrational Phase 3 frontline studies in both the fit and unfit frontline AML patient populations in 2025. Following regulatory approval, Kura will book sales and take the lead role in U.S. commercial strategy development and both parties will share in commercialization activities. Profits and losses from the commercialization activities will be shared equally in the U.S. Outside the U.S., Kyowa Kirin will lead and perform commercialization activities, book sales and be responsible for the conduct and funding of commercialization of ziftomenib, and Kura is eligible to receive tiered double-digit royalties on net product sales. As part of the strategic collaboration, the companies will share responsibility for the conduct of clinical trials delineated within an agreed-upon global development plan. For the global development plan, Kura will fund the development costs until the end of 2028, and from 2029 onwards, both companies will share the costs at a 50:50 ratio. The companies will share equally the funding of future trials in the U.S. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years. Development and commercialization activities under the collaboration will be managed through a shared governance structure. Under the Agreement, Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications upon opt-in after receipt of clinical data from the ongoing proof-of- concept study evaluating ziftomenib and imatinib in patients with advanced GIST not successfully treated with imatinib. If Kyowa Kirin exercises its option, Kura is eligible for upfront and milestone payments totaling $228 million and the parties' roles and responsibilities follow the same structure as the collaboration in AML and other heme malignancies. Excluded from the collaboration are Kura's ongoing efforts to advance multiple, next-generation menin inhibitor drug candidates targeting certain oncology indications, as well as diabetes and other metabolic diseases. Kura was advised in the transaction by BofA Securities and represented by Cooley LLP.
2024-12-10
Cimeio Therapeutics announced that it has entered a research collaboration with Kyowa Kirin Co., Ltd. to develop a novel therapy for diseases with high unmet need. The partnership combines Cimeio’s proprietary Shielded-Cell & Immunotherapy Pairs platform with Kyowa Kirin’s expertise in cellular therapies and underscores both companies’ commitment to using emerging cell and gene therapy technologies to develop new ways to treat patients. Under the terms of the agreement, Cimeio is eligible to receive an upfront payment and two years of research funding. Upon Kyowa Kirin’s exercise of a commercial license option, Cimeio will be eligible for development and commercial milestones as well as royalties on sales of potential products arising from the partnership. Further terms are not disclosed. Cimeio’s SCIP platform is based on the development of novel immunotherapies enabled by epitope-shielded cells. These cells contain modified variants of naturally occurring cell surface proteins that maintain their function but are resistant to depletion by the paired immunotherapy. These shielded cells enable the development of powerful therapeutics for previously undruggable targets, targeted conditioning for HSC transplant, and immune system reset amongst other applications.
2024-12-09
Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. provided encouraging clinical data from KOMET-007, a Phase 1 dose-escalation trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). These data were presented at the 2024 American Society of Hematology (ASH) Annual Meeting. An oral presentation highlighting ziftomenib combined with 7+3 in newly diagnosed (1L) NPM1-m and KMT2A-r adverse riski AML, and a poster featuring ziftomenib in combination with ven/aza in relapsed/refractory (R/R) NPM1-m & KMT2A-r AML are available in the Posters and Presentations section on Kura's website. Ziftomenib is a selective and oral menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R NPM1-mutant AML based on data from Kura's ongoing KOMET-001 clinical trial.
2024-11-20
To discuss about Global Strategic Collaboration between Kura Oncology and Kyowa Kirin to Develop and Commercialize Ziftomenib in Acute Leukemias
2024-11-20
Agreement for Global Strategic Collaboration with Kura Oncology to Develop and Commercialize Ziftomenib
2024-11-08
Sustainability meeting
2024-11-06
Kyowa Kirin Co., Ltd. Presents at 12th International mRNA Health Conference 2024, Nov-12-2024 04:00 PM. Venue: Boston, Massachusetts, United States. Speakers: Hiroto Iwai.
2024-10-31
Kyowa Kirin Co., Ltd. announced that Yutaka Osawa, Executive Vice President and Chief Compliance Officer (CCO), will retire in March 2025.
2024-10-11
From October 1, 2024 to October 10, 2024, the company has repurchased 1,378,900 shares, representing 0.26% for ¥3,594.05 million. With this, the company has completed the repurchase of 14,365,500 shares, representing 2.69% for ¥39,999.95 million under the buyback announced on February 7, 2024.
2024-10-11
The company closed its plan on October 10, 2024.
2024-10-10
Kyowa Kirin Co., Ltd., Q3 2024 Earnings Call, Oct 31, 2024
2024-10-02
From July 1, 2024 to September 30, 2024, the company has repurchased 3,002,100 shares, representing 0.57% for KRW 9,367.79 million. With this, the company has completed the repurchase of 12,986,600 shares, representing 2.43% for KRW 36,405.9 million under the buyback announced on February 7, 2024.
2024-09-19
Kyowa Kirin Co., Ltd. Presents at American Society for Bone & Mineral Research Annual Meeting 2024, Sep-26-2024 through Sep-30-2024. Venue: Toronto, Ontario, Canada. Presentation Date(s): Sep-27-2024. Sep-28-2024. Sep-29-2024.
2024-09-17
Kyowa Kirin Co., Ltd. Presents at DPHARM US 2024, Sep-17-2024 . Venue: Philadelphia, PA, Philadelphia, Pennsylvania, United States. Speakers: Mitchell Katz, SVP, Global Clinical Operations.
2024-09-06
R&D Day
2025Q2 | 2025Q1 | 2024Q4 | 2024Q3 | 2024Q2 | 2024Q1 | 2023Q4 | 2023Q3 | |
---|---|---|---|---|---|---|---|---|
Total Revenues | 493,238 | 494,714 | 495,558 | 498,978 | 475,998 | 454,267 | 442,233 | 420,649 |
Pretax Income Excl.Unusual Items | 70,103 | 73,213 | 94,648 | 113,664 | 119,946 | 101,989 | 99,471 | 91,881 |
Total Assets | 1,066,511 | 1,019,279 | 1,067,363 | 1,041,966 | 1,070,009 | 1,065,883 | 1,025,942 | 1,004,051 |
Total Liabilities | 224,530 | 187,858 | 216,552 | 206,718 | 207,321 | 221,914 | 189,524 | 191,908 |
Cash & Cash Equivalents | 234,603 | 214,370 | 244,681 | 296,333 | 311,135 | 333,120 | 403,083 | 382,266 |
Total Common Equity | 841,981 | 831,421 | 850,811 | 835,248 | 862,688 | 843,969 | 836,418 | 812,143 |
Book Value Per Share (BVPS) | 1,608.4 | 1,588.59 | 1,625.68 | 1,591.79 | 1,634.73 | 1,577.38 | 1,555.81 | 1,510.66 |
Net Change in Cash | -76,532 | -118,750 | -158,402 | -85,933 | -60,995 | -11,728 | 63,889 | 49,487 |
Capital Expenditure | -33,896 | -32,171 | -26,037 | -22,855 | -19,398 | -16,758 | -17,213 | -18,794 |
As of July 31, 2025, Kyowa Kirin published financial results for the second quarter of 2025, with revenues of 125.93B yen and net income of 10.15B yen, representing a revenue decrease of 1.2%, along with a sharp drop of approximately 55.5% in EPS compared with the same quarter last year.
In addition, the EBITDA margin droped sharply from 24.2% in the corresponding quarter last year to 14.2%. A decrease in operating profitability may indicate a difficulty in sales or an increase in operating expenses, potentially harming the stock's future performance. Another figure worth noting is the free cash flow for the quarter, which was 23.7B yen, an increase of 3.06B yen from the previous year's corresponding period. In response to the improvement in cash flow, the company's management paid a significant sum of 2M yen as a repurchase of Common Stock. It is important to note that the stock's dividend yield stands at approximately 2.3%, and it trades at 36x times current year's earnings, which is higher than the sector average (P/E 9.6x).