Kirin Holdings(KNBWY)

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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)
Globenewswire· 2025-10-01 11:01
Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML) [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the significance of FLT3 as a target [1] - The KOMET-007 clinical trial has commenced, focusing on ziftomenib's efficacy alongside cytarabine, daunorubicin, and quizartinib for newly diagnosed AML patients [1][2] Company Overview: Kura Oncology - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [4] - Ziftomenib, a menin inhibitor, is under development to address specific genetic drivers of acute myeloid leukemias [4] Company Overview: Kyowa Kirin - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5] - The company is committed to developing novel medicines and treatments for high unmet medical needs, including hematological diseases and rare diseases [5]
Kura Oncology and Kyowa Kirin Announce First Patient Dosed in Pivotal Phase 3 KOMET-017 Trial of Ziftomenib for Frontline Acute Myeloid Leukemia (AML)
Globenewswire· 2025-09-29 20:01
– 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 announced that ...
Kyowa Kirin Premiers New CTCL Staging Tool for Healthcare Providers
GlobeNewswire News Room· 2025-08-19 13:01
Company Overview - Kyowa Kirin, Inc. is a wholly owned subsidiary of Kyowa Kirin Co. Ltd, focused on developing solutions for rare diseases, particularly in oncology [1][5] - The company has over 70 years of experience in drug discovery and biotechnology innovation, aiming to deliver novel medicines and treatments with life-changing value [7] Industry Context - Cutaneous T-cell lymphoma (CTCL) is a rare form of blood cancer that primarily affects the skin, with Mycosis Fungoides (MF) and Sézary Syndrome (SS) being the most common subtypes [2][6] - Diagnosis of CTCL can be challenging, often taking patients 2-7 years to receive an accurate diagnosis, which can lead to worse prognoses [2][5] Product Launch - Kyowa Kirin has launched a new staging tool for healthcare providers to assist in the accurate staging of patients with MF and SS, available on PROBEinCTCL.com [1][5] - The tool simplifies the staging process by using up to 20 Yes/No questions and real clinical case imagery, guiding users through the TNMB system [3][4] Clinical Relevance - The staging tool is designed to enhance clinical judgment by translating complex guidelines into a practical assessment, thereby supporting more consistent and informed care [2][3] - The tool is based on established guidelines from the National Comprehensive Cancer Network and recommendations from various oncology organizations [4]
Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress
Prnewswire· 2025-07-29 12:00
Company Overview - Kyowa Kirin Co., Ltd. is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [7] - The company focuses on developing novel medicines and treatments for high unmet medical needs, including bone & mineral diseases, hematological diseases, and rare diseases [7] Product Development - Rocatinlimab is an investigational anti-OX40 human monoclonal antibody targeting moderate to severe atopic dermatitis, with the potential to be the first T-cell rebalancing therapy [5][6] - The Phase 3 ROCKET IGNITE trial results for rocatinlimab will be presented at the EADV 2025 Annual Meeting in Paris from September 17-20, 2025 [1][3] - The ROCKET program consists of eight studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [3] Market Context - Atopic dermatitis affects 15-20% of children and up to 10% of adults, characterized by chronic symptoms and unpredictable flare-ups [4] - The disease is driven by T-cell imbalance, which is a root cause of its inflammatory nature [2][4] Collaboration - Kyowa Kirin has a collaboration agreement with Amgen to jointly develop and commercialize rocatinlimab, with Amgen leading development globally except in Japan [8]
Kura Oncology and Kyowa Kirin Report Positive Updated Combination Data for Ziftomenib in Newly Diagnosed AML at 2025 European Hematology Association Congress
GlobeNewswire News Room· 2025-06-12 11:30
Core Insights - The KOMET-007 trial demonstrated encouraging clinical activity for ziftomenib in combination with 7+3 for newly diagnosed NPM1-m and KMT2A-r AML patients, showing high rates of complete remission and minimal residual disease negativity [1][2][4] Group 1: Clinical Data - In the KOMET-007 trial, 93% (41/44) of NPM1-m patients and 89% (24/27) of KMT2A-r patients achieved complete remission composite (CRc) [1] - Among responding patients, 71% (24/34) of NPM1-m and 88% (14/16) of KMT2A-r patients achieved measurable residual disease (MRD) negativity [1] - The median follow-up times were 24.9 weeks for NPM1-m patients and 15.7 weeks for KMT2A-r patients, with 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remaining alive [3] Group 2: Safety and Tolerability - The safety profile of ziftomenib was consistent with previous data, with Grade 3 adverse events occurring in over 10% of patients, including febrile neutropenia (15%) and decreased platelet count (15%) [4] - No dose-limiting toxicities or additive myelosuppression were observed, indicating a favorable safety profile for ziftomenib [4] Group 3: Future Developments - Kura Oncology plans to initiate the KOMET-017-IC and NIC Phase 3 studies in the second half of 2025 to further evaluate ziftomenib's efficacy in AML treatment [1][5] - A virtual investor event is scheduled for June 18, 2025, to discuss the results and broader development plans for ziftomenib [6] Group 4: Company Background - Kura Oncology is focused on developing precision medicines for cancer, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML [7] - Kyowa Kirin, a partner in the development of ziftomenib, has a long history in drug discovery and biotechnology innovation, aiming to address high unmet medical needs [9]
Kirin Holdings: Q1 Performance Had Mixed Takeaways
Seeking Alpha· 2025-05-21 16:57
Core Viewpoint - The research service "Asia Value & Moat Stocks" targets value investors looking for Asia-listed stocks that exhibit a significant disparity between market price and intrinsic value, focusing on deep value balance sheet bargains and wide moat stocks [1] Group 1: Investment Focus - The service emphasizes deep value balance sheet bargains, which include net cash stocks, net-nets, low price-to-book (P/B) stocks, and sum-of-the-parts discounts [1] - It also highlights wide moat stocks, which are characterized by strong earnings power at a discount, including high-quality businesses and hidden champions [1] Group 2: Market Emphasis - The primary focus of the investment ideas is on the Hong Kong market, providing a range of watch lists with monthly updates for investors [1]
KNBWY vs. BUD: Which Stock Is the Better Value Option?
ZACKS· 2025-02-28 17:46
Core Viewpoint - The comparison between Kirin Holdings Co. (KNBWY) and Anheuser-Busch Inbev (BUD) indicates that KNBWY is currently a more attractive option for value investors due to its stronger earnings outlook and favorable valuation metrics [1][3][7]. Valuation Metrics - KNBWY has a forward P/E ratio of 12.22, while BUD has a forward P/E of 16.67, suggesting KNBWY is undervalued compared to BUD [5]. - The PEG ratio for KNBWY is 0.95, indicating better expected EPS growth relative to its price, whereas BUD has a PEG ratio of 1.93 [5]. - KNBWY's P/B ratio is 1.10, compared to BUD's P/B of 1.20, further supporting KNBWY's valuation advantage [6]. Investment Grades - KNBWY holds a Zacks Rank of 2 (Buy), while BUD has a Zacks Rank of 3 (Hold), reflecting a more favorable earnings estimate revision trend for KNBWY [3]. - KNBWY has earned a Value grade of A, while BUD has a Value grade of C, indicating KNBWY is perceived as a better value investment [6].
Are Investors Undervaluing Kirin (KNBWY) Right Now?
ZACKS· 2025-02-28 15:46
Core Viewpoint - The article emphasizes the importance of value investing and highlights Kirin (KNBWY) as a strong candidate for value investors due to its favorable valuation metrics [2][5]. Valuation Metrics - Kirin (KNBWY) has a Zacks Rank of 2 (Buy) and a Value grade of A, indicating it is a high-quality value stock [3]. - The stock is currently trading at a P/E ratio of 12.35, which is lower than the industry average of 14.97 [3]. - KNBWY's Forward P/E has fluctuated between 11.06 and 14.14 over the past 12 months, with a median of 12.56 [3]. - The P/S ratio for KNBWY is 0.72, compared to the industry average of 1.31, suggesting it is undervalued based on sales [3]. - The P/CF ratio for KNBWY is 10.89, significantly lower than the industry average of 42.52, indicating a strong cash outlook [4]. Investment Outlook - The combination of these metrics suggests that Kirin is likely undervalued, making it an attractive option for value investors [5].
Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025
Prnewswire· 2025-02-26 13:00
Core Insights - Kyowa Kirin Co., Ltd. announced the presentation of Phase 3 ROCKET HORIZON trial results for rocatinlimab, targeting OX40 receptor in moderate-to-severe atopic dermatitis, at the AAD 2025 Annual Meeting [1][2] Group 1: Clinical Trial Details - ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial involving 726 adult patients, assessing the efficacy, safety, and tolerability of rocatinlimab administered subcutaneously every four weeks for 24 weeks [3] - Co-primary endpoints include achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 or 1 with a ≥ 2-point reduction from baseline at week 24, and a ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24 [3] - Key secondary endpoints focus on the impact of rocatinlimab on itch, safety, and tolerability [3] Group 2: Atopic Dermatitis Overview - Atopic dermatitis is a chronic inflammatory disease affecting 15-20% of children and up to 10% of adults, characterized by excessively dry, itchy skin and unpredictable flare-ups [4] - T-cell imbalance is identified as a root cause of atopic dermatitis, contributing to its clinical manifestations [4] Group 3: Rocatinlimab Overview - Rocatinlimab is an anti-OX40 receptor human monoclonal antibody under investigation for moderate-to-severe atopic dermatitis, as well as for moderate to severe uncontrolled asthma and prurigo nodularis [5] - The antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology [5] Group 4: Collaboration with Amgen - Kyowa Kirin and Amgen entered a collaboration agreement on June 1, 2021, for the joint development and commercialization of rocatinlimab, with Amgen leading the global development except in Japan [6] - If approved, both companies will co-promote rocatinlimab in the United States, with Kyowa Kirin having opt-in rights for co-promotion in select markets [6]
KNBWY or BUD: Which Is the Better Value Stock Right Now?
ZACKS· 2025-02-12 17:41
Core Insights - The article compares Kirin Holdings Co. (KNBWY) and Anheuser-Busch Inbev (BUD) to determine which stock is more attractive for value investors [1] Valuation Metrics - Kirin Holdings Co. has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while Anheuser-Busch Inbev has a Zacks Rank of 4 (Sell) [3] - KNBWY has a forward P/E ratio of 11.30, compared to BUD's forward P/E of 14.37, suggesting KNBWY is undervalued [5] - KNBWY's PEG ratio is 0.88, while BUD's PEG ratio is 1.66, indicating KNBWY has a better expected earnings growth relative to its price [5] - KNBWY has a P/B ratio of 1.01, slightly lower than BUD's P/B of 1.03, further supporting KNBWY's valuation advantage [6] - Based on these metrics, KNBWY holds a Value grade of A, while BUD has a Value grade of C, reinforcing KNBWY as the superior value option [6]