Collaboration Overview - Kura Oncology and Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib, a selective oral menin inhibitor for treating acute myeloid leukemia (AML) and other hematologic malignancies [1] - Kura will receive a $330 million upfront payment and up to $1.2 billion in total milestone payments, including $420 million in near-term milestone payments [1][2] - The collaboration includes a 50/50 profit share in the U.S., with Kura leading U.S. development and commercial activities, while Kyowa Kirin has exclusive commercialization rights outside the U.S. [1][3][4] Financial and Commercial Terms - Kura is eligible for additional milestone payments totaling $741 million, bringing the total potential payments to $1.161 billion, including the opt-in for solid tumor indications [2] - In the U.S., Kura will book sales and lead commercial strategy, sharing profits and losses equally with Kyowa Kirin [3][9] - Outside the U.S., Kyowa Kirin will lead commercialization, and Kura will receive tiered double-digit royalties on net product sales [4][9] Development and Clinical Plans - The companies will jointly pursue a broad development program targeting acute leukemias, including frontline indications, combinations with targeted therapies, and post-transplant maintenance settings [1][6] - Kura anticipates that the collaboration funding, combined with its current cash balance, will support the AML program through commercialization in frontline combination therapy [1][8] - The companies plan to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years [10] Regulatory and Market Potential - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed/refractory NPM1-mutant AML, a mutation associated with poor outcomes [6][14] - Kura expects to submit a New Drug Application (NDA) in 2025 and initiate registrational Phase 3 frontline studies in both fit and unfit AML patient populations in 2025 [6][8] - The U.S. market opportunity for ziftomenib in the frontline setting is estimated at up to $3 billion annually [8] Additional Collaboration Details - Kura will fund development costs until the end of 2028, after which both companies will share costs at a 50:50 ratio [10] - Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications, with Kura eligible for additional upfront and milestone payments totaling $228 million if the option is exercised [11] - The collaboration excludes Kura's ongoing efforts to advance next-generation menin inhibitor drug candidates targeting oncology indications, diabetes, and other metabolic diseases [11]

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Rocatinlimab Met Co-Primary Endpoints of vIGA-ADTM 0/1 with a ≥ 2-Point Reduction from Baseline, EASI-75, and All Key Secondary Endpoints HORIZON is the First of Eight Phase 3 Trials in the ROCKET Program TOKYO, Sept. 25, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (Kyowa Kirin) (TSE:4151) (President and CEO: Masashi Miyamoto) announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. HORIZON met its co-primary endpoints: achievemen ...

Core Insights - Kyowa Kirin will present new research on burosumab treatment for X-linked hypophosphatemia (XLH) at the ASBMR 2024 annual meeting, highlighting real-world experiences and the disease's impact on patients [1][3] Research Presentation Details - An oral presentation titled "Patient reported outcomes (PRO) from a real-world study of burosumab treatment in adults with X-linked hypophosphatemia in the UK" will be delivered by Judith Bubbear, MD, on September 28 [2] - Multiple poster presentations will cover various aspects of burosumab's effectiveness and patient experiences, including comparisons with conventional therapy and biochemical measurements [4][5] Disease Overview - X-linked hypophosphatemia is a rare genetic disease characterized by low phosphorus levels, leading to bone and muscle issues in both children and adults [6] - The condition results from excess production of fibroblast growth factor 23 (FGF23), causing the body to excrete too much phosphorus [6] Treatment Information - CRYSVITA (burosumab) is a monoclonal antibody that inhibits FGF23, helping to restore phosphorus reabsorption in the kidneys and enhance vitamin D production [7][8] - It is indicated for the treatment of XLH in patients aged 6 months and older [8] Company Background - Kyowa Kirin is a Japan-based global specialty pharmaceutical company focused on drug discovery and biotechnology innovation, with over 70 years of experience [20]

PRINCETON, N.J., Aug. 23, 2024 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, is announcing that it will no longer distribute or fulfill orders for Fareston (toremefine) 60 mg tablets in the United States, effective August 31, 2024. This decision aligns with the company's Vision for 2030 and its focus on the discovery, development and delivery of novel therapies for patients. Kyowa Kirin has previou ...

Investors looking for stocks in the Beverages - Alcohol sector might want to consider either Kirin Holdings Co. (KNBWY) or Diageo (DEO) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look. There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The Zacks Rank favors stocks with strong ...

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A key driver of the new manufacturing facility is the growing global imperative to treat diseases that individually are rare, but which collectively affect an estimated 263 to 446 million people worldwide.1 Kyowa Kirin is uniquely positioned to fulfill the unmet needs of patients living with rare and underserved diseases by continuing to build on its more than 70-year history of discovering and developing novel medicines that offer life-changing value to patients. The Sanford facility will round out and enh ...

Kirin Holdings Co. (KNBWY) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The ...