Kyowa Kirin, Inc.

Kura Oncology, with ziftomenib for AML, is undervalued; KOMET-001 trial results due Q1 2025. Strong cash reserves and Kyowa Kirin partnership bolster potential. Safety concerns and competitive AML landscape pose risks.

ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression in smoldering multiple myeloma, Arcellx's anito-cel showing comparable safety to Carvykti, and J&J/Legend's Carvykti improving survival outcomes. Kura Oncology's ziftomenib showed high response rates in leukemia, Eli Lilly's Jaypirca reduced disease progression risk, and Merck's zilovertamab vedotin achieved high complete response rates in lymphoma. Beam Therapeutics' BEAM-101 showed durable effects in sickle cell disease, Novo Nordisk's etavopivat reduced crises, and Bristol Myers Squibb's arlo-cel demonstrated durable responses in multiple myeloma. Galapagos' GLPG5101 showed encouraging cell therapy results, Orca Bio's Orca-T improved survival in blood cancers, and Sanofi's rilzabrutinib improved platelet response in thrombocytopenia. Regeneron's drug combo showed better disease control than Ultomiris in PNH.

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Halozyme withdrew offer to buy Evotec after refusal to engage; Neurogene's Rett syndrome gene therapy patient died from side effects; Argenx advances efgartigimod testing in myositis; Kyowa Kirin pays $330M upfront for Kura Oncology's leukemia drug; FDA's Douglas Throckmorton plans to retire.

Kura Oncology and Kyowa Kirin collaborate globally to develop and commercialize ziftomenib, a selective oral menin inhibitor for AML and other hematologic malignancies. Kura receives $330M upfront and up to $1.161B in milestone payments. Kura leads US development and commercialization, while Kyowa Kirin handles global commercialization, with Kura eligible for royalties. Ziftomenib, with FDA breakthrough designation for R/R NPM1-mutant AML, aims for NDA submission in 2025.

Kura Oncology secures $330 million from Kyowa Kirin for ziftomenib, a menin inhibitor targeting KMT2A-mutated leukemia, with plans for FDA submission in 2025. The collaboration aims to develop ziftomenib across leukemias and solid tumors, with potential milestone payments up to $1.2 billion.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

Amgen states no association between MariTide and bone mineral density changes, affirming its promise. Phase 2 data is expected later in 2024.