Kura Oncology

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.

Johnson & Johnson seeks approval for Darzalex to treat high-risk smoldering myeloma, with AQUILA trial showing reduced risk of disease progression. GSK's Blenrep, after withdrawal, shows improved survival in DREAMM-7 trial. Emerging efforts aim to ease conditioning for genetic treatments in sickle cell disease. Kura Oncology's menin inhibitor shows promising results in AML, facing competition from J&J and Syndax. Pfizer's Oxbryta withdrawal for sickle cell disease remains unexplained.

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Penn State College of Medicine, Beat Childhood Cancer Research Consortium, and Four Diamonds are launching a clinical trial to test a new drug combination for relapsed and refractory neuroblastoma, involving tipifarnib and naxitamab. The trial aims to improve treatment outcomes for children with neuroblastoma by enhancing the efficacy of immunotherapy.

Kura Oncology to participate in JMP Securities Hematology and Oncology Summit on Dec 2, 2024. The company is focused on precision medicines for cancer treatment, with ziftomenib as a key drug candidate.

Novartis acquires Kate Therapeutics for $1.1B, Barclays predicts challenging 2025 for European pharma, Trump picks surgeon Martin Makary to lead FDA, Novartis partners with Ratio Therapeutics for up to $745M, Kyowa Kirin pays Kura Oncology $330M upfront for leukemia drug rights, global measles cases rise 20% to 10.3 million, Brookfield considers €7B bid for Grifols, Bavarian Nordic's 2025 order book reaches €320M, FDA supports REGENXBIO's Duchenne muscular dystrophy gene therapy, Merck's subcutaneous Keytruda matches infused version, Syndax Pharmaceuticals secures FDA approval for Revuforj, Aclaris Therapeutics licenses 2 antibodies from Biosion for over $40M upfront, Sandoz to cut 10% of workforce in France, Incyte halts testing and discontinues drugs, Sage Therapeutics discontinues dalzanemdor, Johnson & Johnson and Merck announce job cuts in China, Samsung Biologics signs $668M contracts, FDA grants accelerated approval to Jazz Pharmaceuticals' Ziihera, Lexicon Pharmaceuticals cuts 60% of workforce, Halozyme withdraws €2B bid for Evotec, mpox epidemic overwhelms hospitals in Kinshasa.

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.