SAN DIEGO, Calif. and TOKYO, Japan — Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that the first patient has been dosed under the KOMET-017 clinical trial protocol (NCT07007312), comprising two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib,...
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SAN DIEGO, Calif. and TOKYO, Japan — Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory...
SAN DIEGO, Calif. and TOKYO, Japan — Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced new data demonstrating a favorable safety profile and encouraging antileukemic activity for KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine (ven/aza) for the treatment of acute...
SAN DIEGO, Calif. — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in KOMET-008, the Company’s Phase 1 trial of its menin inhibitor ziftomenib, in combination with...
SAN DIEGO, Calif. — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported preliminary clinical data from the first 20 patients in KOMET-007, a Phase 1 dose-escalation trial of the Company’s potent and selective menin...
Cincinnati, Ohio – Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients. Kurome plans to initiate the clinical trial...
NOVATO, Calif. — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that it has received notice of priority review status for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for patients with phenylketonuria (PKU) from Health Canada. Priority review provides for a shortened submission review of 180 days versus the standard twelve...
NAARDEN, The Netherlands — Kynexis, a biotechnology company focused on precision therapeutics by leveraging biomarkers and human genetics for brain diseases, announced today that the first healthy volunteers have been dosed in its first-in-human phase 1 study of KYN-5356. KYN-5356, a clinical-stage small molecule targeting a key enzyme in the...
TOKYO, LONDON and BOSTON — Kyowa Kirin Co., Ltd., (TSE: 4151, President and COO: Abdul Mullick, “Kyowa Kirin”) and Orchard Therapeutics announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Regenerative Medicine Product Designation to OTL-200, also known as atidarsagene autotemcel, an investigational ex vivo autologous...
LONDON – The National Institute for Health and Care Excellence (NICE) today published its final appraisal document (FAD) for POTELIGEO® (mogamulizumab) announcing that POTELIGEO will not be made available on the NHS[1] in England and Wales. Mogamulizumab is a treatment for adults living with rare blood cancers, mycosis fungoides (MF) and...