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...
treatment News
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...
LONDON – The National Institute for Health and Care Excellence (NICE) has upheld an appeal lodged by Kyowa Kirin, Lymphoma Action and Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) as part of the Single Technology Appraisal for POTELIGEO® (mogamulizumab) for the treatment of adults with the ultra-rare blood cancers...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the signature of a collaboration agreement with Stanford University to allow the use of KYV-101, an investigational, anti-CD19 CAR T-cell therapy in an open label,...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced positive interim data from the Phase 2 portion of the registrational KYSA-6 clinical trial of KYV-101 in generalized myasthenia gravis (gMG). The data will be shared...