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A large clinical trial has found that postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to as many as three lymph nodes and who have a 21-gene recurrence score (RS) of 25 or lower can safely skip having chemotherapy and...
WALTHAM, Mass. — Syndax Pharmaceuticals Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML). Topline data is expected in the fourth...
WALTHAM, Mass. and WILMINGTON, Del. – Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) and Incyte (Nasdaq: INCY) announced today that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody. “This partnership has the potential to significantly expand and maximize the axatilimab...
CAMBRIDGE, Mass. – Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it has initiated the Phase 1 clinical trial of SYNB1934, an investigational Synthetic Biotic™ medicine for the treatment of Phenylketonuria (PKU). “We are delighted to have so quickly advanced...
CAMBRIDGE, Mass. – Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced positive data from clinical studies evaluating both SYNB1618 and SYNB1934, investigational Synthetic Biotic™ medicines for the treatment of phenylketonuria (PKU). SYNB1618 demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, in...
CAMBRIDGE, Mass. — Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, announced today the publication of a manuscript detailing the development and activity of SYNB1353 in preclinical models and demonstrating safety, tolerability, and clinical proof of mechanism in healthy volunteers through...
CAMBRIDGE, Mass. – Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, announced today the publication of two papers in the journals Nature Metabolism and Communications Biology. The publications detail findings from a first-in-human study of investigational Synthetic Biotic™ medicine SYNB1618 and the development of a mechanistic model to...
WILMINGTON, Del. — AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration...