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...
treatment News
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...
AURORA, Colo., and ZAGREB, Croatia – Taiga Biotechnologies, a cell-based immunotherapy company, announced today that the Company has completed the site initiation session for the first site to participate in the TBX-2400-01 clinical trial, a Phase 1/2 study to evaluate the safety and early efficacy of TBX-2400 in acute myeloid leukemia...
PRINCETON, N.J. — Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). The ASCERTAIN trial was the first Phase 3...
Princeton, N.J. and Cambridge, Mass. — Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC). These data will be presented at the IASLC 2025 World Conference on Lung...
PRINCETON, N.J. — Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive...