IDEAYA Biosciences Gets Fast-Track Designation for IDE161 for Breast Cancer
27 Setembro 2023 - 7:43AM
Dow Jones News
By Chris Wack
IDEAYA Biosciences said Wednesday that the U.S. Food and Drug
Administration has granted fast-track designation to its
development program investigating IDE161 for the treatment of adult
patients having advanced or metastatic hormone receptor positive,
Her2- breast cancer with germline or somatic BRCA 1/2
mutations.
IDE161 is the company's potent and selective inhibitor of poly
glycohydrolase in both BRCA1/2-mutant breast and ovarian
cancers.
Fast track is a U.S. FDA process designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need.
IDEAYA's Phase 1 first-in-human clinical trial is evaluating the
safety, tolerability, pharmacokinetic and pharmacodynamic
properties and preliminary efficacy of IDE161 in patients having
solid tumors with homologous recombination deficiency.
IDEAYA is targeting program updates for IDE161 in the fourth
quarter of 2023. The company owns or controls all commercial rights
in IDE161, subject to certain economic obligations under its
exclusive, worldwide license with Cancer Research UK and University
of Manchester.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 27, 2023 06:28 ET (10:28 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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