Myriad Genetics (NASDAQ:MYGN)
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2 Months : From Dec 2019 to Feb 2020
By Michael Dabaie
Myriad Genetics Inc. (MYGN) said it submitted a supplementary premarket approval application to the U.S. Food and Drug Administration.
The sPMA is for the company's BRACAnalysis CDx test as a companion diagnostic to AstraZeneca PLC's (AZN) and Merck & Co.'s (MRK) Lynparza for men with metastatic castration-resistant prostate cancer.
AstraZeneca and Merck said Tuesday the supplemental New Drug Application for Lynparza was been accepted and granted priority review by the FDA.
Myriad said the filing for BRACAnalysis CDx is based on the positive clinical results from the PROfound study.
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(END) Dow Jones Newswires
January 21, 2020 07:43 ET (12:43 GMT)
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