Myriad Submits sPMA for BRACAnalysis CDx Test

Date : 01/21/2020 @ 12:58PM
Source : Dow Jones News
Stock : AstraZeneca PLC (AZN)
Quote : 50.17  1.23 (2.51%) @ 1:00AM
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Myriad Submits sPMA for BRACAnalysis CDx Test

Myriad Genetics (NASDAQ:MYGN)
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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.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

January 21, 2020 07:43 ET (12:43 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.

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