Myriad Will Seek FDA Approval of BRACAnalysis CDx® As a Companion Diagnostic for Lynparza® (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer
Myriad Genetics, Inc. (MYGN)
Last myriad genetics, inc. earnings: 2/6 04:05 pm
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Source: GlobeNewswire
SALT LAKE CITY, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, today announced that the AstraZeneca/Merck Phase III PROfound study (NCT02987543) demonstrated that men with metastatic castration-resistant prostate (mCRPC) cancer who tested positive for germline and somatic mutations in homologous recombination repair genes benefitted from treatment with Lynparza® (olaparib), a novel PARP inhibitor. Myriad will file a supplementary Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC patients with germline BRCA mutations. “The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “This study is another ex
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MYGN
Earnings
- 11/7/24 - Beat
MYGN
Sec Filings
- 11/14/24 - Form SC
- 11/8/24 - Form 10-Q
- 11/7/24 - Form 8-K
- MYGN's page on the SEC website