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Myriad Genetics (MYGN) Files For MyChoice CDx Test SPMA

Published 02/12/2020, 10:36 PM
Updated 07/09/2023, 06:31 AM

Myriad Genetics, Inc. (NASDAQ:MYGN) recently submitted a supplementary premarket approval (sPMA) application to the FDA for its myChoice CDx test. This will enable the identification of women suffering from advanced ovarian cancer who are prospective candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab.

With the receipt of approval, the company will take a major stride forward in its Oncology and Women’s Health segment.

More About myChoice CDx

myChoice CDx is the most wide-ranging homologous recombination deficiency test, helping physicians identify patients with tumors, who have increased exposure to DNA-damaging drugs such as platinum drugs or PARP inhibitors.

The company filed for the sPMA on the basis of favorable outcomes from the Phase 3 PAOLA-1 clinical trial of Lynparza that was published online in December 2019. The sPMA would ensure better outcomes for ovarian cancer patients through precision medicine and targeted therapies.

Market Prospects

Per ResearchandMarkets.com, the ovarian cancer treatment market is expected to see a CAGR of 7.02% to reach $2.51 billion by 2024.

Recent Development

In January 2020, Myriad Genetics submitted a sPMA application to the FDA for its myChoice CDx test to enable the prediction of outcomes of women affected with first-line platinum responsive advanced ovarian cancer, treated with GSK’s PARP inhibitor Zejula (niraparib). This filing was done on the basis of the favorable outcomes of the Phase 3 PRIMA trial of Zejula.

Price Performance

In the past year, the stock has underperformed its industry. The stock has lost 35.5%, compared with the industry’s 2.5% decline.

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Zacks Rank & Stocks Worth a Look

Myriad Genetics currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space are Hill-Rom (NYSE:HRC) , Stryker (NYSE:SYK) and ResMed (NYSE:RMD) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hill-Rom has a projected long-term earnings growth rate of 11.1%.

Stryker has an expected long-term earnings growth rate of 9.9%.

ResMed has a long-term earnings growth rate of 11.9%.

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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>



Stryker Corporation (SYK): Free Stock Analysis Report

ResMed Inc. (RMD): Free Stock Analysis Report

Myriad Genetics, Inc. (MYGN): Free Stock Analysis Report

Hill-Rom Holdings, Inc. (HRC): Free Stock Analysis Report

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