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MYGN

Myriad Genetics

$35.53

0.72 (2.07%)

11:22
01/12/18
01/12
11:22
01/12/18
11:22

FDA okays Myriads' BRACAnalysis as companion diagnostics for Lynparz

Myriad Genetics announced that the U.S. Food and Drug Administration approved BRACAnalysis CDx for use as a companion diagnostic by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza, marketed by AstraZeneca and Merck, known as MSD outside of the U.S. and Canada. BRACAnalysis CDx is the first and only FDA-approved test for use in this indication."This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA approved test to help ensure that they will receive the best available therapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics. "As shown in the OlympiAD study, Myriad's BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza."The approval also adds to the body of knowledge about the clinical use and value of companion diagnostics to enable personalized medicine for people with cancer.

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MYGN Myriad Genetics
$35.53

0.72 (2.07%)

09/22/17
SPHN
09/22/17
NO CHANGE
Target $40
SPHN
Overweight
Myriad Genetics price target raised to $40 from $36 at Stephens
Stephens analyst Drew Jones said that after the firm hosted a series of panels with healthcare industry professionals, he believes Myriad Genetics is well positioned to benefit from two key themes that came to the forefront - limiting risk and reducing cost. Jones, who noted that genetic testing was cited repeatedly as a potential lever for cost savings, reiterates his Overweight rating on Myriad and raised his price target on the stock to $40 from $36.
11/02/17
PIPR
11/02/17
NO CHANGE
PIPR
Neutral
Myriad trial hit two important secondary endpoints, says Piper Jaffray
Piper Jaffray analyst William Quirk notes shares of Myriad Genetics are sinking after its key growth asset GeneSight missed the primary endpoint from a large, double blind clinical trial. The study, though, hit two important secondary endpoints that may have a positive impact on longer-term private payer coverage, Quirk tells investors in a research note. The analyst believes the secondary endpoints "may prove to be more important for driving future revenue growth." He keeps a Neutral rating on shares of Myriad Genetics.
11/10/17
JPMS
11/10/17
NO CHANGE
Target $19
JPMS
Underweight
JPMorgan continues to see downside risk in Myriad Genetics
After conducting a survey of high-volume, U.S.-based psychiatrists to get a better sense of the traction GeneSight test is seeing and the longer term market opportunity, JPMorgan analyst Tycho Peterson continues to see risk to the downside in Myriad Genetics shares. Responses overall were mixed, with some indicating GeneSight provides meaningful clinical information while others were cautious on the utility of the test, Peterson tells investors in a research note. The analyst believes the failure of the GeneSight clinical utility study to hit the primary endpoint increases questions on Myriad's ability to gain meaningful incremental reimbursement. He keeps an Underweight rating on the shares with a $19 price target.
12/11/17
PIPR
12/11/17
NO CHANGE
PIPR
Overweight
Piper says CMS coding edits could negatively impact Myriad Genetics
The Centers for Medicare and Medicaid Services made an edit to its procedure guidelines, essentially stating labs should use code 81162, instead of combining 81211 and 81213, Piper Jaffray analyst William Quirk tells investors in a research note. The analyst believes Myriad Genetics bills BRCA tests using the two codes. As such, the edit by CMS could have financial implications for the company as 81162 is paid 21% lower than the combined 81211/81213 rate, Quirk points out. He notes, however, that Myriad management states these coding edits were expected and already factored into guidance. Quirk believes the company's outlook for the second half of 2018 "appears low enough," but he notes that this is the first he's heard about the CMS change. He has a Neutral rating on Myriad with a $29 price target. The stock in morning trading is down 3% to $32.66.

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