Last $39.68 USD
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myriad genetics inc (MYGN) Key Developments

Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)

Myriad Genetics Inc. announced that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis(r) testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.

Tesaro, Inc. to Use Myriad's Novel HRD Test to Identify Tumor Types

Myriad Genetics Inc. announced that Tesaro Inc. will use Myriad's novel HRD (homologous recombination deficiency) test to identify tumor types that may respond to its investigational poly-ADP ribose polymerase (PARP) inhibitor, niraparib, currently in Phase 3 clinical development. Specific terms of the deal were not disclosed. The research agreement with Tesaro is Myriad's fifth collaboration with a major pharmaceutical company to evaluate HRD.

Myriad Genetics Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Half Year Ended December 31, 2013; Revises Earnings Guidance for the Year Ending June 30, 2014

Myriad Genetics Inc. reported unaudited consolidated earnings results for the second quarter and half year ended December 31, 2013. For the quarter, the company reported total revenue of $204,060,000 against $149,140,000 a year ago. Operating income was $82,999,000 against $55,586,000 a year ago. Income before income taxes was $84,144,000 against $56,985,000 a year ago. Net income was $50,360,000 or $0.66 per diluted share against $35,036,000 or $0.42 per diluted share a year ago. For the half year, the company reported total revenue of $406,527,000 against $282,577,000 a year ago. Operating income was $165,903,000 against $104,168,000 a year ago. Income before income taxes was $167,971,000 against $106,807,000 a year ago. Net income was $105,825,000 or $1.33 per diluted share against $65,172,000 or $0.78 per diluted share a year ago. The company is raising its revenue expectations for fiscal year ending June 30, 2014. The company is now forecasting revenues of $740 to $750 million, compared to previous guidance of $700 to $715 million. This new guidance represents 21% to 22% revenue growth when compared to the prior fiscal year and incorporates the company's projection for approximately $10 million in revenue from the Crescendo acquisition, the completion of which is subject to regulatory clearance and satisfaction of customary closing conditions. The company also is increasing its diluted earnings per share guidance for fiscal year 2014. The company is projecting diluted earnings per share of $2.09 to $2.12 compared to previous guidance of $1.92 to $1.97. This new guidance represents 18% to 20% EPS growth. While this guidance does not contemplate additional share repurchase activity, Myriad is committed to its share repurchase program and expects that it will have sufficient cash reserves to complete the acquisition of Crescendo Bioscience and continue repurchasing shares under its current $300 million repurchase authorization.

Myriad Genetics Inc. Announces Results from PROCEDE 500

Myriad Genetics Inc. announced results from PROCEDE 500, a clinical utility study with its Prolaris test, at the 2014 ASCO Genitourinary Cancers Symposium in San Francisco, Calif. The study demonstrated the significant clinical value of Prolaris to physicians who are treating men with prostate cancer. Prolaris is a prognostic test that accurately predicts prostate cancer-specific death and metastases and has been validated in 11 clinical studies with more than 5,000 patients. PROCEDE 500 is an ongoing prospective registry study designed to examine the clinical utility of Prolaris. Currently, 331 patients have been enrolled and 150 clinicians have completed surveys in 305 cases to assess the influence of the Prolaris score on clinical decision making. Results for these interim data show that in 65% of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. In 40% of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25% of cases, physicians increased treatments including the use of surgery or radiation, and in 35% of cases, physicians did not change their treatment plans. Prolaris is a novel RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of 31 genes related to the progression of tumor cell division. Low gene expression is associated with a low risk of disease progression in men who may be candidates for surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 5,000 patients.

Myriad Genetics Inc., Q2 2014 Earnings Call, Feb 04, 2014

Myriad Genetics Inc., Q2 2014 Earnings Call, Feb 04, 2014

 

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