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News Breaks
June 1, 2013
14:59 EDTMYGN, AZNAstraZeneca advances PARP inhibitor into Phase 3 trial with BRACAnalysis
Myriad Genetics (MYGN) announced that AstraZeneca (AZN) will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption, IDE, with the FDA for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States. While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic -- following review by FDA -- to help select patients who are likely to respond to poly ADP ribose polymerase, PARP, inhibitors, a novel, targeted class of promising cancer therapeutics. Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
News For MYGN;AZN From The Last 14 Days
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March 26, 2015
11:13 EDTAZNBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:04 EDTMYGNOn The Fly: Analyst Downgrade Summary
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06:07 EDTMYGNMyriad Genetics downgraded to Sell from Neutral at Goldman
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March 23, 2015
09:45 EDTAZNUBS to hold a field trip
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09:06 EDTAZNInsmed appoints Eugene Sullivan as Chief Medical and Scientific Officer
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09:03 EDTAZNLeerink analysts hold a meeting with a conference call hookup
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07:36 EDTAZNPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
March 20, 2015
07:55 EDTAZNAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTMYGNAmerican Academy of Dermatology to hold annual meeting
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05:17 EDTMYGNMyriad EMPATHY-P clinical study results to be highlighted at annual congress
Myriad Genetics announced that results from the EMPATHY-P clinical study of Prolaris in patients newly diagnosed with prostate cancer will be highlighted at the 30th Annual Congress of the European Association of Urology. The EMPATHY-P study evaluated the Prolaris test on 525 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. The patients' biopsy samples also were evaluated using standard clinical pathology methods, which were then compared to the Prolaris test results. The EMPATHY-P data showed, overall, that the Prolaris test found 42% of the European men evaluated had a risk profile that was either lower or higher than would be expected using clinical pathology. Interestingly, this finding is consistent with the previously published U.S. Prostate Biopsy Research study, which found 51% of U.S. patients had a risk profile that differed from clinical pathology.
March 19, 2015
08:37 EDTAZNNektar and Daiichi Sankyo to commercialize Movantik in the U.S.
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March 17, 2015
14:10 EDTAZNIGI Laboratories recent sell-off a buying opportunity, says Craig-Hallum
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07:18 EDTMYGNMyriad Genetics announces collaboration expansion with BioMarin
Myriad Genetics (MYGN) announced an expansion of the company's collaboration with BioMarin Pharmaceutical (BMRN). Under the expanded collaboration, BioMarin will use Myriad's myChoice HRD companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib. Financial terms were not disclosed.
March 16, 2015
07:30 EDTAZNAmerican College of Cardiology to hold an expo
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