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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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October 24, 2014
09:05 EDTMYGNMyriad Genetics establishes tumor BRACAnalysis CDx lab in Europe
Myriad Genetics, announced it has established a Tumor BRACAnalysis CDx laboratory in Europe. Myriad's next-generation Tumor BRACAnalysis CDx test is a companion diagnostic that will identify up to 50% more patients with BRAC mutations who may benefit from treatment with PARP inhibitors, such as olaparib, compared to conventional germline testing alone. Olaparib is a novel PARP inhibitor being developed by AstraZeneca. Earlier today, the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, recommended marketing authorization for olaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated, or germline and/or somatic, high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy. It is estimated that more than 22% of all ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from olaparib therapy.
06:49 EDTAZNPfizer repurchase could squash AstraZeneca bid goal, Reuters says
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October 22, 2014
07:35 EDTAZNCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
07:15 EDTAZNFDA to hold workshop on breast cancer drug development
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06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
October 20, 2014
07:47 EDTAZNPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTAZNIBC Life Sciences to hold a conference
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07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
October 17, 2014
12:52 EDTMYGNOn The Fly: Midday Wrap
Stocks on Wall Street were sharply higher at midday, as the averages bounce back following steep declines in several recent sessions. Better than expected earnings from General Electric (GE) and Morgan Stanley (MS), a rebound in European stock markets and a stronger than expected reading on U.S. consumer confidence may all be contributing to the brightened mood evidenced by today's trading. ECONOMIC EVENTS: In the U.S., housing starts rebounded 6.3% to a 1.017M pace in September, beating expectations for a monthly increase of 4.6%. Building permits increased 1.5% to a 1.018M rate, which was below the expected 2.3% rise. The first release on the University of Michigan's consumer sentiment index for October came in at 86.4, versus expectations for a decline to 84.0 from the prior 84.6 reading. COMPANY NEWS: General Electric shares rose over 3% after the company reported better than expected third quarter profit and nearly in-line revenues. Morgan Stanley, whose quarterly results also topped Street expectations, advanced 2.5%. MAJOR MOVERS: Among the notable gainers was Westmoreland Coal (WLB), which gained 23% after it stuck a deal to acquire Oxford GP, the general partner of Oxford Resource Partners (OXF), and contribute certain royalty bearing coal reserves to Oxford in return for Oxford common units. Afterward, Brean Capital raised its price target on Westmoreland to $60, noting the announcement represents an entry into the MLP space. Also higher were shares of Textron (TXT), which advanced 11% after the aircraft and defense company reported better than expected third quarter earnings per share and raised its profit outlook for fiscal 2014. Among the noteworthy losers was Urban Outfitters (URBN), which dropped 13% and was downgraded by at least three Street research firms after the owner of Anthropologie and its namesake clothing stores warned that its Q3 earnings may be negatively impacted by continued weakness in its comparable retail sales. Also lower was Myriad Genetics (MYGN), which fell 7% after guiding to lower than expected Q1 adjusted earnings, citing a higher than expected increase in costs to perform its myRisk Hereditary Cancer test following the test's national launch. INDEXES: Near midday, the Dow was up 295.34, or 1.83%, to 16,412.58, the Nasdaq was up 62.43, or 1.48%, to 4,279.82, and the S&P 500 was up 29.48, or 1.58%, to 1,892.24.
07:16 EDTMYGNMyriad Genetics receives draft medicare coverage for Prolaris
Myriad Genetics announced that Palmetto GBA, a Medicare Administrative Contractor, or MAC, that assesses molecular diagnostic technologies, has issued a draft local coverage determination, or LCD, for Prolaris, Myriad's prostate cancer test. The LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services, or CMS, website and establishes the coverage policy for Medicare beneficiaries. The current language in the draft LCD provides reimbursement coverage for the approximately 50% of prostate cancer patients defined as low and very low risk. Under Medicare rules, the draft LCD is subject to a minimum 45-day public comment period. After comments are considered, a final LCD is issued, which goes into effect after a minimum 45-day notification period.
07:14 EDTMYGNMyriad Genetics sees FY15 EPS $1.90-$2.00, consensus $1.93
Backs FY15 revenue guidance of $800M-$820M, consensus 804.15M.
07:14 EDTMYGNMyriad Genetics sees Q1 adjusted EPS 25c, consensus 41c
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07:00 EDTMYGNMyriad Genetics trading halted, pending news
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October 15, 2014
10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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October 14, 2014
11:23 EDTAZNBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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