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News Breaks
April 7, 2014
05:48 EDTAZN, MYGNMyriad Genetics submits premarket approval to FDA for BRACAnalysis
Myriad Genetics (MYGN) announced that it has submitted the first module of a premarket approval, or PMA, application to the FDA for the use of BRACAnalysis testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase, or PARP, inhibitor being developed by AstraZeneca (AZN).
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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March 13, 2015
11:45 EDTMYGNMyriad Genetics management to meet with Stephens
Meeting to be held in Portland, Oregon on March 17-18 hosted by Stephens.
11:19 EDTAZNBioMarin rallies amid positive call on DMD drug timeline, takeover rumor
The shares of drug maker BioMarin (BMRN) are climbing after research firm Jefferies quoted a regulatory expert as saying that the company's drisapersen drug has a good chance of being approved on an accelerated basis by the FDA. Drisapersen is a treatment for Duchenne Muscular Dystrophy, or DMD. WHAT'S NEW: "There is a strong possibility" that the FDA will grant accelerated approval to drisapersen because there is currently no approved drug for the treatment of DMD, Jefferies analyst Eun Yang quoted the expert as saying. The expert is also optimistic about the outlook for accelerated approval because she had a good experience working with BioMarin while she was with the FDA and because BioMarin has a favorable track record with the FDA, according to Yang. There is a 60% chance that drisapersen will be approved by the end of this year and the stock can rise to $155, versus its current level of about $121.50, if that does occur, the analyst stated. Yang's price target on the stock increased to $135 from $125 and the analyst kept a Buy rating on the shares. WHAT'S NOTABLE: Pharmaceutical giant AstraZeneca (AZN) has been rumored to be interested in buying BioMarin for $175 per share in cash, British newspaper Daily Mail reported. , Piper Jaffray analyst Joshua Schimmer wrote in a note to investors this morning that BioMarin, along with Vertex (VRTX) and Incyte (INCY), have a "clear path" to joining the group of companies with market caps of over $10B projected to deliver greater than 20% EPS CAGR, which the analyst identified as a set of criteria that has previously pointed to companies that make good potential takeover targets. PRICE ACTION: In mid-morning trading, BioMarin climbed nearly 4% to $120.
09:49 EDTMYGNUBS life science tools/diagnostics analyst has analyst/industry conference call
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08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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