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Stock Market & Financial Investment News

News Breaks
May 16, 2014
04:55 EDTVCYT, VCYT, VCYT, VCYT, VCYT, VCYT, AZN, AZN, AZN, AZN, AZN, AZN, INSM, INSM, INSM, INSM, INSM, INSM, ITMN, ITMN, ITMN, ITMN, ITMN, ITMN, XNCR, XNCR, XNCR, XNCR, XNCR, XNCRAmerican Thoracic Society to hold a conference
ATS 2014 San Diego to be held on May 16-21.
News For VCYT;AZN;INSM;ITMN;XNCR From The Last 14 Days
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May 21, 2015
07:37 EDTAZNPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
15:32 EDTVCYTVeracyte reports positive data on company's molecular classifier
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11:51 EDTAZNExpress Scripts' Medco to pay $7.9M to resolve kickback allegations
Medco Health Solutions, a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company (ESRX), of Missouri, has agreed to pay the government $7.9M to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced. Medco provides pharmacy benefit management services to clients who receive subsidies under the Medicare Retiree Drug Subsidy program. The settlement resolves allegations that Medco solicited remuneration from AstraZeneca, a pharmaceutical manufacturer, in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on certain of Medco’s prescription drug lists known as formularies. The United States alleged that Medco received some or all of the remuneration from AstraZeneca in the form of reduced prices on the following AstraZeneca drugs: Prilosec, Toprol XL and Plendil. The United States contended that this kickback arrangement between Medco and AstraZeneca (AZN) violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program. In January 2015, the United States and AstraZeneca reached a $7.9M settlement to resolve kickback allegations arising out of the same conduct. This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, whose share of the settlement has not been determined. The settlement with Medco was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office of the District of Delaware and HHS-OIG.
May 19, 2015
15:05 EDTAZNArdelyx scheduled for end Phase 2 meeting with FDA scheduled in June
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May 18, 2015
10:18 EDTVCYTVeracyte has Percepta market opportunity above $175M, says Piper Jaffray
Following the publication of results from studies that assessed the performance of Veracyte's Percepta test in lung cancer diagnosis, Piper Jaffray said the data was in line with previous diligence and that it expects the NEJM publication to help drive adoption. The firm, which estimates the initial domestic market opportunity for the test at $177M-$236M, kept its Overweight rating and $13 price target on Veracyte shares.
07:10 EDTVCYTVeracyte announces publication of results from two Percepta trials
Veracyte announced online publication in the New England Journal of Medicine of results from two large, prospective, multicenter studies that assessed the clinical performance of the company's Percepta Bronchial Genomic Classifier in lung cancer diagnosis. Findings from the AEGIS I and AEGIS II trials demonstrate the ability of the genomic test to help patients safely avoid unnecessary invasive, risky procedures on suspicious lung nodules or lesions that were initially found on computed tomography, or CT, scans. The AEGIS trials involved 639 patients at 28 sites in the United States, Canada and Ireland who were undergoing bronchoscopy, a common nonsurgical procedure, to assess lung nodules for cancer. Specifically, among patients assessed clinically as having "intermediate" risk of malignancy who then had a non-diagnostic bronchoscopy, the Percepta test had a negative predictive value, or NPV, of 91%, demonstrating the test's ability to reclassify these patients as "low risk" with a high degree of accuracy. The genomic test and the bronchoscopy had a combined sensitivity of 97%, compared to 75% for bronchoscopy alone. The genomic test's specificity was 47% in both studies. The sensitivity of the Percepta classifier alone and in combination with bronchoscopy was consistently high, regardless of nodule size and location, and cancer stage and type.
07:04 EDTVCYTVeracyte announces publication of results from two studies of Percepta
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06:13 EDTAZNAstraZeneca to invest $285M in new biologics manufacturing facility in Sweden
AstraZeneca announced that it plans to invest approximately $285M in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019. Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organisation. By locating the new manufacturing plant in Södertälje, the company will combine its expertise in biologics with the well-established culture of operational excellence that exists within the Sweden Operations unit. The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, Maryland, announced in November.
05:03 EDTVCYTVeracyte Percepta study published in New England Journal of Medicine
Veracyte announced online publication in the New England Journal of Medicine of results from two large, prospective, multicenter studies that assessed the clinical performance of the company's Percepta Bronchial Genomic Classifier in lung cancer diagnosis. Findings from the AEGIS I and AEGIS II trials demonstrate the ability of the genomic test to help patients safely avoid unnecessary invasive, risky procedures on suspicious lung nodules or lesions that were initially found on computed tomography, or CT, scans. The AEGIS trials involved 639 patients at 28 sites in the United States, Canada and Ireland who were undergoing bronchoscopy, a common nonsurgical procedure, to assess lung nodules for cancer. Specifically, among patients assessed clinically as having "intermediate" risk of malignancy who then had a non-diagnostic bronchoscopy, the Percepta test had a negative predictive value, or NPV, of 91%, demonstrating the test's ability to reclassify these patients as "low risk" with a high degree of accuracy. The genomic test and the bronchoscopy had a combined sensitivity of 97%, compared to 75% for bronchoscopy alone. The genomic test's specificity was 47% in both studies. The sensitivity of the Percepta classifier alone and in combination with bronchoscopy was consistently high, regardless of nodule size and location, and cancer stage and type.
May 17, 2015
15:49 EDTAZNAstraZeneca reports Movantik shows 'similar' adverse event rate vs. placebo
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May 15, 2015
09:31 EDTAZN, INSMAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 14, 2015
17:31 EDTXNCRRA Capital reports 7.8% passive stake in Xencor
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16:12 EDTVCYTVeracyte sees FY15 revenue $48M-$53M, consensus $50.62M
Forecasts to achieve annual Afirma GEC test volume in the range of 19,000 to 21,000.
16:12 EDTVCYTVeracyte reports Q1 EPS (34c), consensus (37c)
Reports Q1 revenue $11.2M, consensus $10.83M.
15:01 EDTVCYTNotable companies reporting after market close
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09:22 EDTAZNLeerink pharma/biotech analysts hold an analyst/industry conference call
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05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
17:24 EDTAZNAstraZeneca to update progress with immuno-oncology pipeline at ASCO
AstraZeneca and MedImmune, the company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology, or ASCO, Annual Meeting, May 29-June 2. 61 scientific abstracts will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.
May 12, 2015
17:31 EDTVCYTVeracyte reports publication of Percepta Bronchial Genomic Classifier study
Veracyte announced the online publication of a study on the derivation of the company's Percepta Bronchial Genomic Classifier, which is used to help patients avoid unnecessary invasive procedures as part of lung cancer diagnosis. The article, published in BMC Medical Genomics, details the rigorous scientific and clinical approach used to develop the genomic test. The 23-gene classifier was developed in a dedicated training set of 299 patients enrolled in a large, prospective, multicenter study of current and former cigarette smokers who were undergoing bronchoscopy for lung nodules and lesions that were suspicious for cancer. Subjects were enrolled at 25 medical centers around the country. The classifier's performance in identifying and ruling out cancer was found to be consistent with data from a previously published study. Data from two large prospective, multicenter trials – AEGIS I and AEGIS II – have not yet been published.
May 11, 2015
07:46 EDTINSMInsmed price target raised to $25 from $20 at Cowen
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