The analysts covering Chembio Diagnostics, Inc. (NASDAQ:CEMI) delivered a dose of negativity to shareholders today, by…
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AstraZeneca Plc (AZN) announced on Thursday that the Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted a priority review for its heart treatment Brilinta.The U.S. regulator granted priority review for the drugmaker’s Brilinta (ticagrelor) as a treatment for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA). The FDA action date for the supplemental application, is scheduled for the fourth quarter of 2020.The sNDA was based on results from the Phase III THALES trial, which showed that the treatment of aspirin in combination with Brilinta 90mg dosage used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. The results were in line with the known safety profile of Brilinta.“Patients who have had an acute ischaemic stroke or transient ischemic attack are at high risk of experiencing a subsequent stroke, which may be disabling or fatal,” said Mene Pangalos, Executive VP, BioPharmaceuticals R&D. “Today’s priority review reflects Brilinta’s potential as a much-needed treatment option to reduce the rate of subsequent stroke for these patients and we look forward to working with the FDA to make Brilinta available as soon as possible.”Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.Stroke is the second leading cause of death worldwide, with 6.2 million stroke-related deaths in 2017, of which 2.7 million were due to ischaemic stroke.In May 2020, the FDA approved a label update for Brilinta in the US to include the risk reduction of a first heart attack or stroke in high-risk patients with coronary artery disease.AstraZeneca shares have jumped 43% since mid-March as the company joined the list of companies engaged in the development of a potential coronavirus vaccine. The stock rose 1.4% to close at $54.19 on Wednesday.Despite the recent rally, the $61.67 average analyst price target still puts the upside potential at 14% in the coming 12 months. (See AstraZeneca stock analysis on TipRanks)Overall, the stock scores a Strong Buy consensus from the analyst community based on 4 unanimous Buy ratings.Related News: AstraZeneca-Merck Pancreatic Cancer Drug Wins European Approval Novavax Spikes 42% Pre-Market On $1.6B U.S. Funding For Covid-19 Candidate Corvus Shoots Up 115% On Start Of Novel Immunotherapy Study In Covid-19 Patients More recent articles from Smarter Analyst: * Biogen Files FDA Application For Potential Alzheimer Treatment * Airbus First-Half Deliveries Drop 49% Amid Covid-19 Aviation Crisis * Google Stops Project For Cloud Services In China * Tesla China Sales Of Model 3 Vehicles Up 35% In June
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(Bloomberg) — Walgreens Boots Alliance Inc. plans to cut about 4,000 jobs in the U.K. following a sharp drop in its business there and suspend stock buybacks, as the coronavirus pandemic jolts its business around the world.On Thursday, Deerfield, Illinois-based Walgreens said it anticipates full-year adjusted earnings between $4.65 to $4.75 a share, including $1.03 to $1.14 a share of costs related to Covid-19. Analysts surveyed by Bloomberg were expecting $5.43 a share. Walgreens had previously withdrawn its financial forecasts, citing the turmoil caused by the coronavirus.Drugstores are grappling with both short-term disruptions and potential longer-term changes in consumer behavior driven by Covid-19. Before the pandemic set in, Walgreens was already facing questions about how it planned to compete with rivals focusing on health care and internet giants sizing up the pharmacy business.Now, the playing field has changed once again, as the global spread of Covid-19 continues to alter both the health care and retail industries in unpredictable ways.Shares of Walgreens, which had dropped 28% so far this year through Wednesday, declined as much as 4.9% in premarket trading in New York.Foot traffic plummeted 85% in April at the company’s Boots stores in the U.K. amid strict lockdown orders, resulting in a $700 to $750 million hit to total sales that forced Walgreens to record a $2 billion impairment charge. Overall, sales in the quarter, which ended May 31, were essentially flat compared with the same quarter a year earlier, at $34.6 billion. In the U.S., people rushed to stock up on prescriptions and toilet paper in the early days of the pandemic. Comparable sales at U.S. drugstores rose 3%.Soaring CostsWalgreens said that a broad decline in visits to doctors’ offices and hospitals weighed on prescription volumes. Prescriptions filled at its U.S. drugstores fell 1.3% compared with the year-ago quarter, though volumes have shown “steady improvement” since the end of May.Costs associated with cleaning stores and boosting employee pay sent selling, general and administrative expenses soaring to $8.3 billion in the quarter from $6.2 billion in the year-ago quarter.To help expand its health-care offerings, Walgreens said Wednesday it plans to open as many as 700 doctors’ offices in its drugstores over the next five years. Rival CVS Health Corp. has already made big steps in that direction by buying insurer Aetna and making over stores to focus on patient care.Walgreens posted a loss of $1.71 billion, or $1.95 a share, in the fiscal third quarter. On an adjusted basis, earnings per share came to 83 cents. Analysts surveyed by Bloomberg expected adjusted earnings of $1.19 a share.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
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We know that hedge funds generate strong, risk-adjusted returns over the long run, which is why imitating the picks that they are collectively bullish on can be a profitable strategy for retail investors. With billions of dollars in assets, professional investors have to conduct complex analyses, spend many resources and use tools that are not […]
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Aston Martin’s first sport utility vehicle rolled off the production line on Thursday, key to hopes of a turnaround at the luxury carmaker which has seen changes in management and ownership over the last few months amid a torrid performance. Popular for being James Bond’s carmaker of choice, the firm has had a difficult time since it floated in 2018 as sales disappointed and it burnt through cash, prompting it to seek fresh investment from billionaire Lawrence Stroll. The DBX vehicle is the company’s first foray into the lucrative sport utility vehicle market, a late entrant compared to many rivals such as Volkswagen-owned Bentley and BMW’s Rolls-Royce.
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Biogen Inc. (BIIB) announced that it has finally submitted the Biologics License Application (BLA) seeking approval by the Food and Drug Administration (FDA) for aducanumab, its investigational treatment for Alzheimer’s disease.If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease, the company said. The FDA application submission had been delayed since early 2020. Aducanumab is a human monoclonal antibody designed to treat early Alzheimer’s disease.Biogen said that the completed submission followed ongoing collaboration with the FDA and includes clinical data from the Phase 3 studies, as well as the Phase 1b study.“Alzheimer’s disease remains one of the greatest public health challenges of our time,” said Biogen CEO Michel Vounatsos. “The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease.”Biogen reported that clinical studies showed that patients who received aducanumab experienced significant slowing of decline on measures of cognition and function such as memory, orientation and language. Patients also experienced slowing of decline on activities of daily living including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home.The FDA now has up to 60 days to decide whether to accept the application for review. As part of the submission, Biogen requested to get priority review.The stock rose 4.4% on the news and closed at $280.19 on Wednesday trimming this year’s decline to 5.6%. Meanwhile some analysts are skeptical about the likelihood of the drug approval. Although, Goldman Sachs analyst Terence Flynn called Biogen's submission “an important first step and incremental positive," he seeks risk to its approval.“The central question is how the FDA will interpret the aducanumab Phase 3 data given a single positive trial, weighed against the unmet need in Alzheimer's”, Flynn wrote in a note to investors adding that he sees a 20% probability of success.The analyst maintained a Hold rating on the stock with a $300 price target (7.1% upside potential).In line with Flynn’s outlook, Wall Street analysts have a Hold consensus on Biogen with a $312.16 average price target (11% upside potential). In the last three months, the stock has received 13 Hold ratings and 4 Sell ratings versus 8 Buy ratings. (See BIIB stock analysis on TipRanks).Related News: Novavax Spikes 42% Pre-Market On $1.6B U.S. Funding For Covid-19 Candidate Corvus Shoots Up 115% On Start Of Novel Immunotherapy Study In Covid-19 Patients GenMark Soaring In Pre-Market On 118% Revenue Explosion More recent articles from Smarter Analyst: * Airbus First-Half Deliveries Drop 49% Amid Covid-19 Aviation Crisis * Google Stops Project For Cloud Services In China * Square (SQ): One Analyst Finally Got off the Fence — but for What? * Google Vulnerable to Reduced Ad Spend, Says 5-Star Analyst
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German state prosecutors are investigating Wirecard for suspected money laundering, a spokeswoman for the Munich prosecutor’s office said on Thursday. “We are investigating suspected money laundering,” the spokeswoman told Reuters, saying the inquiry was directed at individuals from Wirecard. Wirecard declined to comment.
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