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LON100:AZN, Jan 18, 02:47 UTC

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Tuesday, January 14


News

AstraZeneca to End Phase III Study on Fish Oil Heart Drug

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ZacksJanuary 14, 2020, 2:46 PM UTC. AstraZeneca plc AZN announced plans to discontinue a late-stage outcomes study evaluating its cholesterol medicine, Epanova to reduce the risk of cardiovascular disease in patients with mixed dyslipidaemia (MDL) or high triglyceride (TG) levels. Epanova, a fish oil derived tablet, is presently marketed in the United States as an adjunct to diet to reduce TG levels in adult patients with severe hypertriglyceridemia. If the STRENGTH study would have been successful and Epanova was subsequently approved for the CV indication, it would have broadened the drug’s label and made it eligible to treat an expanded patient population and thereby bring in higher sales. AstraZeneca said it would take a charge of up to $100 million related to inventories, which will hurt its earnings in the fourth quarter. Meanwhile, another company, Acasti Pharma ACST announced that a phase III study evaluating its krill oil derived candidate CaPre for the treatment of severe hypertriglyceridemia failed to reach statistical significance for the primary endpoint of reducing triglycerides by 20%. Acasti's stock plummeted 65% on Monday in response. However, gaining from AstraZeneca and Acasti’s failures, shares of Amarin Corporation AMRN were up 4.2% on Monday as its fish-oil derived drug Vascepa was approved to lower CV risk in patients with high triglyceride levels late last year.

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Monday, January 13


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Good News for Amarin: AstraZeneca Abandoning its Fish Oil Pill

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Good News for Amarin: AstraZeneca Abandoning its Fish Oil Pill | NASDAQ. AstraZeneca(NYSE: AZN) announced on Monday that it was discontinuing the phase 3 Strength clinical study evaluating Epanova in reducing cardiovascular risk. The British drugmaker said that the decision was made after the study's independent data monitoring committee determined that there was a "low likelihood" that Epanova would help patients with mixed dyslipidemia (MDL) who are at risk of cardiovascular disease. Epanova won U.S. Food and Drug Administration (FDA) approval in 2014 for treating adult patients with severe hypertriglyceridemia, a condition where patients have triglyceride levels of at least 500 mg/dL. AstraZeneca picked up the drug in 2013 with its acquisition of Omthera Pharmaceuticals. The drug's sales were never high enough to even warrant a mention in any of AstraZeneca's annual regulatory filings. AstraZeneca undertook the large-scale Strength study in hopes that it could position Epanova as a drug that could reduce cardiovascular risk.

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AstraZeneca plc (AZN) vs. Top 20 Hedge Fund Stocks in 2019

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The huge amount of capital does not allow hedge funds to invest a lot in small-caps, but our research showed that their most popular small-cap ideas are less efficiently priced and generate stronger returns than their large- and mega-cap picks and the broader market. In this article, we look at what those funds think of AstraZeneca plc (NYSE:AZN) based on that data. AstraZeneca plc (NYSE:AZN) investors should be aware of an increase in activity from the world's largest hedge funds in recent months. Our calculations also showed that AZN isn't among the 30 most popular stocks among hedge funds (click for Q3 rankings and see the video at the end of this article for Q2 rankings). Below, you can check out the change in hedge fund sentiment towards AZN over the last 17 quarters. So, let's see which hedge funds were among the top holders of the stock and which hedge funds were making big moves.

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AstraZeneca to discontinue Epanova trial, expects $100 mln writedown

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Jan 13 (Reuters) - AstraZeneca AZN.L said on Monday it will discontinue a late-stage trial for heart disease drug Epanova to treat patients with mixed dyslipidaemia and expects a $100 million writedown to hit its core profit in the fourth quarter. The biggest British drugmaker by market value said the decision, which followed recommendations from an independent data monitoring committee, was due to low likelihood of Epanova's benefit to patients with mixed dyslipidaemia. Mixed dyslipidaemia is characterized by abnormal levels of cholesterol and fatty substances in the blood known as triglycerides. AstraZeneca added Epanova, which is is already approved in the United States to reduce high levels of triglyceride, to its pipeline when it bought U.S.-based Omthera Pharmaceuticals in 2013 to build up its cardiovascular drug business. In a separate statement, AstraZeneca and Merck MRK.N said their ovarian cancer drug Lynparza, in combination with bevacizumab, has been granted priority review status in the U.S. and a decision on its approval is set for the second quarter this year.

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Tuesday, January 07


News

MiNA Therapeutics Announces Research Collaboration with AstraZeneca in Metabolic Diseases

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“Many metabolic diseases lack sufficient treatment options to help patients manage their disease and to treat the underlying causes to improve patient outcomes. This is an exciting opportunity for us to collaborate with AstraZeneca, a global leader in the discovery and development of prescription medicines to treat metabolic diseases, that may lead to therapeutic advances for a large number of patients globally,” said Robert Habib, CEO of MiNA. Under the terms of the agreement MiNA and AstraZeneca will conduct in vitro and in vivo studies that may enable the future development of saRNA therapeutics to treat metabolic diseases through biological pathways not addressable by conventional treatment strategies. Upon completion of these studies, AstraZeneca will have the option to negotiate a license agreement to further develop saRNA molecules that activate an undisclosed gene target identified by AstraZeneca.

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Monday, January 06


News

AstraZeneca's Farxiga sNDA Gets Priority Review Status by FDA

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AZN announced that the FDA accepted a supplemental new drug application (sNDA) for its SGLT2 inhibitor Farxiga (dapagliflozin) and granted priority review to the same. The blockbuster drug, approved to treat T2D, is being evaluated in two phase III studies — DAPA-HF and DELIVER — to see its effect on adults suffering from heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively. The sNDA was based on positive results from the DAPA-HF study on Farxiga. All these studies are part of AstraZeneca's DapaCare clinical program, exploring the CV, metabolic and renal profile of Farxiga in T2D patients.

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I think the AstraZeneca share price could be in for another great decade

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I think the AstraZeneca share price could be in for another great decade. Despite a few weak years when AstraZeneca (LSE:AZN) was struggling, its share price has soared by 160% over the past 10 years, easily beating the FTSE 100‘s 45% rise. That certainly wasn’t a surprise, and wouldn’t have had such a big impact if the company had been investing sufficiently in its drug development pipeline to produce a stream of new candidates. But it hadn’t been doing that, and had diversified into all sorts of retail medical-related products (where it didn’t really have any significant competitive advantage). The turnaround started with the appointment of Pascal Soriot as the firm’s new chief executive in 2012, with the share price starting its climb a year later. Soriot’s turnaround plan included the disposal of the firm’s non-core businesses, and a renewed focus on research and development.

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Friday, January 03


News

BMY or AZN: Which Is the Better Value Stock Right Now?

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We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. This system places an emphasis on companies that have seen positive earnings estimate revisions, so investors should feel comfortable knowing that BMY is likely seeing its earnings outlook improve to a greater extent. But this is only part of the picture for value investors. Value investors are also interested in a number of tried-and-true valuation metrics that help show when a company is undervalued at its current share price levels. These are just a few of the metrics contributing to BMY's Value grade of A and AZN's Value grade of C. BMY has seen stronger estimate revision activity and sports more attractive valuation metrics than AZN, so it seems like value investors will conclude that BMY is the superior option right now.

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Wednesday, January 01


News

Will this news give the AstraZeneca share price a shot in the arm?

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Will this news give the AstraZeneca share price a shot in the arm? Its drug Lynparza (olaparib) – which it has co-developed and co-commercialised with Merck (known as MSD outside of the US and Canada) – received regulatory approval for the treatment of pancreatic cancer. With this approval, the drug – which was already in use for treating multiple forms of cancer – creates a niche in cancer treatment. On the collaboration, Chief Executive Officer of AstraZeneca Pascal Soriot had said “By bringing together the expertise of two leading oncology innovators, we will accelerate Lynparza’s potential to become the preferred backbone of many immuno-oncology combination therapies as the world’s first and leading PARP inhibitor.”. As part of the collaboration agreement, Merck had decided to pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options and up to $6.15 billion depending upon successful achievement of future regulatory and sales milestones. What does this approval mean for investors? AstraZeneca stock has had an excellent 2019. Until December 30, its share price had increased by 31.5% for the year.

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Tuesday, December 31


News

AstraZeneca's Lynparza Gets FDA Nod for Pancreatic Cancer

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ZacksDecember 31, 2019, 1:55 PM UTC. AstraZeneca AZN and Merck MRK announced that the FDA has approved their PARP inhibitor, Lynparza, as maintenance treatment for BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) in patients whose disease has progressed at least 16 weeks following first-line platinum-based chemotherapy regimen. With this approval, Lynparza becomes the first PARP inhibitor to be approved for treating biomarker-selected patients with advanced pancreatic cancer. In the first nine months, sales from the drug grew 93% year over year to $847 million on the back of several label expansions, especially first-line ovarian cancer. AstraZeneca expects it to reach blockbuster status this year. Lynparza enjoys advantage in the PARP inhibitor segment as it is approved for the most number of oncology indications. AstraZeneca PLC Price. AstraZeneca PLC price | AstraZeneca PLC Quote.

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