|Bid||51.34 x 1300|
|Ask||51.41 x 3200|
|Day's Range||51.16 - 51.55|
|52 Week Range||35.30 - 51.55|
|Beta (5Y Monthly)||0.20|
|PE Ratio (TTM)||64.40|
|Forward Dividend & Yield||1.40 (2.77%)|
|Ex-Dividend Date||Aug 06, 2019|
|1y Target Est||52.92|
Global pharmaceutical majors and generic drugmakers chopped by 53% on average prices of some of their off-patent products in the latest bidding round under China's national bulk-buy program, government officials said late on Friday. Beijing has been pushing forward the program where drugmakers have to go through a bidding process and cut prices low enough to be considered over generic copies and be allowed to sell their products at public hospitals via large-volume government procurement. Some global firms such as AstraZeneca and Merck have already cautioned about intensifying price pressures on their mature brands in the world's second largest drug market, as China expands the usage of the program.
Acasti Pharma (NASDAQ:ACST) is a classic example of the extreme volatility of small-cap biotech stocks. It was only in late December that the shares were fetching $2.87, up from $1 a year earlier. But now ACST stock is trading around 79 cents, with a market cap of about $70 million. To provide some context, in 2013 the shares were trading around $40.Source: Shutterstock Founded in 2002, Acasti specializes in developing prescription drugs that use omega-3 fatty acids derived from krill oil. Keep in mind that those acids have been shown to effectively reduce triglycerides, thereby helping to make people's hearts healthier.The problem is that the underlying science is extremely complex and challenging. That was certainly highlighted recently when Acasti received disappointing results from a Phase 3 clinical trial of its CaPre drug. The drug was supposed to treat patients who suffer from severe hypertriglyceridemia, in which triglyceride blood levels range from 500 mg/dL to 1500 mg/dL.InvestorPlace - Stock Market News, Stock Advice & Trading TipsAs for the trial, it did have some positive outcomes. For example, the drug produced a 30.5% median reduction in triglyceride levels over a 12-week term. The median triglyceride reduction of patients taking the drug in combination with a statin was 42.2%, versus a 31.5% median reduction for those taking a placebo and a statin.So what went wrong? According to Acasti's press release: "Both the placebo and CaPre study groups experienced significant reductions in triglycerides within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, TRILOGY 1 did not reach statistical significance." * The Top 5 Dow Jones Stocks to Buy for 2020 Despite this setback, Acasti is not giving up. The company is analyzing the data to determine the reasons for the endpoint miss. The remaining top-line data from the trial will be released in the next couple of weeks, and the FDA is expected to issue more analysis about the secondary endpoints of the trial within the next couple months. Additional positive data could emerge, boosting ACST stock.But I think investors should be extremely cautious about ACST. Just look at AstraZeneca (NYSE:AZN), whose fish-derived heart drug Epanova also failed to meet its primary endpoint in a clinical trial. In fact, the company decided to stop developing the drug, resulting in a $100 million writeoff. The Bottom Line on ACST StockACST is all about CaPre. So if the drug is not progressing sufficiently, the company's prospects will certainly be ominous.It's also important to point out that Acasti's rival, Amarin (NASDAQ:AMRN), is continuing to make headway with its fish-oil drug, Vascepa. During the latest reported quarter, Vascepa's sales soared 103% year-over-year to $112.4 million. That will definitely make things tougher on ACST.Also, consider that Amarin recently received FDA approval for an expanded indication for Vascepa. The drug was shown to be effective for patients who have elevated triglyceride levels of ≥150 mg/dL. According to Dr. Deepak Bhatt, an executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, the treatment "represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins…"Vascepa's annual sales could reach $4 billion within the next three or four years. In other words, for investors looking for a play on the cardiovascular market, Amarin looks like a pretty good option, while ACST stock looks like a name that they should avoid.Tom Taulli is the author of the book, Artificial Intelligence Basics: A Non-Technical Introduction. Follow him on Twitter at @ttaulli. As of this writing, he did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * The Top 5 Dow Jones Stocks to Buy for 2020 * 7 Fintech ETFs to Buy Now for Fabulous Financial Exposure * 3 Tech Stocks to Play Ahead of Earnings The post Does Acasti Stock Have a Future? appeared first on InvestorPlace.
Amarin (NASDAQ:AMRN) stock has been choppy for the past year, as the price has made multiple attempts to move above the $23-$24 range. However, this has been a stubborn line of resistance, considering the stock price is currently around $20.Source: Pavel Kapysh / Shutterstock.com Despite this, Amarin stock has still been a pretty good bet over the years. After all, the five-year average return is close to 80%.So, what now? Could there be an opportunity with Amarin stock? Well, I think so.InvestorPlace - Stock Market News, Stock Advice & Trading TipsTo see why, let's get a brief backgrounder on the company. Founded in 1993, Amarin is one of the leaders in leveraging lipid science and polyunsaturated fatty acids to create pharmaceuticals to improve heart health. The main drug is Vascepa, which has posted robust growth. In the latest quarter, revenues hit $112.4 million, up 103% on a year-over-year basis. This has been due to substantial increases in the number of subscribers and higher levels of prescriptions per prescriber. * 10 Cheap Stocks to Buy Under $10 However, the key for Amarin is that it recently gained FDA approval for wider applications for Vascepa. This decision, ironically enough, came on Friday the 13th last month -- but of course, this really should be a very lucky day. Vascepa's DevelopmentThe new indication and label expansion -- which is the result of a decade of research and development -- is for a therapy to reduce "the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease."Yes, this is kind of medical jargon. But when boiling things down, the new use for Vascepa is a game changer.According to Dr. Deepak Bhatt, an executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, the treatment "represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins…"The market opportunity is enormous, as there -- on average -- one cardiovascular death occurring every 40 seconds in the U.S. Also, the financial costs of cardiovascular disease events are burdensome at about $500 billion a year -- the most costly in the U.S. The CompetitionThere are a myriad of companies trying to do what Amarin has done; that is, using lipid therapies for cardiovascular disease. But, the science has proven quite complex and challenging.Note that there have been some recent examples of Phase 3 trials that shown disappointing results, such as from AstraZeneca (NYSE:AZN) and Acasti Pharma (NASDAQ:ACST). In fact, since December, ACST has plunged from $2.87 to around $0.80 per share.In fact, Cantor Fitzgerald analyst Louise Chen recently wrote after these companies' failures that "AMRN has been the only company in its class with an outcomes study (REDUCE-IT) that has shown a statistically significant benefit in reducing [cardiovascular] disease. We think the news today underscores our view that AMRN is an interesting asset in a consolidating space." Bottom Line On Amarin StockLast week, Amarin issued revised guidance for 2019. Revenues are now expected to range from $410 million to $425 million, which is at or slightly above the upper end of the prior forecast. The company also noted that beyond 2020, Vascepa's total net revenue "will grow to reach multiple billions of dollars" because "the history of other therapies for chronic conditions suggests that growth builds over multiple years."Given this, the growth story should be robust for quite some time. This should also stir up mergers & acquisitions interest from the mega pharma companies like Pfizer (NYSE:PFE), Merck (NYSE:MRK) and even AZN.Let's face it, they need to fill their pipelines with blockbuster drugs -- and these companies certainly have the resources to pay a premium price for Amarin.Tom Taulli is the author of the book, Artificial Intelligence Basics: A Non-Technical Introduction. Follow him on Twitter at @ttaulli. As of this writing, he did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Cheap Stocks to Buy Under $10 * 5 Retail Stocks Placer.ai Thinks Can Win Big in 2020 * 6 Cheap Stocks to Buy Under $7 The post Why Amarin Stock Is Poised for a Healthy 2020 appeared first on InvestorPlace.
Clovis' (CLVS) sNDA seeking label expansion of Rubraca to include BRCA-mutant advance prostate cancer gets priority review from the FDA. Stock up.
Under the deal, inked in November 2018, NextCure gave Eli Lilly access to its proprietary platform for research aimed at developing and commercializing new cancer therapies.
The seller converted the office space — leased heavily by local biotech companies — to lab suites, then sold the buildings just three years after buying them.
AstraZeneca (AZN) to discontinue STRENGTH study on its fish-oil pill Epanova in mixed dyslipidaemia on recommendation of an independent Data Monitoring Committee
Amarin stock popped Monday after rivals AstraZeneca and Acasti Pharma reported disappointing outcomes for their Vascepa-rivaling high triglycerides treatments.
Shares of Amarin Corp. PLC rose 4.8% in active afternoon trading Monday, after makers of drugs that rival Amarin's Vascepa, which is used to lower the risk of cardiovascular events in patients with high triglyceride levels reported disappointing trial results. Trading volume in Amarin's stock was 13.6 million shares, well above the full-day average of about 9.9 million shares. Acasti Pharma Inc. said a phase 3 trial of CaPre failed to meets its primary endpoint, of reducing triglycerides by 20% compared with placebo. The median triglyceride reduction in patients taking CaPre was 30.5% while the median reduction of patients taking a placebo was 27.5%. Acasti's stock plummeted 64% on volume of 48 million shares. And AstraZeneca PLC shares fell 0.6% said it would discontinue the phase 3 trial of Epanova given its "low likelihood of demonstrating a benefit" to patients at increased risk of cardiovascular events, and that it would take a charge of up to $100 million as a result. Amarin's stock has run up 30.5% over the past three months, while the S&P 500 has gained 10.5%.
AstraZeneca and Acasti Pharma each disclosed disappointing results from cardiovascular drugs derived from fish or krill oil.
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AstraZeneca will take a $100m writedown after trials of a heart disease drug showed it to be ineffective in treating a particular cardiovascular condition. After the disappointing results, the pharmaceutical group said it would discontinue trials on the drug, known as Epanova, and carry out a review into its $533m value on the company’s balance sheet. Epanova is used in the US to treat a condition involving high levels of triglycerides in the bloodstream that can be a forerunner of heart disease.
(Bloomberg) -- Want the lowdown on European markets? In your inbox before the open, every day. Sign up here.AstraZeneca Plc will stop testing a fish-oil pill for a form of harmful cholesterol that was in the most advanced and expensive stage of clinical trials.The medicine, called Epanova, didn’t stand a very high likelihood of showing a benefit when combined with a statin for patients at risk of heart disease due to high levels of LDL (or bad) cholesterol, Astra said in a statement Monday.Epanova, gained in Astra’s 2013 takeover of Omthera Pharmaceuticals, is a prescription omega-3 capsule approved to treat high levels of triglycerides, which also clog up patients’ arteries. Fish oils contain fatty acids that help combat deposits in blood vessels.“Epanova would have rounded out Astra’s growing suite of differentiated cardiovascular disease assets,” Andrew Baum, an analyst at Citi, wrote in a note to clients. He cited medicines such as Brilinta for heart disease, Farxiga, a diabetes drug that’s also approved for heart failure, and roxadustat, an anemia treatment.A write-down of as much as $100 million related to inventories will impact core earnings in the fourth quarter of 2019, Astra said. The company will review the drug’s $533 million value as an intangible asset. Astra shares were little changed in London.The failure is “a disappointment,” but isn’t having much impact on the stock because the drug’s estimated contribution to future sales was modest, according to Citi’s Baum. Analysts surveyed by Bloomberg expected the medicine to generate peak revenue of $145 million in 2023.(Updates with analyst’s comment in fourth paragraph)To contact the reporters on this story: Marthe Fourcade in Paris at firstname.lastname@example.org;Erin Roman in London at email@example.comTo contact the editors responsible for this story: Eric Pfanner at firstname.lastname@example.org, John LauermanFor more articles like this, please visit us at bloomberg.com©2020 Bloomberg L.P.
AstraZeneca PLC said Monday that it will discontinue the trial for the drug Epanova following a recommendation from an independent data-monitoring committee.
What's next for Amarin (NASDAQ:AMRN) stock? After the Food and Drug Administration (FDA) expanded the label for its flagship Vascepa drug, Amarin stock could rally tremendously in the coming years. Even before the FDA ruling, Vascepa's sales were surging fast. Analysts, on average, predict that Vascepa generated between $410 million and $425 million of sales in 2019. That's an 85% jump versus 2018!Sales of Vascepa are also set to climb this year, thanks to the expanded label. According to SVB Leerink's Ami Fadia, Vascepa could reach peak sales of $4 billion-plus a year. Source: Pavel Kapysh / Shutterstock.com But since December, the AMRN stock price has dipped from its 52-week high. The shares peaked at $26.12 on Dec. 16, but now trade under $20 per share. Why are investors cashing out, even though Vascepa is poised to become a blockbuster drug?InvestorPlace - Stock Market News, Stock Advice & Trading TipsSome remain skeptical as to whether Vascepa will live up to the hype. As InvestorPlace columnist Josh Enomoto wrote in a Jan. 3 column,Vascepa is an "adjunctive treatment option." In other words, it's not a "cure all" for cardiovascular disease.Also, competition could impact Vascepa's sales, and in turn, Amarin stock. AstraZeneca (NYSE:AZN) has its own cardiovascular treatment in the pipeline, as does Acasti Pharma (NASDAQ:ACST). * The Top 15 Stocks to Buy in 2020 Upcoming litigation could also impact the AMRN stock price. Amarin is fighting patent challenges from several generic drug makers. With these factors in mind, let's dive in and see whether Amarin stock will rise or fall in 2020. Will Vascepa Make Amarin Stock a Takeover Target?After the label for Vascepa was expanded, big pharma may want to get their hands on this potential blockbuster. As I've previously discussed, Pfizer (NYSE:PFE) is shedding legacy businesses to chase growth opportunities. Acquisitions of smaller biopharma companies like Amarin are key to this strategy.For big pharma, M&A is cheaper than R&D. InvestorPlace contributor Dana Blakenhorn recently cited a FiercePharma article which listed a grab bag of potential AMRN acquirers. But according to the FiercePharma piece, Amarin isn't looking to "cash the check" i.e. sell itself. Instead, AMRN is going it alone, increasing its sales force via 800 new hires.That strategy makes the outlook of AMRN stock price more uncertain. But Amarin may not be such a hot takeover target. InvestorPlace columnist Vince Martin pointed out in December why AMRN may not be at the top of big pharma's shopping list.According to Martin, cardiovascular drugs are rarely blockbusters. Big pharma is more interested in acquiring companies with oncology and CAR-T treatments in the pipeline. That is where major pharma names are fishing at the moment.There are good reasons, however, why Amarin stock could become a takeover target. Conversely, there are good reasons why buyers may not pay a big premium to get their hands on Vascepa. So investors should not buy AMRN stock based on this factor alone. Patent Litigation Could Impact the AMRN Stock PriceVascepa may be having its day in the sun. But what if AstraZeneca or Acasti Pharma develops a better treatment, potentially leaving Vascepa in the dust? Also, Amarin is fighting off generic drug makers' attempts to market generic versions of Vascepa.Vascepa is under patent protection until 2030. But that hasn't stopped Dr. Reddy's (NYSE:RDY), Hikma Pharmaceuticals (OTCMKTS:HKMPF) and Teva (NYSE:TEVA) from challenging its patents. Amarin previously settled with Teva, allowing the Israeli firm to sell a generic version of Vascepa in 2029.But Dr. Reddy's and Hikma want to duke it out in court. Amarin's lawsuit is slated to go to trial on Jan. 13. The fate of the company's patents could impact the AMRN stock price.What are the chances of Amarin prevailing? The prior Teva settlement may tilt things in Amarin's favor. But no matter the outcome, AMRN stock price could rise either way. Investors could already be pricing litigation risk into the shares, and eliminating that overhang will be positive for Amarin stock.A favorable ruling would be icing on the cake. By protecting Vascepa's patents until 2029 (when Teva will release its generic version), a favorable ruling would make Amarin's crown jewel a more valuable asset to a strategic acquirer. The Bottom Line: All Bets Are Off For Amarin Stock in 2020After its big moves in 2019, Amarin stock may already be fairly priced. But if the company's sales climb meaningfully, AMRN stock price could go higher. While the company is willing to "go it alone," a strategic acquirer could offer a hefty premium to add this drug to its pipeline.But Amarin stock is not a slam dunk going forward. Competing drugs could leave Vascepa in the dust. If Dr. Reddy's and Hikma Pharmaceuticals prevail in court, generic versions of Vascepa could hit shelves sooner than anticipated.With these uncertainties in mind, tread carefully with Amarin stock. Consider it a buy if the shares dip further, but don't chase this potential takeover target.As of this writing, Thomas Niel did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * The Top 15 Stocks to Buy in 2020 * The 7 Most Important Companies That Didn't Survive the 2010s * 4 Mega-Tech Stocks Reaching for the Sky The post All Bets Are Off for Amarin Stock appeared first on InvestorPlace.
Pfizer (PFE) and Merck KGaA's Bavencio meets the primary goal in a late-stage study evaluating it as a first-line maintenance therapy for metastatic urothelial carcinoma, a form of bladder cancer.
Bank of America expects European stocks broadly to rise this year, but its key underweight call is the pharmaceutical sector, and the recommendation has nothing to do with talk of reining in U.S. drug prices.
The stock was static in 2019, but a Wall Street veteran thinks investors are overlooking the company's outstanding pipeline and strong upward momentum Continue reading...
J.P. Morgan’s Richard Vosser upgraded (SAN)(ticker: SAN.France) to Overweight from Neutral, and named (ROG)(ROG.Switzerland), (NOVO-B)(NOVOB.Copenhagen), and (AZN)(AZN) as top picks. As for Galapagos, Vosser downgraded the stock to Neutral after its blockbuster 2019.
AstraZeneca (AZN) gets the FDA's priority review status for its sNDA seeking label expansion of Farxiga for patients with heart failure with reduced ejection fraction.
AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).