ACST - Acasti Pharma Inc.

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
0.7770
-0.0381 (-4.67%)
At close: 4:00PM EST
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Previous Close0.8151
Open0.8000
Bid0.7750 x 900
Ask0.7790 x 900
Day's Range0.7700 - 0.8100
52 Week Range0.5100 - 3.0800
Volume3,565,773
Avg. Volume4,377,461
Market Cap66.861M
Beta (5Y Monthly)0.41
PE Ratio (TTM)N/A
EPS (TTM)-1.2240
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est2.52
  • Does Acasti Stock Have a Future?
    InvestorPlace

    Does Acasti Stock Have a Future?

    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.

  • Why Amarin Stock Is Poised for a Healthy 2020
    InvestorPlace

    Why Amarin Stock Is Poised for a Healthy 2020

    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.

  • AstraZeneca to End Phase III Study on Fish Oil Heart Drug
    Zacks

    AstraZeneca to End Phase III Study on Fish Oil Heart Drug

    AstraZeneca (AZN) to discontinue STRENGTH study on its fish-oil pill Epanova in mixed dyslipidaemia on recommendation of an independent Data Monitoring Committee

  • Benzinga

    The Daily Biotech Pulse: PhaseBio To Buy Hypertension Asset, Stemline Falls On Q4 Pre-Announcement, FDA Panel To Review Nektar's Opioid Drug

    The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 13.) Arvinas Inc (NASDAQ: ARVN ) Baxter International ...

  • This Biotech Stock Is Flying High After Rival Heart Drugs Stumbled
    Investor's Business Daily

    This Biotech Stock Is Flying High After Rival Heart Drugs Stumbled

    Amarin stock popped Monday after rivals AstraZeneca and Acasti Pharma reported disappointing outcomes for their Vascepa-rivaling high triglycerides treatments.

  • MarketWatch

    Amarin's stock surges, as rival drugs from AstraZeneca, Acasti disappoint

    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%.

  • CNW Group

    Neptune Provides Updates on Non-Core Investments

    LAVAL, QC , Jan. 13, 2020 /CNW Telbec/ - Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NEPT) (NEPT), a health and wellness company focused on extraction, purification and formulation of cannabinoids, would like to provide an update on its non-core investments. In recent months, Neptune sold 1,964,695 shares of Acasti Pharma Inc. (ACST) for net proceeds of US$4 million as part of a monetizing process for the Company's non-core investments. Neptune still owns 1 million shares in Acasti.

  • Barrons.com

    Amarin Stock Is Surging as Rival Makers of Fish-Oil Heart Drugs Fall Short

    AstraZeneca and Acasti Pharma each disclosed disappointing results from cardiovascular drugs derived from fish or krill oil.

  • GlobeNewswire

    Acasti Pharma Reports Topline Results for TRILOGY 1 Phase 3 Trial of CaPre

    Reports 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in.

  • All Bets Are Off for Amarin Stock
    InvestorPlace

    All Bets Are Off for Amarin Stock

    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.

  • 3 Healthcare Stocks With Big Catalysts in January
    TipRanks

    3 Healthcare Stocks With Big Catalysts in January

    When searching for the stocks that can see explosive growth overnight, look no further than the healthcare industry. Unlike other names, healthcare companies often rely on only a few key milestones like data readouts or FDA approvals. So, when a particular result goes a company’s way, the news can act as a catalyst that sends shares soaring. However, investors looking to gain exposure to this space should know that this also makes these stocks riskier as unfavorable outcomes can have the opposite effect.As a result, the strength of investment opportunities in this sector can be harder to determine. So what’s the best way to gauge healthcare stocks ahead of big catalysts? We suggest turning to Wall Street analysts for guidance.Using TipRanks, an investing platform that measures and tracks the performance of analysts, we were able to access market data on 3 stocks as they approach significant catalysts this month, including what the analysts have to say about each. The platform also revealed that all of these Strong Buy tickers boast impressive upside potential from current levels. Here’s the diagnosis.Acasti Pharma (ACST)Like headline-making biotech Amarin, Acasti Pharma focuses on the development and commercialization of prescription drugs using omega-3 fatty acids. The company’s lead candidate, CaPre, is currently progressing through a Phase 3 program for severe hypertriglyceridemia, a condition that leads to abnormally high levels of triglycerides in the bloodstream. With new CaPre TRILOGY 1 and 2 trial data expected this month, all eyes are on ACST.While top-line data from the TRILOGY 1 trial was originally slated for December, the company had to delay the readout as a result of a delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation. Even though the delay was technical in nature, some investors were not impressed.That being said, Oppenheimer analyst Leland Gershell remains unphased. “With the complex logistics and enormity of work required of several people to process Phase 3 trial results bumping up against the holidays and their attendant slowdown, we are not surprised to learn that the report of top-line data from CaPre's TRILOGY 1 will slip past December… Our expectation for a positive trial outcome is unchanged, and we recommend investors take advantage of the current weakness,” he explained. Bearing this in mind, the five-star analyst maintained an Outperform rating and $7 price target, implying a potential twelve-month gain of 220%. (To watch Gershell’s track record, click here)Like Gershell, Aegis Capital’s Nathan Weinstein sides with the bulls. After an FDA AdCom voted unanimously to expand Amarin’s Vascepa label to include cardiovascular risk, the analyst believes that ACST stands to benefit. “In many ways we think it’s still early days in this brave new iteration of the prescription omega-3 category, where enhanced attention is being paid to composition, potential cardiovascular risk reduction benefits, and potentially other patient benefits…To the extent there end up being multiple positive outcomes trials in the space across both EPA only and mixed EPA/DHA compositions, we think that could lend credence to the view that cardiovascular risk reduction is a an effect of omega-3 medications not limited to a pure EPA composition,” he commented. To this end, Weinstein left his Buy rating and $3 price target as is.Looking at the consensus breakdown, 100% of the analysts covering ACST see it as a Buy, making the consensus rating a unanimous Strong Buy. Additionally, the $6.02 average price target puts the upside potential at 175%. (See Acasti stock analysis on TipRanks)VBI Vaccines Inc. (VBIV) VBI Vaccines is best known for developing vaccines for immuno-oncology and infectious diseases. Its hepatitis B vaccine, Sci-B-Vac, has already been approved in Israel and ten other countries, with it currently in a Phase 3 program in the U.S., Canada and Europe. Ahead of the data readout for Sci-B-Vac in the next few weeks, Canaccord's John Newman likes what he’s seeing.The analyst tells clients that he expects the top-line Phase 3 CONSTANT trial data to demonstrate the efficacy of the vaccine, and should include immune repression measures such as geometric mean concentration (GMC) of antibodies across the three independent manufactured groups of Sci-B-Vac. “We continue to believe Sci-B-Vac will be viewed positively by regulators and achieve approval in the US and EU after positive readout in CONSTANT in January 2020. We look forward to an update of two-dose noninferiority data with inclusion of patients from the CONSTANT dataset,” he wrote in a note to clients.On top of this, Newman cites its VBI-1901 candidate for glioblastoma multiforme (GBM) and VBI-1501A for cytomegalovirus (CMV) infection as key points of strength for the company, expecting continued positive data from each.He further added, “Brii Bio and VBI plan to initiate enrollment of a phase 1b/2a proof-of-concept study in subjects with chronic HBV infection in 4Q19E which could allow for initial first-inhuman proof of concept data readout in 2H20E.”Based on all the above factors, the five-star analyst reiterated his bullish call. While Newman did reduce the price target from $5 to $4, this still conveys his confidence in VBIV’s ability to climb 270% higher in the next twelve months. (To watch Newman’s track record, click here)What does the rest of the Street think? Given that 3 Buys and no Holds or Sells have been assigned in the last three months, the stock earns a Strong Buy consensus rating. Not to mention the $3.67 average price target brings the upside potential to 170%. (See VBI Vaccines stock analysis on TipRanks)Veru Inc. (VERU) Veru uses a novel approach to develop and commercialize medicines for prostate cancer. According to one analyst, 2020 could be a big year for Veru, starting with the announcement of new top-line Phase 2 data for Zuclomiphene citrate for hot flashes caused by prostate cancer hormone therapy.The readout, which is scheduled for this month, is an interim topline look at the frequency of hot flashes as well as the safety of the 10mg and 50mg doses. Brandon Folkes of Cantor Fitzgerald notes that a clinically meaningful reduction in hot flashes for Zuclomiphene Citrate is between 11% and 26%, which is how he thinks the treatment will be evaluated by the FDA. In addition, the company's recent FY4Q19 earnings release indicates that there haven’t been cases of side effects like gynecomastia, breast pain or venothromboembolic events (blood clots in legs or lungs, or stroke) that are typically associated with off label use of steroidal estrogens and progestins for hot flashes.“Thus given the lack of these common side effects being seen in the Phase 2 trial, we expect VERU to move forward to test the 100mg dose, which will require 30 patients. We believe that decision should be viewed as a positive. Given that zuclomiphene is an estrogen, we would expect to see dose dependent efficacy in Zuclomiphene citrate, and the lack of safety concerns which enable VERU to move to test the higher 100mg dose is likely to result in a more compelling product offering, should the product come to market,” Folkes stated.To top it off, Phase 1b data from VERU-111 for castration resistant metastatic prostate cancer is expected in early 2020, with Veru already indicating that there’s evidence of substantial antitumor activity.All of this prompted Folkes to maintain a Buy rating along with a $6 price target. At this target, a 67% twelve-month rise could be in the cards. (To watch Folkes’ track record, click here)Turning now to other analysts, they appear to be on the same page. With 3 Buys compared to no Holds or Sells, the message is clear: Veru is a Strong Buy. The average price target of $5.83 suggests 62% upside potential, just below Folkes’ forecast. (See Veru stock analysis on TipRanks)

  • Benzinga

    Acasti Delays Data Readout For Drug To Treat Elevated Triglycerides

    Micro-cap biopharma Acasti Pharma Inc (NASDAQ: ACST) issued an update regarding a delay in a clinical readout. Acasti said late Monday it's postponing the release of top-line results for the TRILOGY 1 pivotal Phase 3 study of CaPre to January, citing an unexpected delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation. CaPre, a highly purified omega-3 phospholipid concentrate derived from krill oil, is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis.

  • Benzinga

    Benzinga Pro's Top 5 Stocks To Watch For Tues., Dec. 24, 2019: TSLA, WCC, ACST, YMAB, ITCI

    Benzinga Pro's Stocks To Watch For Tuesday Tesla (TSLA) - Shares moved over the controversial "funding secured" $420 level which Elon Musk famously tweeted about in the summer of 2018. The intraday ...

  • Benzinga

    The Daily Biotech Pulse: NewLink Genetics Licenses Ovarian Cancer Dug, Correvio Awaits FDA Verdict

    Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Dec. 23) 10X Genomics Inc (NASDAQ: TXG )(reacted to a ruling ...

  • GlobeNewswire

    Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre

    Acasti regrets the delay due to factors outside its control, and now anticipates to report topline results in January 2020. As requested by the Investment Industry Regulatory Organization of Canada (IIROC), due to market volatility, the Company indicates that it has no material update to provide at this time beyond the above timing update and independent and external validation exercise that is underway.

  • Hedge Funds Have Never Been This Bullish On Acasti Pharma Inc. (ACST)
    Insider Monkey

    Hedge Funds Have Never Been This Bullish On Acasti Pharma Inc. (ACST)

    The market has been volatile in the last few months as the Federal Reserve finalized its rate cuts and uncertainty looms over trade negotiations with China. Small cap stocks have been hit hard as a result, as the Russell 2000 ETF (IWM) has underperformed the larger S&P 500 ETF (SPY) by more than 10 percentage […]

  • Amarin Stock is at Sky-High Levels Already Assumes All the Good News
    InvestorPlace

    Amarin Stock is at Sky-High Levels Already Assumes All the Good News

    On Friday, Dec. 13, 2019, the FDA approved an expanded cardiovascular claim for Vascepa, a drug produced by Amarin (NASDAQ:AMRN). Prior to this patients with very high triglyceride levels were only ones approved to use Vascepa.Source: Pavel Kapysh / Shutterstock.com Now those with lower levels and other signs of heart or diabetes issues can use it. This vastly expands the population to whom Amarin can sell Vascepa. Those with greater than 150 milligrams per deciliter can now use the drug. Amarin estimates that "millions" (with no specific number associated with that noun) can benefit from its drug.A previous advisory committee had unanimously recommended that the drug be approved. There was a high likelihood that the FDA would approve Vascepa for expanded cardiovascular treatment.InvestorPlace - Stock Market News, Stock Advice & Trading Tips Amarin Stock Includes a Lot of Good NewsAnalysts have already argued that Amarin's Vascepa, its only drug, will bring in greater than $1 billion annually in sales, with peak sales above that. One analyst, Nathan Weinstein, at Aegis believes the drug could hit $2 billion in sales by 2025. His peak price target was $23 per share.The problem is Amarin stock is already very close to that target price, at $21.36 per share. In other words, a lot of the good news is already implied in the valuation of AMRN stock. Another analyst, at Stifel, has put a hold recommendation on Amarin stock. His price target is $28 per share. * 7 'Strong Buy' Stocks to Put on Your Wish List Amarin announced that it expects its 2020 U.S. sales to be between $650 million to $700 million from sales of Vascepa. Seeking Alpha's database of eight analysts have an average estimate of $692 million in revenue for 2020.That puts Amarin stock on a forward price-to-sales ratio of 11.9 times. That is an extremely high valuation metric. It would normally be the number for a conservative stock's price-to-earnings ratio.It implies that a bidder for all of AMRN stock would have to wait almost 12 years before their investment would equal the sales achieved, not earnings. Not too many companies would be willing to do that.Clearly the market expects that sales will climb significantly over the next 12 years. There are tw0 problems with that theory: competition and patent issues. Problems With the ValuationThe FDA is also looking at similar drug studies from: AstraZeneca (NYSE:AZN), whose drug is called Epanova; Acasti Pharma (NASDAQ:ACST), with CaPre; and, Matinas BioPharma (NYSEAMERICAN:MTNB), with its MAT900i drug.A recent analyst article in Seeking Alpha assessed these three competitors and the state of play of their drug applications. The analysts considered these companies competitive threats to Amarin and its Vascepa drug.In addition, Amarin is facing patent lawsuits from several companies. These include Dr. Reddy's Laboratories (NYSE:RDY), an Indian pharmaceutical company, and Hikma Pharmaceuticals (OTCMKTS:HKMPY), a generic pharma company. However, bullish analysts point out that Teva (NYSE:TEVA) has already settled with Amarin.Most of these suits, including one that begins in January, concern the validity of the core of Amarin's patent family. It is called "Methods for treating hypertriglyceridemia." Another patent for "Stable pharmaceutical composition and methods of using same" family is also in litigation. * 5 Large-Cap Dividend Stocks to Buy If Amarin loses these cases, it could lose all patent protection. Other drug companies could use their ideas.As it stands the patents give Amarin protection until 2029, or 10 years. This is Amarin's only product, so it has to make hay during that period with Vascepa. What Should Investors Do?AMRN is a high-risk, high-return stock. As always, I recommend only buying on dips and during bad news with these kinds of stocks. They are essentially a mild form of gambling, although some risks can be minimalized with probability analysis.Given that a prior panel recommended for Vascepa, the AMRN stock price already discounted last week's FDA good news. Analysts seem to agree. Their target values are not significantly higher than the present price.Investors should look for an opportune time to jump in. Analysts will likely scrutinize the patent protection litigation closely in January. Look for an opportunity then to consider investing in Amarin stock.As of this writing, Mark Hake, CFA does not hold a position in any of the aforementioned securities. Mark Hake runs the Total Yield Value Guide which you can review here. The Guide focuses on high total yield value stocks. Subscribers a two-week free trial. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * The 8 Biggest Investing Surprises of 2019 * 7 Impressive Stocks to Buy Over $250 * 4 Small-Cap Energy Stocks Ready to Explode The post Amarin Stock is at Sky-High Levels Already Assumes All the Good News appeared first on InvestorPlace.

  • GlobeNewswire

    Acasti Pharma Reports Last Patient Visit in TRILOGY 1 Phase 3 Trial of CaPre for the Treatment of Severe Hypertriglyceridemia

    LAVAL, Québec, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), announced that the last patient completed their final visit in the Company's TRILOGY 1 pivotal Phase 3 trial of CaPre last week. Topline results for TRILOGY 1 are expected to be reported as planned in December 2019.

  • Encode Ideas, L.P. Announces the Initiation of Research Coverage on Acasti Pharma, Inc.
    Newsfile

    Encode Ideas, L.P. Announces the Initiation of Research Coverage on Acasti Pharma, Inc.

    Dover, Delaware--(Newsfile Corp. - November 25, 2019) - Encode Ideas, L.P. Initiates Research on Acasti Pharma, Inc. (NASDAQ: ACST). The full research publication is available here and available on our website at www.encodelp.com. Encode Ideas is initiating coverage on Acasti Pharma, Inc. as a high-risk investment idea. Acasti is developing a krill-based omega-3 fatty acid product, CaPre, for the treatment of severe hypertriglyceridemia. Acasti is currently conducting two virtually identical Ph3 studies - ...

  • Amarin's Shares Down on Underperform Rating by Oppenheimer
    Zacks

    Amarin's Shares Down on Underperform Rating by Oppenheimer

    Amarin's (AMRN) shares decline as the independent advisory firm, Oppenheimer, initiates coverage with an Underperform rating on the back of concerns related to its marketed drug, Vascepa.

  • GlobeNewswire

    Acasti Pharma Releases Preliminary New Animal Data, and Gains Insights Into CaPre’s Novel Mechanism of Action in Diabetes

    Despite the lower concentration of EPA in CaPre’s composition, the actual levels of 18RS-HEPE (a metabolite of EPA) reached in the blood were higher for CaPre than levels produced by icosapent ethyl. 18RS-HEPE and Resolvin E1 are both involved in the resolution of inflammation that is triggered in many chronic diseases including obesity and diabetes.

  • GlobeNewswire

    Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2020

    LAVAL, Québec, Nov. 13, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today provided a business update and announced its operating and financial results for the second quarter of fiscal 2020 ended September 30, 2019. “Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to become a best-in-class omega-3, due to both the Trifecta Effect and greater bioavailability, especially in patients that follow the standard physician-recommended, restricted low-fat diet.

  • GlobeNewswire

    Acasti Pharma Announces Publication of CaPre Pharmacokinetics Study in a Leading Peer-Reviewed Journal

    LAVAL, Québec, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, “Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers” in a leading peer-reviewed journal, Clinical Therapeutics. The study publication is available online and can be accessed at: https://www.clinicaltherapeutics.com/article/S0149-2918(19)30499-0/fulltext .

  • GlobeNewswire

    Acasti Pharma Schedules Second Quarter Fiscal 2020 Conference Call

    Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Wednesday, November 13, 2019 to discuss the Company’s financial results for the second quarter ended September 30, 2019, as well as the Company’s corporate progress and other developments. The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company’s News and Investors section of the website: https://www.acastipharma.com/investors/.

  • GlobeNewswire

    Acasti Pharma Partners with Aker BioMarine to Supply Krill Oil for CaPre®

    LAVAL, Québec, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has partnered with Aker BioMarine to deliver krill oil to Acasti, under a two-year, fixed price supply agreement. Raw Krill Oil (RKO) is the starting material used by Acasti to make CaPre, which is then further processed via a series of complex and proprietary extraction and purification manufacturing steps to produce the drug substance for CaPre.