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invest83, Indeed it was Denner's name that caught the eye of Zach's but also don't forget it is a turnaround situation or as I consider it to be similar to a start up with all the same struggles and headaches that go along with a new company. Fortunately, there's cash in the till along with a prudent BoD and the wind at our backs.
sleven, based upon the docs I found it appears to be a schedule of docs due well in 2025. More of the same BS. It's never ending!
CBB, If AD brings his ownership to 20% that would mean he'd own over 80mill shs of stock I guess it would depend on a couple of reasons why....if there's a VERY bright future for V and if the share price stays around this area he may be able to pull it off?
Form SC 13D/A AMARIN CORP PLC\UK Filed by: Sarissa Capital Management LP
10K WIZARD 7:30 AM ET 12/5/2023
http://archive.fast-edgar.com/20231205/AD2ZL22CZZ22M2JU22JI2M42AAS2ZC22ZW52
Filed on: December 5, 2023
Denisk, sarissa owns over 29mill according to last filing. He's no fool. We'll see tomorrow if those blocks at close were his purchases.
capt, good news. Congrats to you. If you don't fight against the establishment you'll be just another lemmon following the pack. Gotta fight for your rights or get trampled on.👍️
I'm speaking from personal experience. 😉
tatsu, we'll know tomorrow how many more shs Sarissa owns when they file their 13D.
Keep the faith. We're in good hands.
FYI..
Sarissa Capital Believes Amarin Stock Is Meaningfully Undervalued and Has Increased Its Ownership
BUSINESS WIRE 4:23 PM ET 12/4/2023
Symbol Last Price Change
AMRN 0.704down -0.046 (-6.1333%)
QUOTES AS OF 04:00:00 PM ET 12/04/2023
Sarissa sees turnaround in progress but it will take time
Sarissa has not sold any Amarin(AMRN) shares
GREENWICH, Conn.--(BUSINESS WIRE)-- Sarissa Capital Management LP (“Sarissa”) today issued the following statement regarding Amarin Corporation plc(AMRN) :
Sarissa believes Amarin’s stock is significantly undervalued. We continue to believe in both the tremendous value of Vascepa/Vazkepa to cardiovascular patients worldwide and the market opportunity. We are very upset that the stock has remained low. We expect that over time that value will be reflected in the stock price. We hope that recent progress detailed below will cause the stock to begin to reflect the value we think it has.
We remain long-term shareholders and have been purchasing shares at these depressed prices, as will be detailed in tomorrow’s 13D filing. We have never sold any shares of Amarin(AMRN) and have only increased our position since we made the investment.
Since reconstituting the board nine months ago, Amarin(AMRN) has made significant progress to strengthen its business operations and corporate governance and to remake the company for shareholders:
Reorganizing the leadership team under new CEO Patrick Holt with his international leadership and turnaround operating experience
Streamlining the U.S. business to maximize cash flows
Reworking Europe’s commercial infrastructure and pricing and reimbursement activities to be more effective and cost-efficient in key markets
Achieving national reimbursement approvals and launches of Vazkepa in Europe, including in Spain, Netherlands, and Scotland, as well as in China through EddingPharm
Securing multiple international partnership deals, including in Australia/New Zealand, South Korea and Southeast Asia, to grow Vazkepa globally
In Sarissa’s experience, turning around companies takes time. We are pleased with the progress that Amarin(AMRN) has made to date and expect the value to be reflected in the stock price over time. We share all shareholders’ frustration in the low stock price.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of U.S. securities laws, including, but not limited to, expectations regarding Amarin’s stock value and financial performance, metrics, and initiatives, including beliefs about the overall world-wide market potential of VASCEPA/VAZKEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A list and description of these risks, uncertainties and other risks associated with an investment in Amarin(AMRN) can be found in Amarin's(AMRN) filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the year ended December 31, 2022. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Except to the extent required by applicable law, Sarissa will not undertake and specifically declines any obligation to disclose the results of any revisions that may be made to any projected results or forward-looking statements herein to reflect events or circumstances after the date of such projected results or statements or to reflect the occurrence of anticipated or unanticipated events.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231204232430/en/
Source: Sarissa Capital Management LP
ANy one notice the block trade at the bell? 234,591 shs above the offering price. It was probably a vwap trade.
north, SGEN is being bought by PFE but you know that cause you're on top of your DD. I believe they got the all clear to proceed with BO.
seve, if you read the jasbg post with analyst estimates we'll probably have to wait till 2025 for revenue growth but generally speaking, I think we knew that cause it will take another yr for amarin to ramp up sales in the EU and ROW barring no new developments with the application of EPA for AD. Plus the global economy may be on the upswing by then. As I've said in the past GIA in the EU is like a startup company with a business plan that has raised a few hundred million to get them on the road to sustainability. Then we may be surprised by a BP offer...Hope springs eternal!
Sleven, this was listed late last night. See below.
CBB, after reading Rose and Ram's reminder that the diabetes/diet drugs being rebranded don't have generics to contend with but in China I think that idea would be possible no generics there.....yet.
Happy Thanksgiving to all!!!!
Rose, how can BP do the 2 brand marketing for the same drug and be successful ? Why can't amarin do the same? Read the article I posted.
Sleven, my point is maybe approval for reimbursement is imminent and we dont know it.
Sleven, let's hope they're not jumping the gun in Portugal like KM did in Germany. Millions wasted
Sleven, I receive notices which r pushed to me by linkedin. I've noticed they're cranking up the job hunt in many EU locations.
CBB, interesting approach. Let me think about how to push this concept to Sarrisa.
Sleven, the PR I copied mentioned Portugal but when I opened the article it didn't include Portugal. I don't understand the info AI spits out. It's not accurate.
Sleven, the below info is the only mention of Portugal when I search Bing AI. Nothing about approval to sell yet. Maybe the company knows something we shareholders don't...wouldn't be the first time.
https://markets.businessinsider.com/news/stocks/amarin-receives-european-commission-ec-approval-for-vazkepa-to-reduce-cardiovascular-risk-1030257919
Sleven, they've had several ads listed for hire on LinkedIn throughout the EU where they've been approved to sell V and one listed for Bridgewater.
This article should be forwarded to the CEO of amarin or whoever would make a major decision to change the name of Vascepa to something more relevant relating to CVD prevention in the USA this move may get rid of the generic issue of infringement. Retain the Vascepa brand for HTG and rebrand the FDA approved Vascepa for CVD to a more relevant name!!!
Does anyone have a contact name within the company? Capt maybe????
https://endpts.com/why-did-lilly-give-tirzepatide-a-new-name-for-obesity-hint-its-the-marketing/
Feedback please....
DAR53, LOL the vol yesterday was 143,517,299. The price of stock end of Oct. $.20. 🤣
I'd have to read the filings to make any sense of the price action, squeeze maybe???
north, something is weird about the trading volume of CDIO. it was a SPAC that CDIO merged into. SPAC priced at $10 but I think the shares out are locked up or restricted to insiders. Check the charts they are screwy-looking, and need much DD before considering buying shares. But if it's real then the stock appears to be cheap. Too many what if's......
additional PR from the AHA
Effectiveness of Icosapent Ethyl on Cardiovascular Events in Patients with Metabolic Syndrome: simultaneous publication of the REDUCE-IT MetSyn study presented at #AHA23#OpenUpYourScience with #EHJOpen!@ESC_Journals @SaDeRosa78 @ProfMagnusBack https://t.co/dEA1YRvkUJ
— EHJOpen Editor-in-Chief (@ehjopen) November 12, 2023
#AHA23 #Cardiology #CardioTwitter @ehjopen @ESC_Journals https://t.co/IQLM4ZbAjY
— Dr. Deepak L. Bhatt (@DLBHATTMD) November 13, 2023
capt, sorry please ignore the last post I didn't see the charts stating the numbers were for capsules. I thought it was for the total amt of bottles sold. Bummer.
Capt, do we know the pricing for V in the UK? I wonder how this will affect revs in the 4th qtr?
north, been following CRISPR for a while, you have to have a strong stomach for the price action but believe it has long term potential.
jasbg, wtf why didn't amarin PR this tweet?
We're thrilled to congratulate our partners, Eddingpharm, who have received confirmation that China’s NMPA has accepted its marketing application for a potential Cardiovascular Risk Reduction (CVRR) indication for VASCEPA (icosapent ethyl).
— Amarin (@Amarincorp) November 16, 2023
north, we need volume to get momentum on the upside.
north40000,👏👏👏
Actually, I'm intrigued by the kiwi post re using AI to detect the possibility of an early heart inflammation condition. Too bad the company mentioned, Caristo Diagnostic, is a private company.
ramfan, magic number is .8255, 50 day MA we need to close over that number.
If anyone cares a block of 131,891 shs traded at the open @.80👍️
ORBAPU, thanks for post. The 50day MA is @.8255 🤞
Capt, very impressive letter. Follow the money. I wonder if a kickback from Hikma in some form or another is going to the insurance company???
Good luck 🤞 with your appeal.
Robin, I'm sure Amarin will do a PR tomorrow but will it move the needle, I doubt it. It's just a lousy time geopolitically speaking to try and launch a new drug. I've always had a bad feeling about the GIA approach since JT first announced their efforts a few yrs ago.
news from AHA
New REDUCE-IT® Analyses Show VASCEPA® (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline
GLOBENEWSWIRE 9:00 AM ET 11/12/2023
Symbol Last Price Change
AMRN 0.7244down -0.0106 (-1.4422%)
QUOTES AS OF 04:00:00 PM ET 11/10/2023
-- Analysis Also Found IPE Was Associated with a 41% Reduction in Total Events Compared with Placebo --
-- Subgroup Almost Exclusively Comprised of Patients with Established Cardiovascular Disease --
-- Findings Continue to Reinforce the Scientific Data and Clinical Use of VASCEPA®/VAZKEPA® to Reduce Cardiovascular Risk --
-- Results Presented Today at the American Heart Association (AHA) Scientific Sessions 2023 and Simultaneously Published in the European Heart Journal Open --
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc(AMRN) today announced results from new REDUCE-IT analyses showing that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of VASCEPA/VAZKEPA (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. This subgroup was almost exclusively comprised of patients with established cardiovascular disease. The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.
More than 1 out of every 3 adult Americans have Metabolic Syndrome, a cluster of 3 or more of 5 risk factors: 1) waist circumference ≥40 inches [102 cm] in men and ≥35 inches [88 cm] in women, 2) blood pressure ≥130/85 mmHg, 3) glucose ≥100 mg/dL, 4) triglycerides ≥150 mg/dL, and 5) HDL-C <40 mg/dL in men and <50 mg/dL in women.
Among patients with Metabolic Syndrome but without diabetes at baseline (n=2866), those who were allocated to icosapent ethyl (IPE) treatment with a median follow-up time of 4.9 years experienced a 29% relative risk reduction for the primary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina resulting in hospitalization (P <0.0001) (Absolute Risk Reduction [ARR]=5.9%; number needed to treat [NNT]=17) and a 41% reduction in total (first plus subsequent) events (P <0.0001) compared with placebo. The risk for the key secondary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was reduced by 20% (P=0.05) and there was a 27% reduction in fatal/nonfatal myocardial infarction (P=0.03), 47% reduction in urgent/emergent revascularization (P <0.0001) and 58% reduction in hospitalization for unstable angina (P <0.0001). Non-statistically significant reductions were observed in cardiac arrest (44%) and sudden cardiac death (34%).
The large relative and absolute risk reductions observed supports IPE as an important therapeutic option for patients with metabolic syndrome at high cardiovascular risk, despite lacking robust effects on any metabolic syndrome component.
“These subgroup findings provide us with valuable insight into the role icosapent ethyl may play in helping reduce the risk of cardiovascular events in patients with Metabolic Syndrome, but without concomitant diabetes, including those secondary prevention patients with established cardiovascular disease, a patient group particularly at high-risk of having another cardiovascular event,” said Michael Miller, M.D., cardiologist and Chief of Medicine, Corporal Michael J Crescenz Veterans Affairs Medical Center and Professor of Medicine, Hospital of the University of Pennsylvania in Philadelphia. “This is an area of growing concern for the medical community and for patients globally, given the steady rise in the number of patients with Metabolic Syndrome across the U.S. and around the world.”
Commenting on the findings, Amarin’s Chief Medical Officer Nabil Abadir said, “These data continue to reinforce the clinical value of IPE and expand the growing list of benefits attributable to the molecule, including secondary prevention patients such as those with prior myocardial infarction, percutaneous coronary intervention or coronary bypass grafting, chronic kidney disease, heart failure, and history of cigarette smoking.”
Limitations of these analyses, some of which are exploratory in nature, include the relatively small number of events in certain subgroups or for certain endpoints, such as cardiac arrest and sudden cardiac death. In addition, variation in subjective measures (e.g., waist circumference) may have affected classification of metabolic syndrome.
About Metabolic Syndrome
Metabolic Syndrome is a cluster of conditions that increase the risk of heart disease, stroke and Type 2 diabetes mellitus (T2DM). Metabolic Syndrome is defined as the presence of any three of the following five risk factors: increased blood pressure, high blood sugar, excess body fat around the waist, low HDL cholesterol, or elevated/high triglyceride levels.1 Metabolic Syndrome is increasingly common,1 and more than 1 out of 3 people in the United States have it. Metabolic Syndrome is not only associated with a two-fold increased risk of adverse cardiovascular disease (CVD) outcomes (e.g., myocardial infarction, stroke and CV mortality), even in the absence of T2DM, but in recent years has also been linked to a variety of pathogenic phenotypes including heart failure and renal insufficiency.2,3,4
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year,5 and the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.6 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.7,8,9
About REDUCE-IT ®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.10 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 201811. The total events 12 and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
As an adjunct to maximally tolerated statin 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.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM .
About Amarin(AMRN)
Amarin (AMRN) is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin(AMRN) has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation
HLS earnings release V sales continue to grow.
https://hlstherapeutics.investorroom.com/2023-11-09-HLS-Therapeutics-Announces-Q3-Fiscal-2023-Financial-Results-and-Renewal-of-Normal-Course-Issuer-Bid
bobwayne, so @10:19 there was 800K trade in the middle of the market .6954 which is a black print. Then @10:51 822,609 traded @.685 which appears to be a sell=red print.
bobwayne, my time and sales for amrn show it was a sell @.685 but for every seller, there's a buyer!