Amarin Corp PLC【AMRN】株式ニュース

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Form 8-K - Current report

Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal

-- Portuguese Ministry of Health approves VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the...

Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024

DUBLIN and BRIDGEWATER, N.J., July 17, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today...

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

-- VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular...

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

-- Board Appoints Aaron Berg as President & CEO -- -- Patrick Holt to Step Down as President & CEO to...

Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

-- Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce...

Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference

DUBLIN, Ireland and BRIDGEWATER, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN...

Amarin Reports First Quarter 2024 Business Update and Financial Results

-- New VAZKEPA® Patent Issued by European Patent Office Extends Intellectual Property Protection in Europe...

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

DUBLIN, Ireland and BRIDGEWATER, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

-- Findings Presented on VASCEPA/VAZKEPA Utility in REDUCE-IT Patient Subgroups by Baseline High/Low Lp(a...

Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe

DUBLIN, Ireland and BRIDGEWATER, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

ramfan60 32分前

unfortunately Kiwi, your health and family history dictates that you should be taking everything that you are taking. You are metabolically challenged. A healthy person with an LDL over 180 shouldn't be on anything. It's just one biomarker amongst many. Tell me..... do all these well known and respected Cardiologists prescribe Vascepa for their patients? I seriously doubt it..... they rely on old studies and group think. All the males on my fathers side also died of heart related illnesses as well. In their case, they were all heavy smokers and drinkers. If you are going to subject your body to that level of smoking and drinking, you can imagine that their diet was just as bad.

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DMC8 3時間前

https://www.fiercebiotech.com/biotech/novartis-took-data-heart-slimming-clinical-pipeline-40-says-ceo

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FlyFishingStocks 7時間前

Well hey thur Mr. head-in-the-sand,

"Frantic attempt?" Please, why don't you pontificate as to what catalyst over the next 180 days might elevate the stock price by MORE THAN 100%!!??

Odds are NOT in your favor. Rather, your investment has a high likelihood of melting down as Amarin's cash burn rate accelerates moving forward, towards the inevitable bankruptcy threshold. That's when the company gets taken out privately.

Yup, you have avoided every single flashing red light and warning sign to "Go back! Do not proceed beyond this point!" The consequences must be tightening or you wouldn't bash every contrarian post you disagree with.

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rosemountbomber 9時間前

Yes, you are correct and I believe what you are referencing is the delivery system, i.e. in our case the patent capsule design which makes a big difference.

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Whalatane 9時間前

Well if your LDL cholesterol is below 70 mg/dl then you are correct ...theres not much net positive .
But if your LDL is over 180 mg/dl the CV risk reduction from lowering your LDL to below 100 mg/dl has been extensively documented ,verified by almost 20 clinical trials and advocated by Dr Bhatt and all well known and respected Cardiologists .
But you do U
Meanwhile I'll take my Repatha and Crestor ...and drive my LDL cholesterol below 50 mg /dl .....and for the record ...be the only male on my father's side of the family to live past 62 . ( I'm now mid 70's )
All others died of fatal heart attacks
Repatha , Crestor and a Vascepa chaser
Kiwi

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ORBAPU 10時間前

No one in academia really wants to face up to the growing realization that there's not much net positive to lowering LDL-C.

https://www.tandfonline.com/doi/full/10.1080/17512433.2018.1519391#d1e2266

http://knowingyourjargon.blogspot.com/2017/12/statins-and-number-needed-to-treat-nnt.html

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CaptBeer 10時間前

My problem is with how BE is determined for generics. Bioequivalence is not the same as Therapeutic Equivalence. I still don't believe that generic VASCEPA is therapeuticly equal to VASCEPA. Thus, generics may equally reduce TG levels as VASCEPA, but for many reasons which I explained here before, I'm not convinced that they deliver the same levels of EPA to the endothelial cells. Mochida in Japan tested this theory and found that generics don't stand up to brand EPADEL-300.

I'll continue to believe it's not the TG's. It's the EPA stupid, and that goes the same for generics.

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rosemountbomber 12時間前

Nuke you are right about cost being the issue. I think Germany has basically alluded to that in a roundabout way by referring benefit/cost ratio.

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rosemountbomber 12時間前

As an investor here, I fully support your efforts in that regard since it would help our situation here. Unfortunately as a chemist, I wouldn't agree. A drug being shown to be the same or equivalent to another has nothing to do with what indication it is used for.

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Nukemtiltheyglow 12時間前

Yes, thanks RMB & North. I agree Meta-Analysis can be rigged. My underlying question really should have been is; Why Germany chose to reimburse ezetimibe over Vascepa? If it were my guess, I would have said "cost." Just as much "bang for the buck" going with ezetimibe? I'm thinking this points to Amarin coming out with an Approved Generic version of Vascepa (strategy wise?). An AG wouldn't need to undergo any Phase studies, correct? Whereas the Lymphatic version (new formulation) would require FDA testing and approval?
As for which statin to use? I didn't like Generic Lipitor, body aches and headaches. I liked Livalo (1 mg/day) for that reason (no side effects), but the cost was an issue. Since I've gone with a Low dose (10 mg) of Generic Pravastatin (thanks to captain), I've not felt the same side effects.

Too many factors point to Amarin needing to come out with a Generic version. The Chinese market may demand it. As for the US market, once the Hikma infringement issue is settled, a generic would work and effectively return the US market back to Amarin's favor.

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CaptBeer 12時間前

I have written several times to the FDA and to the Senate HELP Committee about the FDA's flawed bioequivalence (AB Rating) System. In the case of skinny labels, it needs to be changed to reflect each indication separately instead of the current system that only references the original drug regardless of the indication.

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CaptBeer 13時間前

In spite of the recent hoopla about LDL-C (The lower, the longer, the better), researchers are finding that significant residual risk for ASCVD remains. The pathways are complex, but in general Triglyceride Rich Lipoproteins, sometimes called Remanent Particles, are known to be better markers of ASCVD risk than LDL-C. Can you think of a therapy that targets these TRLp’s?

https://academic.oup.com/ehjopen/article/4/4/oeae057/7723268?login=false

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DMC8 14時間前

Reminder:
Strongly encouraged you to lodge a complaint with FINRA if you have not done so. 🙏
This ticker does not deserve to be manipulated. Thanks!

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175402794

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ramfan60 14時間前

Nice.....I like him. He gets it.

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rosemountbomber 22時間前

Thanks Capt. I guess to some degree it doesn't matter much since V is an approved drug and so forth. Not sure how much micro managing the head of the FDA would get involved in when it comes to the new formulation. I guess they have set rules they follow.

I find it interesting in a philosophical context that the FDA does not seem to get more involved with infringement. I mean they don't condone companies selling unapproved drugs, yet in a sense, for instance in our case, a drug is being sold that is not approved for the intended purposes many patients are taking it.
Oh well, just my frustration showing. Have a great weekend to you and the board.

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Whalatane 22時間前

Nuke ...If U accept the R-IT data , especially the AHA data that Capt just posted ....Vascepa is far more effective than Ezetimbe in reducing CV events ...at least in R-IT profile patients .
Ezetimbe ( Zetia ) is generic , cheap and a small pill ( if taken separately ) and is often added to low dose Statins if the patient needs to lower their LDL further but is complaining of new muscle aches etc on their current dose .
I took it for years ,,,but once I started taking Repatha with Crestor and Vascepa ....I dropped it . Repatha ( a PCSK9i ) and Crestor dramatically lower LDL cholesterol .
IIRC half in R-IT were on high intensity statin , mainly Lipitor and the other half on low intensity Simivastatin
Kiwi

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CaptBeer 22時間前

I've tweeted dr McKary in the past about VASCEPA so, I'm pretty sure he is aware of it.

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rosemountbomber 1日前

Marty Makary to be next head of the FDA. Sounds like he wasn't the biggest fan of GLP-1 drugs. Hope he is aware of V, and is amenable to our new formulation, if it ever comes out.

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ORBAPU 1日前

You seem to be gaslighting yourself. Boilerplate language. RS is and always has been an option. If that was their priority, they had plenty of time to do it. Go back and reread the 8k, take as long as you like. Report back when you find the word "open".

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caddiedad 1日前

What exactly is your frantic attempt of a question? AMRN now has 180 days to get pps over $1.00 for 10 trading days. Plenty of catalyst possibilities upcoming to help the cause. Your post makes a cup of coffee nervous

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Mr Stockboy 1日前

Now I might have a tough decision no thanks to the 8K. AMRN is open to the option of a R/S.

Spin me a tale but the investor basically loses, as after the R/S the pps falls again. Value is totally loss.

If someone can legitimately make a case for R/S to the investor's advantage, please do. I've only witnessed disaster. I mean this; An open invitation to anyone supporting a R/S. AMRN could buy back shares and be instantly compliant irrespective of the cash burn. I'd really like to read intelligent discussion between R/S and share BB.

Thank you friends.

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Denisk 1日前

IMO it's all relative to each individual condition & health problems. They do say however many review's say " According to study group results, a daily dose of atorvastatin 10 mg can decrease LDL cholesterol by 30%-40% while a daily dose of simvastatin 10 mg can decrease LDL cholesterol by 20%-30%., which is one of main attributes of the statins "to reduce cholesterol".
There be reasons why your physician ordered simvastatin versus atorvastatin?

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north40000 1日前

Nuke, rmb: At my request, my PCP put me, via prescriptions, on both ezetimide and Vascepa. That was before I started mg ion per Dr. Dean's books discussed some weeks ago here. Suffice to say he was pleased with my latest blood sample test results. Information I have seen shows that number of prescriptions for ezetimide are far greater than prescriptions for Vascepa, both in Europe and in United States. I had been prescribed simvastatin for many years prior to either of the other 2 drugs.

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Denisk 1日前

Come on, it's after 3pm on the West coast & past 6 on east coast. You don't expect that anyone is really watching or is aware of the release. We'll see what happens Monday at the earliest. Right now the news has not even been published on brokers trading sites i.e Etrade shows nothing.

Not everyone is constantly watching what AMRN does , like you do, every second it seems...

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ProLiberty 1日前

Interesting that there was a lot of after market volume yesterday as well as pre market volume this morning. But now, post the 180 day extension notice, next to no volume in the first 2 hours of the after market.

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lizzy241 1日前

It's official.

BRIEF-Amarin Corp - Nasdaq Granted 180 Days To Regain Nasdaq Compliance
REUTERS 4:55 PM ET 11/22/2024
Symbol Last Price Change
AMRN 0.5486up +0.0237 (+4.5151%)
QUOTES AS OF 04:00:00 PM ET 11/22/2024
Nov 22 (Reuters) - Amarin Corporation PLC(AMRN):

* AMARIN CORP(AMRN) - NASDAQ GRANTED 180 DAYS TO REGAIN NASDAQ COMPLIANCE Source text: [https://tinyurl.com/bdhep7ek] Further company coverage:

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ProLiberty 1日前

The just filed 8-K: https://www.sec.gov/Archives/edgar/data/897448/000095017024130263/amrn-20241122.htm

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ProLiberty 1日前

If they were intent to reverse split they didn't need the extension. Good sign. I continue to think that between Italy, possibly China, possible Sarissa add, and initiation of buyback it can get back above $1 inside 6 months. The extra time also gets us past year end tax loss selling pressure.

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Bullrunner2 1日前

Someone posted it..

180 day extension granted.

Amrn 8k filing email. I get a 404 error on it.

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rosemountbomber 1日前

Nuke, not easy to give an ABC answer. First, one can say that medium intensity statins plus ezetimibe did show benefits over simply high intensity statins. But, this was a meta-analysis, and those are notorious since the authors decide what studies to pick and choose. Now the benefits over HIS by this combo was not as great as what Vascepa showed in R-I, BUT I can't find where there is a description of the statin used in R-I - whether it was Mid intensity or High intensity or low, but we do know that people were generally considered to having their cholesterol under control.

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seve333 1日前

They have not cared to inform us about anything since they took over.

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Whalatane 1日前

Thx Capt. https://www.ahajournals.org/doi/10.1161/circ.150.suppl_1.4140394

Clear separation in event lines by yr 2 . If you want to get reimbursement in Germany then run a small short trial with German patients to see if you can get the event lines separating as fast as they have by yr 2 in this abstract .

You only need about 1200 patients to try and reproduce these results
In patients without CAD, IPE demonstrated a 34% relative risk reduction in first (HR 0.66; 95% CI 0.51, 0.85; P=0.0012; NNT 13) and 47% reduction in total primary endpoint events (RR 0.53; 95% CI 0.40, 0.70;

NNT of 13 ?...47% reduction in total primary endpoint events ?

Good reminder to take my daily V :---)

Kiwi

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Nukemtiltheyglow 1日前

Thanks Captain; Would someone please weigh-in on this ezetimibe study and compare it to icosapent ethyl? I know very little about interpreting Statistical Information, especially medical information. Is ezetimibe better or not? European Heart Journal article dated 28 October 2024.
https://academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.3300/7839090

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lizzy241 1日前

RMB, IDK about that particular settlement I didn't find anything in the public domain which includes a PBM. According to my research, I found HIKMA has several PBM's they deal with due to the insurance companies that distribute their GV. My response was more of a generic example of "what if".

https://www.fiercepharma.com/pharma/hikma-pharmaceuticals-accuses-adversary-amarin-keeping-lock-api-suppliers-preventing-generic

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lizzy241 1日前

proliberty, Denner agreed with Biogen. He stepped down and appointed his girlfriend to his seat. See below.
Denner's personal life is a bit strained at the moment. LOL

https://www.biopharmadive.com/news/biogen-board-denner-langer-directors/652838/

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RT Vegas 1日前

Good luck MMS!
I have 150K shares @ average $1.88
Picked up a pile of Jan 1.00 calls (after not purchasing options for well over a year).
Hoping, but not counting on, a Festivus miracle for all longs.
Cheers!
RTV

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ProLiberty 1日前

Per the WhaleWisdom 13F summary below, Sarissa dumped Biogen (a long held mistake for them and formerly their largest position). Innoviva is now the largest position at 35%. Amarin about 3.9%. https://whalewisdom.com/filer/sarissa-capital-management-lp

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mrmainstreet 1日前

Bought a small number of shares and averaged down to $2.55

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rosemountbomber 1日前

Hate being a PIA, but is seems that understand what North is talking about wrt some sort of settlement (Hikma/PBM/Amarin). Since I don't quite know about this (North has even alluded to him possibly making this up) and even JRoon was inquiring as to what North was referring to, could you elaborate for us in simple terms we can understand? TIA

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Monk4444 1日前

Capt
Thanks
Happy Thanksgiving have a cold one for me

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lizzy241 1日前

North, I happened to watch the Carson Block interview earlier in the day on CNBC. His short thesis is about ELF's inventory games with China. Very interesting Muddy Waters is one of the best shortsellers in the street since I was on the same side many years ago I totally understand the depth of research necessary to be successful. Why would the company wait till Cramers show to explain the redactions. I didn't see that interview but I would be leary re their explanation.
Re the second question about publishing an unredacted settlement with HIKMA/PBM/AMRN. Only if it's beneficial to our company should they pursue that issue in court. Would it be wise or worth the legal expense to push the envelope only if it's to Amarin's benefit? IDK that answer.
Since amrn is hard to borrow I doubt any HF would still be short at this price, too risky, they would be exposed to a buy-in if the price shot up.

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ralphey 2日前

Its booming ! Major announcement coming. Greenland soon to approve vascepa !

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CaptBeer 2日前

Hi Monk,
Your friend has an interesting podcast, but I'm not sure if Dr. Bhatt would want to appear on a medical commercialization platform especially since he's a board member of BMS. He might have an interest if your friend's platform was pure research and not commercialization. However, Dr. Bhatt is on LinkedIn, X and probably others where your friend can reach out for an audience.

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lizzy241 2日前

Giovinco, IIRC, at some point in the recent presentation Berg mentioned the company has requested a listing extension. So I guess it's been granted. Since they talked about that issue on the call the company isn't obligated to issue an 8K.

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Monk4444 2日前

Captain
Please look at this link. #1 Medtech Podcast, Omar is a friend.
He said he would love to have Dr. Bhatt on. Can you help facilitate this and or see if he might be interested in being on Omar's show? My email is tekrz@comcast.net.
https://www.linkedin.com/in/okhateeb/?midToken=AQEit0aY-_rRZQ&midSig=0zQgibtXwKybw1&trk=eml-email_member_message_v2-one_to_one_single_thread-0-null&trkEmail=eml-email_member_message_v2-one_to_one_single_thread-0-null-null-d6sy2~m3s49lf5~26-null-null&eid=d6sy2-m3s49lf5-26&otpToken=MTAwNzFmZTUxMDJhY2NjY2JlMmYwMmU5NDQxY2UzYjY4ZWM5ZDg0MTlhYTg4NTY5NzFjNDAxNmM0ZDVlNWJmOTg0ZGM5MzkwNGNlMmZiZjAzMDIyYmFjMzJjZDkwOWVmMDliZDdmYThiNWYzMjllMiwxLDE%3D

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CaptBeer 2日前

$AMRN Results from AHA Abstract 4140394: Substantial cardiovascular risk reduction with icosapent ethyl in patients with prior cardiovascular events regardless of coronary artery disease history: REDUCE-IT CAD

Let me count the Ways! (Number 20) in a continuum of MOA’s for the pleiotropic benefits of VASCEPA®/VAZKEPA®.

CONCLUSION: IPE demonstrated robust CV benefit in statin-treated patients with CV disease. Patients with and without CAD experienced large reductions in absolute and relative risk of CV events.

Repeat after me…..”It’s the EPA Stupid!”

https://www.ahajournals.org/doi/abs/10.1161/circ.150.suppl_1.4140394

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north40000 2日前

Allow for the possibility that an SEC filing of the settlement is in the works, but a leak of contents has occurred. Also allow for the possibility I made up the entire story that has confused you; I also may be erroneous in thinking that Centene is the parent of Hikma's PBM drug company.

The ELF story is real. ELF traded higher after hours Thursday evening. Let's see how it trades today. I own no shares of ELF.

I like the continuation of any unannounced FTC investigation of higher Vascepa scrip prices caused by collusive, deceptive practices of 2 generics in persuading the Nevada District to invalidate Amarin's 6 patents reflecting the results the Marine trial better anyway.

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Giovinco 2日前

frankly quite incredible there was no PR and no 8K about the extra 6 months they applied for confirming the 6 extra months beyond Nov 20, the new deadline is May 20 I guess, they didn't care to inform us

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