Amarin Corp PLC News - AMRN

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Amarin Announces Two Upcoming Investor Events

-- Company to Report Third Quarter 2024 Financial Results Wednesday, October 30 –- -- Amarin to Hold Virtual...

Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe

DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN...

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update

-- Cash Position of $307 Million Provides Stable and Strong Capital Foundation –-- Total Net Revenue of $68...

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...

Whalatane 7 hours ago

OT. but the facts
Republican South Carolina Gov. Henry McMaster said at a Tuesday press conference that federal assistance had “been superb,” noting that Biden and Transportation Secretary Pete Buttigieg had both called and told him to let them know whatever the state needed. McMaster added that the administrator of the Federal Emergency Management Agency, Deanne Criswell, had also called. He said, “So we’re getting assistance, and we’re asking for everything we need.”

Republican Virginia Gov. Glenn Youngkin said at a Monday press conference, “I’m incredibly appreciative of the rapid response and the cooperation from the federal team at FEMA.” He specifically thanked Biden, among others, in a press release the day prior.

Republican Tennessee Gov. Bill Lee said at a Wednesday press conference that the response to his emergency declaration “was quick from the federal government,” adding there was “a fast turnaround, frankly,” in making the state eligible for some federal reimbursements.

Kiwi

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rosemountbomber 8 hours ago

Sounds like the National Guard has been doing yeoman work from as soon as it was possible:

https://www.nationalguard.mil/News/Article-View/Article/3919179/national-guard-rescues-hundreds-of-people-in-wake-of-hurricane/

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rosemountbomber 8 hours ago

Hats off to your son and you as well.

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Monk4444 8 hours ago

I have been saying this for days send in the damn helicopters. These people are stranded. It took the current administration a freaking week to activate response.

God bless your son thanks for his service. What took Joe and cameltoe so long.??

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CaptBeer 9 hours ago

$AMRN off-topic, but my grandson is stationed at Ft Campbell, he’s a crew chief on a CH-47 Chinook helicopter. They’re on there way to NC to provide aid to those forks. Proud Grandpa!

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Number sleven 13 hours ago

MA52TA, Thanks. Maybe in the next few days.i went to the "Gazette" home page and did a search. Four publications came up from 2021-2023.
Sleven,

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MA52TA 13 hours ago

If you look at the publication dates, in the "Official Gazette", (on the left), 1-2-3-4-5-October. Every day they publish a part of it.
Maybe next week we'll see what we're looking for.

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Number sleven 14 hours ago

MA52TA, That's four sets of eyes. I'm willing to accept that it isn't there.
Sleven,

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MA52TA 15 hours ago

I don't see it either. Maybe it will be published in the next few days.

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Number sleven 16 hours ago

Skipperdog, Thanks. It might not be there.
Sleven,

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Skipperdog11 16 hours ago

for what it's worth, this third set of eyes could not find Vaskepa as well.

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Number sleven 17 hours ago

TCI1, Good catch. You might be right. I'll look for that as well.
Sleven,

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TCI1 17 hours ago

The approvals are all generics (Sandoz, Mylan, Teva, Dr Reddys, Hikma) - I don’t see any brands really so I wonder are there two separate documents

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Number sleven 17 hours ago

TCI1, Yes. I will try shifting through that mess again this evening. Unless someone else finds it.
Sleven,

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TCI1 17 hours ago

Assuming it’s definitely approved for reimbursement.

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Number sleven 17 hours ago

TCI1, I didn't see it either. It must be in there somewhere.
Sleven,

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TCI1 17 hours ago

Thanks Sleven. I don’t see Vazkepa on the list (although I might have missed it as it’s not reader friendly)

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abka 18 hours ago

Right, Still now I blame John Thero for current situation of Amrn. He hired some friend lawyers to fight in Vegas. JT should burn in hell.

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Number sleven 19 hours ago

http://95.110.157.84/gazzettaufficiale.biz/emittenti/elencoEmittente9.htm
Sleven,

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rosemountbomber 20 hours ago

Totally true. But I have to add that the random judge and random state was ultimately the result of management’s decisions.

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Jasbg 21 hours ago

We got played/killed by some smart generic loyers and a random judge in a random state.

So much the USPTO stamp - that Amarin spend more than a decade and hundred of millions getting'.

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alwayswatching1 2 days ago

CAPR having all the fun while we languish in hell. Maybe just maybe we have 1 more decent run for this POS stock to get us some of our money back. What a freakin nightmare this turned out to be.

https://www.marketbeat.com/instant-alerts/nasdaq-amrn-analyst-earnings-estimates-2024-10-04/

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ramfan60 2 days ago

Kiwi.....Nothing wrong with the numbers as you said. I did have excess body fat thanks to my Ben and Gerry's Covid diet so I managed to melt that off by avoiding carbs and burning fat for energy. That's what happens when you become fat adapted.

I stopped taking the Lisinopryl because my BP normalized

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Whalatane 2 days ago

Re Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80....what was wrong with that ?
About BP measurements ...you probably know about the white coat phenomenon . Suggest you have the BP measurement done at least twice while in the office ...just after you arrive and again just as you are about to leave . If you can stop by a place like Rite Aid on the way home for a self administered 3rd measurement , all the better .
Why no more Lisinopryl ?
Kiwi

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ramfan60 2 days ago

It will be interesting to see what my personal lab rat lipids look like in a couple weeks......as you may recall, I put myself on a super low carb way of eating. Mostly high fat meat, dairy, and eggs. Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80. My BP was hanging around the hypertension levels of 140/90 and they prescribed low dose Lisinopryl. At the 6 month mark, I had LDL=200, TRIGS = 48, HDL=89.......no more Lisinopryl as my BP hovers in the 120's/80s....... so I'll see the vampire next week and see what happens

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Whalatane 3 days ago

Ram. agree ...good pt . My wife prescribes Statins to her CKD patients ,( has prescribed Vascepa ) but also can't tolerate a high enough dose of a Statin to get her LDL below 70 mg/dl .
Kiwi

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ramfan60 3 days ago

Let's not forget, these indications assume a certain level of ability to tolerate statins....... a case can easily be made that a patient does not tolerate something.

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Whalatane 3 days ago

N7. You wrote I would imagine they can make the patient fit reimbursement criteria....which indicates intent to defraud ...filing incorrect data ( LDL levels for instance ) in order for Vascepa to be reimbursed.
That activity probably puts the MD at higher risk than prescribing off label .
JMO
Anyway ...if the story out of Italy was great AMRN would have PR'd it already .
Good news hits the wires almost instantly . Less good / indifferent news seems to get lost ...MITIGATE data for instance

Kiwi

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MA52TA 3 days ago

It's just paperwork... The reality is very different.

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seve333 3 days ago

Dead silence from denner and his fund. They have not said a word in six months. That is what I know.

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seve333 3 days ago

The stock is at .60 cents how much more damage can be done to it that denner has not already caused? The guy has proven to be a complete fraud in over his head. I guess he turned around a company once but its clear his lost his touch. The silence from his firm speaks volumes after they claimed how important communication was. To me they are complete liars who said whatever they had to simply to take control.

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CaptBeer 3 days ago

Here are some notables from this article:
https://kevinforeymd.com/reverseascvd/

How To Reverse Atherosclerosis: Strategies For Those With Coronary Artery Calcium (CAC)

1. Icosapent ethyl (VASCEPA®) can be effective in the reversal and regression of atherosclerosis (plaque), in statin treated patients regardless of their TG levels.
2. A 1% reduction in plaque volume is associated with an 18% reduction in major cardiovascular events.
3. Icosapent Ethyl plus Statin therapy achieved a greater reduction in total plaque volume as well as fibrous low-attenuation plaques, suggesting an additional plaque-stabilizing effect.

Below is my illustration comparing plaque regression to CVE Outcomes in statin treated patients plus alirocumab (PCSK-9) vs. Statin treated patients + VASCEPA®. You can easily see the relationship expressed in bullet point #2 in the RRR from these two therapies.

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Number sleven 3 days ago

JRoon, I stand by that opinion. Reimbursement isn't a label restriction. "If" a doctor wants to put a patient on Vazkepa, I don't believe restrictive reimbursement will create an insurmountable barrier.
Sleven,

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JRoon71 3 days ago

I would imagine they can make the patient fit reimbursement criteria.

That's what I was responding to.

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Number sleven 3 days ago

JRoon, You are responding to things I didn't write.
Sleven,

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JRoon71 3 days ago

You're also making a huge assumption that doctors are so emphatically moved by Vascepa that they are willing to push the envelope on script requirements and documentation in droves.

Since this has not happened in the U.S., Canada, the UK, or Spain, what leads you to believe that Italy is somehow different?

All of EU is approved for use, and more than a handful are approved for reimbursement with ZERO scripts written.

I would love to be optimistic, but there is zero evidence that any significant number of doctors, on ANY continent, are prescribing Vascepa like crazy. In fact, the opposite is happening - there are other drugs that are leapfrogging Vascepa in the standard of care regime.

Did you see what was written about Vazkepa by AIFA?

"Although demonstrated in comparison with a placebo probably not completely inert and in a population not treated on top of the drugs recommended for the reduction of LDL cholesterol, the data of the study seem to configure an important added therapeutic value. The certainty of these data, however, is not sufficient as detailed in the section on the quality of the evidence."

QUALITY OF TESTS: Low
COMMENT: The pivotal REDUCE-IT study, a randomized placebo-controlled trial, was considered in the GRADE_Pro assessment. The lack of reproducibility of the results (the only study with results not consistent with those of other drugs in the same class) and the lack of generalizability (patients not treated on top of the drugs recommended for LDL-C reduction and in the absence of information regarding any dietary control) determine the application of two downgradings to the quality of the evidence which is therefore to be considered LOW.
OVERALL JUDGEMENT ON INNOVATION: The drug is not recognized as innovative in light of its moderate therapeutic need, significant added therapeutic value, and low quality of evidence.

This is what doctors are seeing in Italy

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MA52TA 3 days ago

It's just paperwork... The reality is very different.

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Number sleven 3 days ago

Kiwi, Is Italy part of the EU? Italian reimbursement decision will not alter the label.
Sleven,

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DMC8 3 days ago

https://kevinforeymd.com/reverseascvd/

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DMC8 3 days ago

https://www.dispensingdoctor.org/news/dda24-reducing-cv-risk/

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Whalatane 3 days ago

Absolutely no risk ?

When prescribing off-label medications in Italy, physicians have several important liability considerations:

Legal Framework
The main law governing off-label prescribing in Italy is Law 94/1998 (also known as the Di Bella Law)1. This law allows off-label prescribing under certain conditions:
It must be for an individual patient
The physician must determine that approved on-label medications cannot effectively treat the patient's condition
There must be scientific evidence supporting the off-label use, including favorable results from completed phase II clinical trials
The patient must provide informed consent

Physician Liability
When prescribing off-label, Italian physicians take on increased responsibility and potential liability:
They have a direct responsibility for the off-label prescription3.
They may be called to respond to any problems arising from the off-label use as if they had done something outside the standard of care1.
The burden of proof rests on the physician to demonstrate the off-label use was appropriate1.
Key Liability Considerations
To mitigate liability risks, physicians should:
Thoroughly document the rationale for off-label use and scientific evidence supporting it
Obtain and document informed consent from the patient, clearly explaining the off-label nature of the prescription4
Closely monitor the patient for adverse effects
Stay up-to-date on the latest evidence and guidelines regarding off-label uses

Potential Consequences
If problems arise from off-label prescribing, physicians may face:
Administrative liability
Potential requirement to personally reimburse costs
Professional disciplinary action
Civil liability claims from patients
However, if proper procedures are followed, off-label prescribing is legally permitted and can be an important treatment option2.

The key is ensuring it is done responsibly with appropriate documentation and patient consent.. my emphasis ...just what MD's want everywhere ...more paper work

Kiwi

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MA52TA 3 days ago

Absolutely no risk. Completely different from the USA.

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MA52TA 3 days ago

I think he has a lot of discretion to prescribe. I know how it works, I am Italian, even if I currently live abroad. Of course, either the doctor or the patient must be informed of the benefits of prescribing VAZKEPA.

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Whalatane 3 days ago

N7. Theres plenty of risks...to the MD .... in doing what you appear to be advocating .
I wouldn't count on it
Kiwi

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Number sleven 3 days ago

JRoon, I agree that reimbursement is the important piece. If doctors want the patient to receive the medication, they will work the system. I have no doubt they have experience.
Sleven,

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Number sleven 3 days ago

RMB, If an Italian doctor wants his/her patient to be on a particular therapy, how much latitude do you think they have. I would imagine they can make the patient fit reimbursement criteria.
Sleven,

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Amarin Corp PLC (AMRN)

Empower your portfolio: Real-time discussions and actionable trading ideas.

AMRN News

Amarin Announces Two Upcoming Investor Events

Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe

Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update

Form 8-K - Current report

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

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

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

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

AMRN Discussion

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Amarin Corp PLC (AMRN)

Empower your portfolio: Real-time discussions and actionable trading ideas.

AMRN News

Amarin Announces Two Upcoming Investor Events

Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe

Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update

Form 8-K - Current report

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

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

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

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

AMRN Discussion

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