Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
anything less than $13bn or $14 bn is probably a non-starter....just my guess.
$30 share price level probably minimum.
I doubt JT & the Board & the Baker Brothers would even seriously consider $20, which if 416 mm is the fully diluted share count gets you to $8.3 bn.
I don't know what number it's going to take, but I doubt it's $8 bn.
Europe plus China plus any bump from COVID....one would have to think a BP sees more than $8 bn in value here...and this does not even factor in the USA.
I don't see the Board considering $8 bn.
The Board and management must see the stock price everyday like we do and the precipitous decline in value.
I would be shocked if they are just sitting on their hands.
JT owns more shares than anyone on here so one would think he would be motivated to maximize value too.
He mentioned M&A during a previous webcast with one of the analysts.....was that a subtle message....time will tell.
We also had a Board Member who purchased shares in October. Joseph S. Zakrzewski I wonder why he bought....
https://investor.amarincorp.com/static-files/a28b578c-e7e3-4d03-b560-08d71b40d57e
If there is any ray of hope, it's that there is so much negativity / pessimism built into the current situation....the market already thinks the US is lost and does not have faith in our current plans for Europe hence our current stock price. So surprises here could do wonders.
Yep but January is coming...JP Morgan Healthcare Conference.
Let's see what JT has up his sleeve.
Baker Brothers are still holding for a reason.
Give us something JT......
Great point!
I guess those "institutional investors" know more about JT's plans and what's in store......
Even by the time that case would be fully litigated, we would be approaching the end of REDUCE-IT patents in USA.
I'm sure Amarin would select a jury trial the second time around too.
Great post!
Another article in today's WSJ about long-haulers, COVID-19, and new treatments and no mention of Vascepa.
For months, Covid patients suffering from debilitating long-term symptoms have gotten few answers—and even fewer treatments—from the medical community. But now, some pharmaceutical companies and researchers are moving to launch the first clinical trials for drugs intended to treat long-term Covid.
Many Covid long-haulers, as they are known, are young and were previously healthy, and weren’t hospitalized for their initial infection. But months later, many are experiencing life-altering symptoms including brain fog, extreme fatigue and shortness of breath, often making normal daily activities nearly impossible.
Doctors’ understanding of the condition is still nascent, and estimates for cases vary widely. But research suggests at least 10% to 20% of Covid patients experience long-term symptoms. A recent survey from the U.K.’s Office for National Statistics, for instance, reported that at least 10% of Covid patients have symptoms lasting for three or more months.
Companies are repurposing experimental drugs being tested for other diseases, and filing applications or launching clinical trials. Some are using the treatments on patients who apply for compassionate use when possible.
So far, these drugs are experimental and are not yet FDA-approved for any condition, whether Covid or any other disease they were originally developed to treat.
Doctors have previously used some existing drugs to alleviate specific symptoms of long Covid in a piecemeal fashion. What’s different now is that scientists are testing drugs intended to treat the underlying causes of the condition.
CytoDyn, a Vancouver, Wash., biotechnology company, recently applied to the U.S. Food and Drug Administration to test its experimental drug, leronlimab, on 102 long Covid patients, says Scott A. Kelly, chief medical officer of the company.
Leronlimab, a monoclonal antibody administered through subcutaneous injections, was developed as an HIV drug. When the pandemic hit, the company shifted to Covid-19. The same receptor that allows HIV to enter cells is also important in regulating immune cells; some doctors believe long-term Covid symptoms are caused by the immune system going haywire. The company has recently tested the treatment in severe Covid patients as well as in mild to moderate cases, some of which were long-haul patients.
Some patients with long-term symptoms reported their brain fog and cognition issues improving after treatment. “When we started to see these patients saying the brain fog was clearing, we were encouraged,” says Dr. Kelly. A new trial would test the drug specifically on long-haul patients.
Dr. Kelly says they believe leronlimab may be alleviating brain inflammation. Leronlimab binds to a cell receptor that contributes to the regulation of immune cells that sometimes flood an area and destroy tissue. Blocking that receptor may slow down the inflammatory response, which some scientists believe is triggering problems in long Covid patients.
“We are hopeful we can control the neuroinflammation in the brain which we think causes a lot of these problems with autonomic dysfunction, fatigue, brain fog,” says Dr. Kelly. The company says patients haven’t reported significant side effects in the clinical trials they’ve done for Covid and HIV.
Dr. Kelly says the interest in such a treatment is tremendous. “I get emails every day about wanting to participate in the trial,” he says.
Related Video
Covid Long-Haulers Fear for Their Future
You may also like
Up Next
Covid Long-Haulers Fear for Their Future
A significant number of Covid-19 patients are dealing with symptoms long after the initial infection. The Wall Street Journal asked four patients to share their stories about how lingering effects are affecting their lives.
Among them is Patrick Varnes, a 41-year-old financial director in Atlanta who was diagnosed with Covid at the end of June. Nearly six months later he continues to have shortness of breath, fatigue and headaches. “I’ve had shortness of breath every single day,” says Mr. Varnes.
Before Covid-19, Mr. Varnes was a fitness buff. He went to a CrossFit gym five days a week. Now, he can’t do much more than go on a walk.
He heard about leronlimab from an online support group and reached out to Christopher Recknor, a Gainesville, Ga., physician who runs clinical trials for CytoDyn. Mr. Varnes did a pre-screening; if the FDA approves a trial, he’ll be able to join it, says Dr. Recknor.
Mr. Varnes says he’s tried nearly 30 different supplements, acupuncture and a steroid. “After six months of living in an internal prison, I need to try it,” says Mr. Varnes. “I really, really hope it works.”
Other companies are also repurposing drugs investigated for other conditions.
Organicell, a Miami-based biotechnology company, is looking at testing Zofin, an experimental drug tested for chronic obstructive pulmonary disease, or COPD, on long Covid patients. Zofin uses nanoparticles to reduce inflammation and microRNA to target different genes.
Mari Mitrani, chief science officer of Organicell, says the company decided to pivot to Covid-19 because Zofin was designed to improve lung regeneration, which is a problem for many Covid-19 patients.
The drug has been used in 18 Covid patients—including four with long Covid—through compassionate use requests approved by the FDA. The company received FDA approval to do a trial for certain groups of recently infected Covid patients. It is waiting for FDA authorization to do a trial specifically for long-haul Covid patients, says Dr. Mitrani. Organicell says no significant side effects have been reported so far.
PureTech, a Boston-based biotechnology company, is also looking to test LYT-100, its experimental drug, to treat lung-scarring in post-acute Covid patients.
Toby Maher, a professor of medicine at the University of Southern California, is principal investigator of a study testing the use of LYT-100, an anti-inflammatory drug. Dr. Maher is overseeing a Phase 2 clinical trial starting to recruit 168 patients who are at least one month post-hospitalization, but are still having difficulty breathing and whose lung scans show residue of disease.
LYT-100 is an oral tablet taken twice a day. The company says the main anticipated side effects are gastrointestinal issues such as bloating and nausea, but says most patients should be able to take the treatment without problems.
“Increasingly we’re recognizing there are a large number of patients left with significant symptoms following Covid infection and those symptoms appear to be caused by permanent damage to the lung in the form of scarring,” says Dr. Maher.
Some doctors believe that some long-haul Covid patients are suffering from myalgic encephalomyelitis/chronic fatigue syndrome, a post-viral condition. AIM ImmunoTech, an Ocala, Fla., biotechnology company, recently got approval to expand its ongoing clinical trial for CFS to include Covid patients who have chronic fatigue-like symptoms, says Tom Equels, CEO of the company. The company is treating patients with Ampligen, an experimental antiviral drug administered as an IV infusion.
The company says Ampligen has been generally well tolerated, with the most likely side effect being mild and transitory flu-like symptoms. It works by activating and enhancing the natural human immune system.
An October study published in the journal PLOS One found that the earlier ME/CFS patients take Ampligen, the better the outcome, says Mr. Equels. “We have a unique opportunity here with the Covid long-haulers to catch the chronic disease at the early stages of the disease,” he said.
Maybe they should advertise on CNBC first. Spend some ad dollars to get a mention......
It’s truly sad and mind boggling how little people know about Vascepa.
New Strain in UK - Article in WSJ
LONDON—The U.K. imposed a fresh lockdown across London and surrounding areas of England to combat a new strain of coronavirus that appears to be significantly more contagious than earlier variants of the pathogen.
Scientists say the new variant might be as much as 70% more transmissible than more established strains, Prime Minister Boris Johnson said at a news conference Saturday. Though it transmits more easily from person to person, there is no evidence it is any more deadly or resistant to vaccines, he said.
The new lockdown means many families won’t be allowed to gather for Christmas. Mr. Johnson, who only days ago said it would be “inhuman” to put curbs on Christmas celebration, said: “It is with a very heavy heart, that I must tell you we cannot continue with Christmas as planned.”
The new restrictions cover the capital, as well as much of southeastern and eastern England. In London, the new strain of the virus accounted for 62% of the new cases identified in the week through Wednesday.
Similar steps have been taken across Europe to beat back rising caseloads. In Italy, Prime Minister Giuseppe Conte announced Friday a total lockdown across the country for the first time since May to be in force over Christmas, from Dec. 24 until Jan. 6.
In London and its environs, nonessential stores must close and people must stay at home from midnight Saturday, with limited exceptions for some types of work and essential shopping, Mr. Johnson said. Places of worship will remain open.
Households are barred from mixing at Christmas and people are banned from visiting other regions, in an effort to stop the strain being seeded elsewhere in the country.
“When the virus changes its method of attack, we must change our method of defense,” Mr. Johnson said.
Across the rest of England, Scotland and Wales, households will only be allowed to mix on Christmas Day instead of over a five-day period that the government had previously announced.
The nation reported 27,052 new daily infections Saturday, taking the total number of known cases in Britain to more than 2 million. There are currently almost 19,000 people in hospital with Covid-19, and the country has reported more than 400 deaths a day on average over the past seven days.
The U.K. became earlier this month the first Western country to begin vaccinating people with a clinically approved vaccine. Mr. Johnson said 350,000 people had now received shots. That compared with more than 137,000 on Dec. 15.
The country reported its discovery of the new strain Monday and has already notified the World Health Organization.
Scientists have identified around 23 differences in its genetic material to established strains. Those include changes in areas known to be associated with how the virus binds and enters cells, which might explain why it spreads more quickly, said Patrick Vallance, the U.K. government’s chief scientific adviser.
He said it has already become the dominant strain in parts of England, displacing older variants. “This virus is taking off, it’s moving fast and it’s leading inevitably to a sharp increase in hospital admissions,” he said.
Scientists also said the increased transmissibility of the strain could increase R—the number of people on average every person with the infection goes on to infect—by 0.4 or more. The latest estimate of R across the U.K. is 1.1 to 1.2.
U.K. officials said it isn’t clear where the variant emerged—though it was possibly in the southeastern country of Kent, which abuts London—or whether it is present abroad. They said its virulence might explain why the restrictions that have been effective in other parts of the country in bringing down case rates hadn’t done so in Kent.
They said precautions to slow the spread of the virus, such as keeping two meters away from people, wearing a face mask and frequently washing hands, should continue to be followed.
Viruses replicate quickly and mutations are common due to tiny errors in copying genetic material, which can accumulate over time, giving rise to new variants that can behave slightly differently to older strains.
Scientists world-wide have since the beginning of the pandemic been tracking these genetic changes. More than 1,000 variants of the virus that causes Covid-19 have been detected so far.
The new variant isn’t the first time a more-transmissible strain has emerged. Scientists in July described a variant that over time displaced an older strain of coronavirus to become the dominant strain in the global pandemic. Experiments showed that variant, known as G614, replicated more quickly, but appeared to be just as susceptible to antibodies that target the earlier strain and wasn’t associated with more severe illness.
Much of Europe’s new wave over the summer, meantime, was traced to outbreaks among agricultural workers living in cramped conditions in Spain’s Catalonia and Aragón regions. Researchers from Switzerland and Spain identified a variant known as 20A.EU1 that from there spread to nearby cities and across Europe by returning tourists.
In Italy, where the government on Friday reported 674 deaths from Covid-19, the hardest-hit areas are the northern regions of Lombardy, Veneto and Piedmont. But the southern region of Campania, which includes the city of Naples, is now one of the five most-affected regions.
A maximum of two guests will be allowed in every home during the period, but the limit won’t apply to children under the age of 14. Bars, restaurants and nonessential businesses will be closed. A curfew already in effect from 10 p.m. to 5 a.m. will continue to apply.
Unlike during the spring surge, churches will remain open, albeit with limited capacity subject to social distancing.
Elsewhere in Europe, Germany and the Netherlands have imposed lockdowns through Christmas, and Austria said Friday that nonessential businesses will be closed starting Dec. 26.
—Francis X. Rocca contributed to this article.
Write to Jason Douglas at jason.douglas@wsj.com
En banc at the CAFC is extremely rare these days. If en banc is granted, that's a signal to the Supreme Court.....hey this case is of importance and you should look into it.
Is the makeup of the Supreme Court more conservative or democratic? The Supreme Court favors Newman. That's a fact. They know she is the expert on patent issues. So let's assume it gets overturned on en banc...the Supreme Court is next. This case will be tied up for quite a while. In theory, this should benefit Amarin because the uncertainty / risk is on the generics given the amount of damages. Singer and team know this. The Supreme Court has a history of cleaning up the CAFC's mistakes on patent issues.
Judge Newman is no slouch. She wrote her opinion to withstand scrutiny.
Got it. Thank God for Judge Pauline Newman. She is 93.
The Supreme Court has a lot of respect for Judge Newman.
Having the same lawyers (Singer) is truly great because even though there is attorney client privilege (wink wink), Singer can still fill JT in on that case and strategy etc. It's truly great in this regard.
Does Amarin even have a gov. relations person who is trying to drum up support in this effort to reach elected officials regarding this matter....
what is the company doing?
Correct. It usually pops earlier in the week to dupe folks into buying the weekly calls then come Friday it closes at or around $5. Like clockwork. With no news coming it's easy to carry this out.
Understood, thanks!
Thanks for the update. Hope this gets moving soon. Shareholders are due for some good news.
Are you shocked JT has not made the media rounds about COVID-19 and Vascepa?
Hope you are right. The lack of any press or media rounds from our CEO on our initial COVID news is frustrating beyond belief.
Coronavirus Czar is Jeffrey Zients. He is leading Biden's task force on tackling this virus. I wonder if he even knows about Vascepa or if someone has shared initial findings with him on Vascepa. Hopefully Dr. Bhatt or someone has reached out to him.
Article from the WSJ
WASHINGTON—A crisis awaits Jeffrey Zients.
By the time he starts as President-elect Joe Biden’s coronavirus czar, an estimated 400,000 people in the U.S. could be dead from the pandemic. Millions of vaccine doses will need to be administered by states, and the nation will remain split over the best way to confront the virus.
Mr. Zients, an investor and former Obama administration economic adviser, has tackled health-related organizational challenges before. He is credited with turning around the bungled rollout of the Affordable Care Act’s HealthCare.gov website in 2013.
“Like now, it was a very high stakes situation with an uncertain outcome,” said Denis McDonough, the White House chief of staff during the Obama administration’s second term who is now Mr. Biden’s pick for veterans affairs secretary.
U.S. Health-Care Workers Receive First Doses of the Covid-19 Vaccine
On Monday, over 50 hospitals and health departments across the country received the newly authorized Covid-19 vaccine developed by Pfizer Inc. and BioNTech. Health-care workers were among the first to be vaccinated in the U.S. Photo: UPMC
The pandemic’s scale means the challenge now is bigger. And while he draws praise from officials who worked with him during the Obama years, his selection has been criticized by some progressive Democrats leery of his business background: He is on leave from his job as chief executive of investment firm Cranemere and served on the board of Facebook Inc.
Jeff Hauser of the liberal Revolving Door Project, which scrutinizes executive-branch appointments, derided Mr. Zients as friendly to corporations and raised concerns about his previous work in the health-care industry. Mr. Zients served as chief executive of the Advisory Board Company, a health-care consulting and research firm.
“Our worries in this specific job are that he is not only comfortable with the financialization of American health care, he has hastened it,” Mr. Hauser said. “And we think that the person who runs the Covid-19 response is going to be shaping public policy in some very consequential ways as to how the government interacts with health-care providers.”
Mr. Zients also lacks public-health experience, raising concerns among some in Congress, though his position won’t require Senate confirmation.
“If you had that public health background, then you’re able to prioritize competing priorities—which is more important or not—because you know from a public health background which one’s a linchpin and which one can wait,” said Louisiana GOP Sen. Bill Cassidy, a physician.
Mr. Zients declined to comment, according to a spokesman with the Biden transition team. Supporters say critics should look at his success stabilizing HealthCare.gov as evidence he can make strides in corralling the pandemic.
Frustration ran high in October 2013 when the online platform to sign up for individual health insurance under the ACA tried to launch. By most accounts, it was a mess. The website crashed after just two hours, and later could only handle about 35,000 visitors at any one time.
Less than two weeks after the troubled start, Mr. McDonough took Mr. Zients for a walk on the White House South Lawn. He had known Mr. Zients, who had been acting director of the Office of Management and Budget in 2010 and 2013, and coaxed him to lead a mission aimed at fixing HealthCare.gov.
Mr. Zients had no experience in the technology industry, having worked primarily in management consulting before joining government. But, as will be the case when he takes his new job in January, there was a need to act quickly. Scores of people were unable to create an application on HealthCare.gov, and there was a narrow window for them to sign up. The federal government had spent more than $80 million, and additional costs were adding up.
First, Mr. Zients marshaled private companies and technology firms to undertake a rapid review of HealthCare.gov’s problems, drafting a punch list of fixes to prioritize. The quick action didn’t surprise people who had worked with him before.
“He’s not a ditherer,” said Richard Cordray, the first director of the Consumer Financial Protection Bureau from 2012 to 2017.
Mr. Zients publicly committed to operations working smoothly by late November and made the Centers for Medicare and Medicaid Services, which oversaw the ACA implementation, accountable by holding regular press briefings, said Andy Slavitt, who served as the agency’s acting administrator during the Obama administration.
“He organized the briefings with slides and materials every week, with all the data,” said Mr. Slavitt.
A similar public-information effort will be needed when Mr. Biden takes office to reassure people about the vaccine’s safety and provide updates on initiatives to slow the virus’ spread, health leaders say. The current White House coronavirus task force has been largely sidelined and no longer provides regular press briefings.
When he was focused on HealthCare.gov, Mr. Zients realized many contractors were working on different parts of the platform rather than working together. He selected a single general contractor, QSSI, a division of UnitedHealthGroup, even though the decision risked the ire of other vendors.
Similarly, the coronavirus response will need a clear command structure, public-health leaders say, to make sure federal agencies are working in concert with each other and states.
Mr. Biden has called for broad changes to the federal response to the coronavirus and pressed people to commit to wearing a mask for 100 days. He has said he would back a mask mandate on federally owned property, widen free testing and put public-health scientists in the forefront. He wants 10 mobile testing sites and drive-through facilities in each state and has said he would deploy military resources to boost health-care capacity.
Mr. Zients, 54 years old, will have to implement the initiatives and get up to speed with what the Trump administration has already put in place.
“These are hard issues,” said Dr. Tom Frieden, the former director of the Centers for Disease Control and Prevention. He said the challenges existed in part because the Trump administration had left states shouldering much of the response rather than taking a more muscular federal approach.
Mr. Zients will need to understand an enhanced tracking system for personal-protective equipment to hospitals and nursing homes, allocation of Covid-19 therapeutics, domestic production of supplies such as gloves and masks compared with demand, and the current state of contact-tracing systems set up by states and what role the federal government should play.
“I think what folks across the political spectrum need to understand is the reason why he’d be good at this job—and I presume the reason why he’s been chosen—is that he’s a superb manager, who now after eight years in the Obama administration understands the levers of government as well as anybody,” said Josh Bolten, president and CEO of Business Roundtable and former chief of staff to President George W. Bush.
Mr. Zients is a father of four children who lives in Washington, D.C. He lifts weights and enjoys a good bagel; he is a co-owner of Call Your Mother, a popular deli.
He notched successes during his tenure fixing HealthCare.gov. By late November, about 90% of people who visited HealthCare.gov to make an application were able to do so. He invited Obama staff going back eight years to a party at a northern Virginia theater to thank everyone for their hard work.
Not sure. I don't think one can read too much into it.
Great point. Yep, same legal team for GSK and Amarin.
PACER
No but that was different. Amarin lost with 3 votes against it.
GSK v. Teva was 2 to 1.
Today's sell off may be related to the appellate court inviting GSK to respond to Teva's request for an en banc hearing. It's hard to read more into this request as these requests happen from time to time.
For instance the court invited the other side to respond in the American Axle case before denying an en banc hearing some 7 months later.
One thing is clear: GSK v. Teva will be tied up in the courts for months if not years to come. Because the loser will likely appeal to the Supreme Court.
American Axle was case 18-1763 for those interested in seeing the timeline. Of course GSK v. Teva situation could be different but these things take time. This is not the only case the appellate court has on its plate.
Cramer knows a little about a lot of stocks. I doubt he is as well versed on Amarin as most of us on here are.
You think Teva gets an en banc hearing?
Wow. Thanks for sharing. Amazing the media is so in love with Moderna's vaccine.
Thanks for sharing. So are you going to take the mRNA vaccine?
Management needs tremendous help in getting the word out about Vascepa.
Dr. Bhatt on the webcast this morning said implementation (making folks aware) is another issue.
What good is having a great therapeutic if very few know about it.
Apparently new jobs are being posted today for Europe. See stocktwits Steve_thebull_rogers put up a screenshot.
Buying in Afterhours too - The European meeting must have gone well.
https://pharmajobs.co.uk/job/medical-science-liaison-cardiovascular-2/
https://www.totaljobs.com/job/market-director/ashfield-healthcare-limited-job91415612
https://www.totaljobs.com/job/medical-director/ashfield-healthcare-limited-job91415057
https://www.totaljobs.com/job/general-manager/ashfield-healthcare-limited-job91414807
Hi Phamracydude what do you make of this
https://www.the-scientist.com/news-opinion/the-specter-of-endothelial-injury-in-covid-19-68121
Does this seem to align with your theory of the pleiotropic effects of Vascepa?
Thanks for sharing.
What do you mean by that? Please explain. Thanks.
Continuing to lock up supply and let a BP (acquirer) take over the litigation for Amarin may be the best move for all here. Shareholders have suffered enough.
Interesting re: Europe. JT stated approval is expected early part of next year. So does a BP let Amarin handle the country negotiations for reimbursement....meaning would a potential acquirer be comfortable with Amarin handling these negotiations once approval starts the timeclock or would the BP rather drive the bus so to speak with these country by country negotiations....?
Hmmmm
You are assuming that other generics are going to want to enter this quagmire. Teva has its own issues with GSK right now. They may think otherwise about getting into this battle. If that case stands, you think a judge or jury will take it lightly that Teva engaged in similar action with another pharma.
Dr. Reddy's may come to the same conclusion as well. Because of GSK v. Teva generic entry and sleeping well at night for the generics is no longer a given. Based on the Judge Newman's ruling in GSK v. Teva, one generic could be responsible for all the lost profits.
There is a lot of uncertainty here but that uncertainty could cost generics a lot of money. Then on top of that you have Amarin suing Hikma.
When was this posted / published?
Perhaps share it with Amarin management.
Exactly! You nailed it. The uncertainty for them is the huge risk. If Hikma's wrong / found liable, it's game over.....
Meanwhile there is discovery for us and we get to sit back and see what the volume / scripts look like.
Teva is fully aware of the what damages look like.