Ich bin sehr zuversichtlich dass der Appeal erfolgreich sein wird, eine Jury mit 3 hoffentlich unabhänigen Richtern/innen die Ahnung von der Sachlage haben sollen, werden feststellen das "honorable judge DU" factual and procedur erros gemacht hat..... Yes we hope....
Traurig, dass es soweit kommen musste, aber wo es um viel Geld geht, ist immer Korruption..... dabei
daß..... "It's confirmed the new lead counsel will be Fish & Richardson, on Forbes list of america's top law firms...." Search on PACER April 21, 2020 "Entry of appearance for Jonathan E. Singer as principal counsel for Appellants Amarin Pharma, Inc."
WENN dem wirklich so ist : Mr. Singer is annually named one of the nation?s finest life sciences trial attorneys and is an expert in proceedings under the Hatch-Waxman Act. His clients consistently praise his innovative and ground-breaking work and over the past two decades, he has successfully handled dozens of cases covering all aspects of the life sciences. In addition to his courtroom work, Mr. Singer regularly teaches life sciences trial and patent practice courses in the U.S. and Europe.
"Forbes list america's top corporate law firms" "Last month, Fish was named one of three elite "IP Litigation Powerhouses" in the prestigious BTI Litigation Outlook 2020 survey. Fish was the only firm to appear on the list in two consecutive years. Fish was also named one of 10 "Awesome Opponents" in BTI's list of the "Most Feared Law Firms in Litigation." The BTI survey is based solely on in-depth telephone interviews with leading litigation decision-makers at large organizations with $1 billion or more in revenue."
Perkins Coie ist damit für mich noch nicht gegessen und eigentlich mein Favorit. Oder WAREN diese bisher tätig für Amarin ? Weiß jemand von den Mitlesenden hier mehr ? Ich halte die Wahl der Rechtvertretung für enorm, enorm wichtig...
2 Top Biotech Stocks Under $10 Amarin and Atara Biotherapeutics could both be diamonds in the rough. George Budwell George Budwell (TMFGBudwell) Apr 27, 2020 at 7:56AM Author Bio
Stocks priced below $10 a share can be a mixed bag. Low share prices are often indicative of companies with poor fundamentals, a weak near-term outlook, and a large number of outstanding shares. These types of equities, in turn, tend to be exceptionally risky and highly volatile from a price standpoint. But there are a few significant upsides to buying stocks in the $5 to $10 range.
Low-priced equities, on occasion, can deliver substantial returns on capital within an exceedingly short period. What's more, it's far easier to build a position in round lots of 100 shares at a time. By doing so, investors can reduce their risk profile and generate immediate cash from the position by selling call options. While selling calls can cap the maximum return from a low-priced equity, this strategy also ensures that you won't walk away empty-handed in a worst-case scenario. A man wearing sunglasses while throwing money into the air.
Image source: Getty Images.
Which companies with share prices under $10 should investors be paying attention to right now? Two of the best low-priced equities at the moment are Amarin (NASDAQ:AMRN) and Atara Biotherapeutics. (NASDAQ:ATRA). These two biotech stocks have been heating up over the course of April and both are seemingly undervalued relative to their long-term outlook. Here's a snapshot of the pros and cons of each company. Amarin: A bet on a full-blown comeback
Amarin is a single-product, commercial-stage biopharma. The company's value proposition thus begins and ends with its prescription omega-3 treatment Vascepa. Last year, the drug gained a major label expansion as a treatment for patients taking statins but who are still at risk of cardiovascular disease. This new indication was thought to be worth at least $2 billion in annual sales, and possibly quite a bit more. Unfortunately, a U.S. District Court stripped Vascepa of its patent protection in March, causing Amarin's shares to collapse.
Thanks to the growing optimism that this decision will be overturned upon appeal, Amarin's shares have gained 88% in the nearly four weeks since this adverse ruling. This rapid recovery has also been fueled by the fact that Vascepa could still achieve blockbuster status, regardless of this patent ruling, due to its healthy commercial opportunity in former U.S. territories.
What are the risks and rewards? With a successful appeal in hand, Amarin's shares should rise by at least another 70% from current levels in light of where this stock was trading prior to this black swan event. If this appeal fails, however, Amarin should ultimately settle at around $8 a share -- based on Vascepa's commercial opportunity in the former territories and the average pre-pandemic premium for a commercial-stage biopharma stock. So, even in a worst-case scenario, Amarin's shares are arguably still undervalued right now. Atara: A make-or-break moment is on the way
Atara is a cell-based immunotherapy company. The company's main selling point to investors is its leadership position in the field of off-the-shelf T-cell therapies for cancer, autoimmune disorders, and viral infections. Atara's strategy centers around launching the first off-the-shelf T-cell therapy, dubbed tab-cel, for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease as soon as next year. A regulatory filing for this first-of-its-kind therapy is slated for the second half of 2020.
Although tab-cel's peak sales are expected to be rather modest at around $140 million a year, the company's second product candidate, ATA188, could be a megablockbuster as a novel treatment for patients with progressive multiple sclerosis. What's more, Atara's buyout value should skyrocket if its cell-based platform is validated with a successful regulatory filing for tab-cel. There are several big pharmas and blue-chip biotech companies racing to develop similar technologies after all.
What's the risk? While Atara does have the inside track for becoming the first company to bring an off-the-shelf T-cell therapy to market, there's also no guarantee that this novel therapy will get a green light from regulators. That's a significant risk factor to be sure. Atara's shares, in short, will surely take a huge step backward if tab-cel stumbles in the clinic or fails to win over regulators. On the flip side, this small-cap biotech stock does have the potential to double (or possibly triple) in value in the event that tab-cel does live up to expectations.
Bottom line: Atara is the epitome of a high-risk, high-reward clinical-stage biotech stock. Invest accordingly.
Amarin to Report First Quarter 2020 Results and Host Conference Call on April 30, 2020 [GlobeNewswire] GlobeNewswire?April 28, 2020
DUBLIN, Ireland and BRIDGEWATER, N.J., April 28, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) today announced that it will host a conference call with members of Amarin senior management to discuss the company's first quarter 2020 financial results and provide an operational update on Thursday, April 30, 2020, at 7:30 a.m. ET. The conference call will follow the anticipated release of the company's financial results earlier that day.
Conference Call and Webcast Information:
Amarin will host a conference call April 30, 2020, at 7:30 a.m. ET to discuss this information. The conference call can be heard live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8133 within the United States, 201-689-8040 from outside the United States, or by using the call back feature at https://bit.ly/2Knoe4L. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010, PIN: 34453. A replay of the call will also be available through the company's website shortly after the call.
To Ask Questions:
During the teleconference, following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations. Participants in the live teleconference will be provided an opportunity to ask questions. Investors may also e-mail their questions to firstname.lastname@example.org. Email questions will be accepted until Wednesday, April 29, 2020 at 4:00 p.m. ET.
Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin?s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit www.amarincorp.com.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin?s investor relations website and may include social media channels. The contents of Amarin?s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Investor and Media Inquiries: Elisabeth Schwartz Investor Relations Amarin Corporation plc In U.S.: +1 (908) 719-1315 email@example.com (investor inquiries) PR@amarincorp.com (media inquiries)
Lee M. Stern Solebury Trout In U.S.: +1 (646) 378-2992 firstname.lastname@example.org
Anal-ysten erhöhen nach einem Monat das Kursziel auf das Doppelte, es scheint als hätten sich die Klienten zum Teil eingedeckt, Dreckspack:
Citi doubles Amarin price target to $12 ahead of appeal decision Citi analyst Joel Beatty doubled the firm's price target on Amarin to $12 from $6 and keeps a Buy rating on the shares. The stock closed Thursday down 65c to $7.61. Beatty sees a "relatively high likelihood" of share upside from a European partnership in the second half of 2020, and also believes competitors are unlikely to launch a generic version of Vascepa before the appeal decision expected by the end of the year. While acknowledging a high risk to the stock from the appeal decision, he believes his 20%-40% probability of success on appeal for Amarin still provides a "favorable enough risk/reward" to buy the stock at the current price. Shares of Amarin are worth $24 on an appeal win, and $7 on a loss, Beatty tells investors in a research note.
Amarin hired good attorney for Vascepa appeal, says H.C. Wainwright 07:14 AMRN H.C. Wainwright analyst Andrew Fein believes Amarin (AMRN) hired a good attorney for the Vascepa patent litigation appeal process in Jonathan Singer, head of the life sciences litigation practice at intellectual property litigation leader Fish & Richardson. In consultation with a patent attorney, Fein learned that Singer has tried several high profile cases, including being on the team that won an appeal on behalf of Gilead Sciences (GILD) regarding the hepatitis C drug sofosbuvir, in which the judge overturned a $2.5B jury verdict and the Federal Circuit affirmed. The analyst reiterates a Buy rating on Amarin with a $51 price target. While Fein thinks Vascepa growth can continue in the near term, he believes the combination of in-person Vascepa sales calls being suspended and reduced patient visits to physician offices amid the COVID-19 pandemic can have a continued impact on new prescriptions looking ahead to Q2.
Nicht nur Wainwright sieht großes Potential, auch Roth Capital sieht Amarin als "strong buy" mit einem Kursziel von US Dollar 31, also 4-5 Bagger:
Amarin a 'strong buy' ahead of federal circuit ruling, says Roth Capital Roth Capital analyst Yasmeen Rahimi sees COVID-19 disruptions as only a "minor distraction" from Amarin's continued commercial rollout of Vascepa. Although the pandemic has made it difficult for the company to fully take advantage of its sales expansion started in 2019, Amarin has taken innovative steps to keep interactions between sales reps and doctors, Rahimi tells investors in a research note. Further, the analyst notes that Amarin bumped up the timeline for a Vascepa appeals decision, with a hearing as early as Q3 and ruling thereafter by the end of 2020 or early 2021. With an expedited timeframe for its appeal, Amarin is a "strong buy" ahead of a potential federal circuit ruling, contends Rahimi. Following a deep dive with a "patent law guru," the analyst sees a high probability of success for the company on appeal. Alongside the "strategic optionality" being explored for Vascepa commercialization in Europe and a "strong resiliency" in the COVID crisis, Amarin shares offer "significant upside" potential for 2020, says Rahimi. The analyst keeps a Buy rating on the name with a $31 price target.:D The stock closed Friday at $7.34. Read more at: https://thefly.com/landingPageNews.php?id=3084953
Northland starts Amarin at Outperform amid 'major paradigm shift' 10:13 AMRN Northland analyst Carl Byrnes initiated coverage of Amarin with an Outperform rating and $15 price target. The stock closed Monday up 28c to $7.62. The expanded label given to Vascepa represents a "major paradigm shift" in lipid management, addressing "sizeable" market opportunities in the U.S., Europe and the rest of the world, Byrnes tells investors in a research note. And while the ongoing patent litigation represents a "major risk," potential generic entrants will not be able to procure sufficient quantities of FDA-grade icosapent ethyl to pose a material commercial threat, predicts the analyst. Byrnes anticipates a ruling in the patent appeal in late 2020 or early 2021. The risk/reward profile of Amarin shares is compelling, says the analyst.
Patent attorney finds Amarin appeal brief effective, says H.C. Wainwright With Amarin having filed its opening appeal brief with the U.S. Court of Appeals for the Federal Circuit, H.C. Wainwright analyst Andrew Fein consulted with a patent attorney on initial perspectives. The patent attorney concluded that Amarin has done a thorough job presenting its case and effectively presented its opening shot in the best light possible, Fein tells investors in a research note. The attorney further believed the brief explained the Vascepa technology and the basis of the invention thoroughly, why it was needed and the approach the inventor took to solve the problem of lowering triglycerides in patients with severe hyperlipidemia without raisi ng LDLs, adds the analyst. Fein points out that Amarin essentially has two main lines of argument: that the court erred in finding a prima facie case of obviousness because it did not apply the correct analytical framework and erred in its approach to secondary considerations. Fein's consulted attorney found Amarin's second line of argument compelling, both on the merits and on the clarity and force of argument. That said, the company only needs to be right on one, Fein adds. He keeps a Buy rating on Amarin with a $51 price target
Sensationelle Ergebnisse gestern und der Kurs macht fast Nichts, dank dem krassen Fehlurteil von Richterin Du.....
Amarin Corporation plc (AMRN)EQUITY RESEARCHMay 14, 2020Price: $7.42Price Target: $35.00Rating: OverweightKey Statistics:SymbolNASDAQ: AMRN52-Week Range$3.95 - $26.12Market Cap (M)2,860.3ADV (3 mo)15,538,966Shares Out (M)385.5Research Analysts:Louise Chen212-915-1794Louise.Chen@cantor.comBrandon Folkes, CFA212-294-8081Brandon.Folkes@cantor.comJennifer Kim212-829-4860Jennifer.Kim@cantor.comCarvey Leung212-915-1917Carvey.Leung@cantor.comOne-Year Price History3025201510505/1908/1911/1902/2005/20AMRNCreated by BlueMatrixQuick TakeSteady Stream of Positive Data Supporting VascepaDoesn't Skip a BeatTakeawaysnToday (5/14), AMRN announced data from the REDUCE-IT study presented byBenjamin E. Peterson, M.D., Brigham and Women?s Hospital Heart & VascularCenter and Harvard Medical School, at the Society for Cardiovascular Angiography& Interventions 2020 Scientific Sessions. The study showed that administrationof 4g/day of Vascepa resulted in a significant 34% reduction in first coronaryrevascularizations versus placebo (p<0.0001). Similar reductions of 36% wereobserved in total, or first and subsequent, revascularizations (p<0.0001). These datasupport our OW rating on the stock and our belief that the peak sales potential ofVascepa is still underappreciated. Please see here for the post hoc analyses.nCoronary revascularization procedures are invasive, carry multiple risks, and can havesignificant direct and indirect costs. Patients with elevated triglycerides, despite statintherapy, have increased risk for ischemic events, including coronary revascularizations.These procedures, whether pre-scheduled or performed in an emergency, often resultin additional time spent in a healthcare setting.nThe analyses from the REDUCE-IT study included several types of coronaryrevascularization events in statin-treated patients with persistent elevatedtriglycerides (135-499mg/dL), who also had either cardiovascular disease or diabetesand additional cardiovascular risk factors. Prespecified tertiary endpoint analysesshowed that times to first revascularization events were significantly reduced byVascepa versus placebo across subtypes of intervention, including urgent, emergent,and elective revascularizations, which were reduced by 34% (p<0.0001), 38% (p=0.02),and 32% (p<0.0001), respectively. In post hoc analyses, Vascepa significantly reducedpercutaneous coronary intervention (PCI) by 32% (p<0.0001) and coronary arterybypass grafting (CABG) by 39% relative to placebo (p=0.0005).nREDUCE-IT was not specifically powered to examine individual cardiovascularendpoints; therefore, p-values presented for these revascularization analyses arenominal and exploratory with no adjustment for multiple comparisons. In addition,coronary revascularization as an endpoint can sometimes be considered subjective;however, these endpoints were adjudicated by an independent, blinded clinicalendpoint committee. Results from the total coronary revascularization eventsanalyses are consistent across the various recurrent event statistical models andare also consistent with the first coronary revascularization events results. Together,the REDUCE-IT first and total coronary revascularization events results support therobustness and consistency of the clinical benefit of Vascepa therapy in reducingcoronary revascularization.Investment ThesisWe reaffirm our OW rating and think the peak sales potential of Vascepa isunderappreciated. Therefore, upward earnings revisions to levels not reflected in FactSetconsensus expectations should drive AMRN shares higher.The Disclosure Section may be found on pages 3 - 4. ValuationWe continue to use a blend of DCF and multiples (EV/EBITDA) analysis to get to our 12-month price target of $35.RisksAmarin Corporation is a commercial-stage company, although it is still involved in theclinical pathway to expand the label for its currently approved product. As such, Amarinis subject to certain risks.Regulatory Risk: Actual clinical results and the FDA's conclusions may deviate fromexpectations. Many of our model assumptions are based on incomplete clinical data.Ultimately, it is the regulatory bodies of the Food & Drug Administration (FDA) andEuropean Medicines Agency (EMA) that will determine the approval process of the clinicalfind
Danke für Deine Infos. Das wäre ja ein Traum, wenn sich die Richterin geirrt hat und die Berufung zugunsten von Amarin ausgehen würde ! UND dieses Kursziel wäre natürlich auch ein Traum ! Leider wird sich das Thema wohl noch sehr lange hinziehen ! Ich bin zu 7 Euro mit einer ersten kleinen Position eingestiegen. Überlege aber, hier nochmal nachzulegen.... Kann halt nur nicht die Sachlage und die erste Entscheidung der Richterin richtig einschätzen !?
FDA erteilt Hikma Pharmaceuticals die Zulassung für deren Vascepa® Generikum
Eine Zulassung ist noch keine Produktion, ich glaube Hikma wird die Gerichtsentscheidung erstmal abwarten, bevor sie auch nur einen Dollar in die Hand nehmen werden um die notwendigen Produktionsanlagen zu entwickeln. Die Errichtung würde ca. 6 Monate dauern. Die Berufungsentscheidung wird wahrscheinlich frühstens im Dezember 2020 getroffen.
The trial primary endpoint is the effect of VASCEPA versus usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The clinical study design also includes other endpoints that assess rates and severity of COVID-19 infection in this high-risk group. Based on our current understanding of the biological effects of a COVID-19 infection, including that patients at high risk of cardiovascular disease are at higher risk of mortality and severe effects from a COVID-19 infection, and based on data related to the mechanism of action and effects of VASCEPA in lowering cardiovascular risk in certain high-risk patients, it is believed that VASCEPA could play a beneficial clinical role in helping patients infected by the virus.
The clinical effects of VASCEPA are multi-factorial...
Und zu Hikma, das ist keine Neuigkeit in dem Sinne, sondern Hikma sind einfach die Ersten von weiteren Generika Herstellern, die, wie Hikma, seit 2016 auf der Matte stehen. So sieht Cantor Fitzgerald analyst Louise Chen es ?still positive? on Amarin, DESPITE the FDA approval of the Hikma generic. She said it seemed UNLIKELY that Hikma would begin selling its generic before a decision on the appeal, and thinks AMARIN WILL WIN IT APPEAL. She also noted the Vascepa supply chain is complicated, and said it could be hard for Hikma to manufacture a large amount of the drug."