24.01 -0.01 (-0.04%)
After hours: 6:35PM EST
|Bid||24.06 x 3100|
|Ask||24.01 x 1200|
|Day's Range||22.28 - 24.67|
|52 Week Range||11.78 - 24.67|
|Beta (3Y Monthly)||1.14|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 5, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||29.44|
Amarin stock topped a buy point Friday after a Food and Drug Administration advisory committee unanimously supported a second use for the biotech company's key drug, Vascepa.
Amarin Corporation (NASDAQ: AMRN) traded higher after the FDA's Endocrinologic and Metabolic Drug Advisory Committee voted 16-0 to recommend approval of label expansion for Vascepa capsules to include reduction in the risk of cardiovascular, or CV, events in high-risk patients. Vascepa was initially approved in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The Adcom reviewed the drug based on the results from the Phase 3 REDUCE-IT CV outcomes trial, which showed that the addition of Vascepa to statin therapy brought down the risk of cardiovascular events by 25% compared to statins along with mineral oil, which was used as placebo.
The Dow Jones today is rising on China trade hopes. Apple stock got a price target hike. Applied Materials, RH, JD.com, Amarin are moving near buy points.
(Bloomberg) -- The unanimous panel backing to expand the label for Amarin Corp.’s heart drug Vascepa sparked debate across Wall Street as analysts and investors weighed whether the drug could be sold to as many as 15 million Americans.The divide comes after members of an advisory panel to the U.S. Food and Drug Administration “offered different opinions when it came to specific recommendations for a potential Vascepa label,” according to analysts at Roth Capital Partners. That may leave billions in sales hanging in the balance. But Jefferies’ Michael Yee disagreed, saying the “label debate doesn’t really matter to the thesis” for investors. He believes doctors will use the drug “widely across patients.”Amarin shares climbed as much as 11% Friday after being halted all day Thursday. With the stock briefly nearing $24 a share, it traded about a nickel short of a July peak.Here’s what analysts had to say about the news.Roth Capital Partners, Yasmeen Rahimi“With unanimously favorable response for label expansion, question moves to which patients make it on label, with 10/16 docs voting in favor of both” atherosclerotic cardiovascular disease groups. Roth highlighted that some committee members “were caught up with analysis that showed a 12% relative CV risk reduction” without significant benefit for patients who had not had something like a heart attack or stroke and are at a lower risk.Counted 10 of the 16 panelists “who were receptive to Vascepa label expansion including primary and secondary prevention patients” with the six others wanting the drug’s label to include patients who have had a stroke, or have cardiovascular disease.Says there was “lots of safety talk, but vote indicated AdCom members felt the two signals could be adequately managed through label, thus meaning no patient restrictions.”Maintains buy rating with $31 price target.Jefferies, Michael Yee“Our thesis and valuation are not based on specific ‘details’ of a label as we think docs will use this widely across patients...if stock was down, we think it bounces since label details don’t matter in big picture.”Notes that while Amarin got the positive vote for approval, “investors will debate whether the labeled indication will include a more broad ‘primary prevention’ (high-risk) population which is patients w/o established CV disease but have diabetes and at least one other major” cardiovascular risk factor.Highlights that the “stock has already run-up a lot and we wouldn’t be surprised if it’s volatile on this labeling discussion but we aren’t changing numbers as the populations are huge already.”Maintains buy rating, $30 price target.Cantor Fitzgerald, Louise Chen“There were few-to-no surprises brought up during the meeting, in our view, and we think Vascepa is well on-track now for expected approval by year-end.”Notes that most of the meeting “focused on concerns about the impact of mineral oil, as well as on which patient populations should be included in the label. Although some AdCom members believe mineral oil may have affected results somewhat, they agreed that the REDUCE-IT data are meaningful enough to warrant approval.”Highlighted that panelist discussions on how high patients’ triglycerides, a type of fat in the blood, must be to benefit were “less clear-cut compared to the mineral oil debate.”Maintains overweight rating with a $35 price target.Citi, Joel BeattyAmarin is unlikely to reach a market value above $10 billion over the next several months with its market value at $7.7 billion as of Wednesday’s close.Sees the drug as “likely to be used in high-risk primary prevention patients regardless of” the exact label wording, though there will likely be some debate over the coming weeks regarding the label.“We believe the exact wording of the indication matters relatively little compared to other drugs, because we believe physicians will still use Vascepa in very high risk” primary prevention patients.Maintains buy rating and $23 price target.Stifel, Derek Archila“While the panel was in agreement Vascepa should be approved for secondary prevention patients (our base case), the key question that remains is whether or not Vascepa will receive a broader label inclusive of primary prevention patients, which would be upside to our model.”“We believe approval in secondary prevention alone offers an addressable market that is at least ~10-15 million patients for Vascepa, making us comfortable with our ~$3 billion in peak sales estimate.”Rates shares at buy with a $26 price target.(Updates share movement in third paragraph.)To contact the reporter on this story: Bailey Lipschultz in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Catherine Larkin at email@example.com, Scott Schnipper, Richard RichtmyerFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
(Bloomberg Opinion) -- Drugmaker Amarin Corp Plc shocked the world last year when a long-running clinical trial showed that its medicine derived from purified fish oil, Vascepa, substantially reduced the risk of cardiovascular events like heart attacks in high-risk patients. After the euphoria and 300% stock rally off the news faded, the question remained precisely how big a blockbuster it might be. Part of that question was answered Thursday after a panel of experts convened by the Food and Drug Administration reviewed Amarin's data. They voted 16 to 0 that Vascepa was safe and cuts cardiovascular events. The vote doesn’t bind the FDA, but the agency often follows panel recommendations, so it would be a surprise now if the drug isn’t made available to more Americans. That’s big news for Amarin — and for many patients. We still don't know exactly how good the news is, however, and won’t until the FDA makes a final decision by the end of the year. There was consensus on the drug’s overall effectiveness. Still, the panelists disagreed about how far that impact extends. Access for millions of additional patients and billions of potential sales are still up the air, which means there’s more volatility ahead for Amarin investors. The market seems focused on the positives for now: Amarin shares surged 7% in early trading Friday after rising more than 20% on Tuesday, when the FDA released briefing documents ahead of the panel that were seen as relatively supportive for the drug.Vascepa is already available for a small group of people with very high triglycerides, a blood fat that the drug targets. NowAmarin is understandably looking to leverage its dramatic success into the biggest possible new commercial opportunity. But while Vascepa’s benefit looks clear in patients that have already had a cardiac event — hence the unanimous vote — some panelists weren’t as convinced on its impact on lower-risk patients, the largest potential market for the drug. In their view, because the benefits aren’t as strong in that group, questions about the drug’s impact and safety should carry more weight and limit the scope of approval. Those concerns included the use of mineral oil in the placebo arm of the trial, which may have mildly impacted trial results, as well as a potentially elevated risk of bleeding and atrial fibrillation. The number of potential nuances in the drug’s expanded approval and the size of the population in question mean that the specifics of the agency’s decision will still be a huge swing factor for Amarin. The FDA’s choices will go a long way towards determining Vascepa’s upside, growth trajectory, and whether an expensive additional trial may crimp Amarin’s profitability.The skeptics weren’t the only voices in the room. A number of panelists focused instead on the overall positive impact shown in the trial and were more comfortable with a broader prescribing guidelines. Advocates who spoke during the public portion of the meeting, as well as at least one panelist, noted that a restrictive approval would likely lead insurers to more strictly curb the use of a medicine that could benefit many people.The FDA holds these panels for a reason and will consider the concerns raised on Thursday. But it will also look at the risks of being too cautious, given the enormous economic and personal burden created by cardiovascular disease. After all, it isn’t often that we see a medicine that can impact America’s biggest cause of death in a cost-effective way.To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Beth Williams at email@example.comThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
Amarin (AMRN) gets favorable FDA Advisory Committee vote to expand the label of Vascepa capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides.
An advisory panel voted to recommend that the Food and Drug Administration allow doctors to prescribe Vascepa to prevent heart attacks and strokes.
Shares of Amarin Corp. are up about 6% in premarket trading after a U.S. Food and Drug Administration advisory committee on Thursday voted 16-0 in favor of a broader label for the company's prescription fish oil-derived pill. The FDA is expected to decide on the new label by Dec. 28. If approved, Vascepa would be marketed as a treatment to lower the risk of cardiovascular events, like heart attacks or strokes. This label expansion would also likely expand the size of the patient population from 4 million to more than 40 million, according to Maxim Group analyst Jason McCarthy. "In our view, the market has the potential to be statin-like in size," he wrote in a note Friday. Stifel estimates $3 billion peak sales of Vascepa. Shares of Matinas BioPharma Holdings , which is developing a similar drug to Vascepa, also rose in premarket market trading, up 14%. Amarin stock has jumped 57.9% year-to-date, while the S&P 500 is up 23%.
Futures rose on China trade news. RH leapt on Warren Buffett taking a position. Nvidia and Applied Materials were active on earnings. An FDA panel backed an Amarin drug. Apple ticked up.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Nov. 14) 10X Genomics Inc (NASDAQ: TXG )(IPOed Sept. 12) 89bio ...
TORONTO , Nov. 15, 2019 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (HLS.TO), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that the Endocrinologic and Metabolic Drugs Advisory Committee ("EMDAC") of the U.S. Food and Drug Administration ("FDA") yesterday voted unanimously (16-0) that Amarin Corporation plc (AMRN) provided sufficient evidence of efficacy and safety to support the approval of Vascepa® (icosapent ethyl) capsules for an indication and label expansion to reduce the risk of cardiovascular events in high risk patients based on results from the landmark REDUCE-IT™ cardiovascular outcomes trial. HLS has in-licensed the exclusive rights to Vascepa for the Canadian market and has filed a New Drug Submission for Vascepa with Health Canada.
Amarin Corporation plc (AMRN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa® (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the landmark REDUCE-IT®1 cardiovascular outcomes trial. The FDA is not bound by the recommendations of an advisory committee.
A Food and Drug Administration advisory committee voted unanimously Thursday in support of approving a second use for biotech company Amarin's high triglyceride treatment, Vascepa.
An advisory committee of the Food and Drug Administration voted unanimously to recommend approval of the fish-derived drug Vascepa to reduce the risk of cardiovascular events like heart attack and stroke.
(Bloomberg) -- Amarin Corp. shares may extend their recent gains after an advisory panel to the U.S. Food and Drug Administration voted unanimously in favor of expanding the label for its heart drug Vascepa.All 16 panelists voted that the drug should be sold as a medicine to reduce the risk of cardiovascular events like stroke and heart attack, agreeing that the drug was both safe and effective. The approval could open up the potential patient population to 10 million from 600,000 currently, SVB Leerink estimated in a note earlier this month.A key debate for panelists was to what extent the label should broadened, and whether patients who have not had a stroke, or have cardiovascular disease, benefit. The conversation also centered on how high patients’ triglycerides, a type of fat in the blood, must be to benefit.“There are some uncertainties here and there with these data but most of them relate to their primary prevention cohort,” panelist Susan Ellenberg said in reference to patients who had not had something like a heart attack or stroke and are at a lower risk. “My feeling is that I may tend to leave it to clinical judgment about who should get” the drug.Panelist James de Lemos was more skeptical, saying Vascepa “should be approved for secondary prevention only,” with the company needing to study Vascepa against a placebo in those lower risk patients. Jefferies analyst Michael Yee wrote earlier Thursday that the potential patient population could reach five to 15 million in the U.S., though only having one million patients on the drug would still make it a $2.5 billion medicine.The recommendation clears a big hurdle for what could result in more than $1.5 billion in annual sales, according to Wall Street analysts, and may set up Amarin for an outright sale to a larger drugmaker looking to bolster its portfolio of heart drugs. Vascepa, which is currently sold in a more niche population of adults with severely high levels of triglycerides, could bring in more than $4 billion a year in peak sales, depending on the drug’s label, SVB Leerink estimated.“My inclination is to let something go onto the market that does have demonstrated benefit,” panelist Anna McCollister-Slipp said in the group’s discussion period.While the panel agreed that Vascepa’s label should be expanded, the ultimate decision of how large the potential patient population will be lies in the FDA’s hands. The wording of the panel voting question leaves the potential population to the agency’s discretion.U.S. regulators are expected to make a final decision by Dec. 28, and while the agency typically heeds the advice of its panels of experts, it isn’t obligated to. Shares of the drugmaker were halted Thursday during the panel, but ended Wednesday trading at a four-month high.The label’s wording will likely be another debate between bulls and bears, but Jefferies’ Yee sees the potential wording as having a more muted impact to consensus sales estimates. “We think it’s a good debate to have around wording of the label, but will not dramatically impact the stock either way or consensus numbers,” he wrote in the mid-day note.The stock on Tuesday had its best session since game-changing data back in September 2018 after agency documents were seen as “generally positive” across Wall Street. Analysts told Bloomberg in an Oct. poll that shares could move more than 20% depending on the panel’s outcome and agency documents.Short-sellers had been piling in ahead of the meeting with about $1.2 billion of shares available for trading sold short, data compiled by financial analytics firm S3 Partners showed. That’s the highest level in at least a year and more than five times the number of shares shorted in mid-December.Micro-cap peers that are studying similar medicines surged in late trading. Acasti Pharma Inc. jumped more than 20% while Matinas BioPharma Holdings Inc. climbed 11%.\--With assistance from Michelle Fay Cortez.To contact the reporter on this story: Bailey Lipschultz in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Catherine Larkin at email@example.com, Cristin Flanagan, Scott SchnipperFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc's fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease. The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for Amarin which has only one drug, Vascepa, in the market. Vascepa, a highly purified form of omega-3 fatty acid, won U.S. approval in 2012 to lower high levels of triglycerides.
Amarin Corporation plc (NASDAQ: AMRN) shares were halted for trading Thursday morning pending an announcement of the Adcom verdict on the label expansion it is seeking for its fish oil pill Vascepa. Amarin shares have been on a tear this week, with the stock gaining about 24% Tuesday in reaction to the briefing document released ahead of the FDA panel decision. Incidentally, the stock lost roughly 17% Aug. 9 in reaction to the company's disclosure of an FDA communication regarding the convening of the Adcom meeting. What's An Adcom Meeting?
Advanced Micro Devices Inc. (AMD) jumped 81 cents to $37.52 on 67 million shares traded Wednesday. Amarin Corp. PLC (AMRN) followed through on Wednesday, up 55 cents to $21.49 after popping 23% on Tuesday. An FDA advisory committee is scheduled to meet today to help decide the fate of the company’s fish-derived cardiovascular drug.
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The meeting is meant to decide whether doctors can prescribe Vascepa, a fish-derived drug now used to reduce triglycerides, to prevent cardiovascular events like heart attacks and strokes.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs Nov. 13.) Antares Pharma Inc (NASDAQ: ATRS ) Arrowhead Pharmaceuticals ...
Shares of Amarin Corp.have gained 23% on the week on expectations that a U.S. Food and Drug Administration advisory committee will recommend that the regulator grant a broader indication for the company’s prescription fish oil-derived pill.
Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that NASDAQ has halted trading of the company's shares. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), as previously scheduled and announced, is meeting today to openly discuss the company's supplemental New Drug Application (sNDA) seeking a new indication for Vascepa® (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on the landmark REDUCE-IT® cardiovascular outcomes study.
Amarin hopes to market the medication, Vascepa, as reducing the risk of cardiovascular events, such as heart attack and stroke.