Amarin up 24% due to clinical results

Today 11/12/18, Amarin share price rocketed up 23.8% in response to the company’s release yesterday of the following highly positive significant results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)” that on 11/14/18 will be presented to the U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee:

• Prespecified analysis of 3,146 patients in the USA enrolled in REDUCE-IT showed 31% relative risk reductions for first occurrence of both 5-point MACE and 3-point MACE.

• Significant reductions shown in all predefined composite and individual cardiovascular endpoints, including cardiovascular death and all-cause mortality.

• Tolerability and safety findings consistent with full study.

• Icosapent ethyl was a dominant strategy (i.e., cost saving) in 70% of simulations, offering the rare finding of better outcomes at lower healthcare costs. In probabilistic sensitivity analysis, >85% of simulations indicated that icosapent ethyl would be cost-effective (i.e., below $50,000 per QALY gained) compared with placebo.

The clinical study concluded:
In this combined patient-level and simulation cost-effectiveness analysis, icosapent ethyl in high CV risk patients shows exceptional benefit with CV event reduction as well as cost-savings in-trial and over patients’ lifetime in the majority of simulations.

John Thero, president and chief executive officer of Amarin, developer of Vascepa, commented, “This analysis helps to validate something we’ve long believed, and that is central to our mission. It is possible to deliver significant innovation that meaningfully addresses our nation’s most prevalent and costly health epidemic, reduces impacts on patients and families, and drives down costs longer term in the health system. We are working to make this therapy broadly available for improved patient care in high risk patients subject to appropriate regulatory review.”

Amarin is seeking to expand the label to say that Vascepa can reduce cardiovascular risks, like stroke, heart attack or death. A label expansion would significantly grow the size of potential patient population for the drug. Amarin president and CEO John Thero told investors during an earnings call last week that “millions of patients” may be helped by “the potential to use Vascepa and its cardio protective results.”

Amarin share price jumped 23.8% today on the likelihood 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. While the FDA is not required to follow the guidance of its advisory committee, the regulator usually does. The FDA is expected to make its final decision on Vascepa by December 28, 2019.

Y-T-D, Amarin share price is now up 53.8%, closing at $20.94/share today, 11/12/19:



Yes! I bought calls last week so that was very nice! Sold half or so of them today and I’m letting the rest ride until Thursday.
Official FDA label expansion Mtg is actually Thursday but today investors must have paid for information that suggests strongly in favor of expansion.
Great news for the company and I’m excited to be along for the ride.
I bought about 65 shares as well before/after earnings

On cursory first glance:

-this is a subgroup analysis, which I typically do not like AND
-they also include composite end points, which usually means the drug doesnt work well if at all.


-the 2.6% all cause mortality benefit is interesting and probably going to be a big selling point.

I’m always scared of stocks that go from penny stock to 7-10x almost overnight like Amarin (what actually happened there about a year ago anyway?), but the mortality benefit is likely going to be hard to ignore. Its 7.5b now and I’d have to look over their prior data, but probably could still grow from here. Multiple biotechs have continued to grow after positive P3 data, even when they look overvalued. If they get label expansion, which it looks like theyre gunning for, this could be a blockbuster; as a one-trick pony without a pipeline, I assume they’ll get bought out in the next year or two.

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ADCOM committee voted 16 - 0 in favor of label expansion. This should have a great day today (11/15/2019). Other stocks that are on this same theme will be MTNB and ACST.