Amarin Corporation plc (NASDAQ: AMRN) stock surged 12.58% on March 29^th, 2019 (Source: Google finance) but corrected over 4.3% on April 1^st, 2019 (as of 10:27 AM EDT; Source: Google finance). The American Diabetes Association (ADA) issued positive updates surrounding Vascepa following the results of the REDUCE-IT cardiovascular outcomes study. This was approved by the ADA’s Professional Practice Committee. This committee is responsible for producing the annual Standards of Care. The Standards of Care update referenced the active ingredient in Vascepa (icosapent ethyl) capsules. AMRN’s licensee in Canada, HLS Therapeutics Inc., has received formal confirmation from Health Canada that the Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission (“NDS”) for Vascepa (icosapent ethyl) capsules.  HLS Therapeutics anticipates filing the NDS in April 2019 seeking approval to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors. After the landmark results of the REDUCE-IT study in which Vascepa 4 g/day demonstrated a 25% reduction compared to placebo in the first occurrence of major adverse cardiovascular events (MACE) consisting of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization

Vascepa is currently approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Moreover, the company has commenced the transmission of data to the FDA to support the submission of a supplemental New Drug Application (sNDA).The sNDA is seeking an expansion of the Vascepa FDA label based on the REDUCE-IT trial results. The company said that the ADA does not provide endorsements or any form of certification for brand name commercial products as a general policy of the organization. As a result, the inclusion of icosapent ethyl in ADA’s Standards of Care should not be understood as an endorsement or approval by the ADA of Vascepa

Meanwhile, net total revenue for 2019 is expected to increase by more than 50% over 2018 to approximately $350 million, mostly from U.S. sales of Vascepa.  Amarin believes that continued quarterly variability in revenues is likely.

Additionally, excluding non-cash gains or losses for stock-based compensation, the  non-GAAP adjusted net loss was $28.9 million for the fourth quarter of 2018 compared to non-GAAP adjusted net loss of $19.0 million for the fourth quarter of 2017. Net total revenue, the majority of which was recorded prior to REDUCE-IT results, reached a record level of $229.2 million in 2018, including net total revenue of $77.3 million in the fourth quarter of 2018.  The results represent increases of approximately 27% and 44% for full year and fourth quarter of 2018 over the corresponding periods of 2017, respectively, primarily reflecting Vascepa prescription growth.