Amarin Stock Price, News & Analysis

Amarin Corporation has received EC approval for its drug VAZKEPA (icosapent ethyl) aimed at reducing cardiovascular risk in high-risk, statin-treated patients in Europe. This milestone follows FDA approval in December 2019. The approval is based on data from the REDUCE-IT study, involving over 8,000 patients, showing a 25% relative risk reduction in major adverse cardiovascular events. VAZKEPA will benefit from ten years of market protection in the EU, with potential patent extensions into 2039, positioning Amarin strongly for its European launch.

Amarin Corporation plc (NASDAQ: AMRN) announced that icosapent ethyl has been included in the 2021 Canadian Cardiovascular Society (CCS) Guidelines and the Egyptian Heart Journal’s Practical Guidance for lipid management. This recognition signifies growing global support for icosapent ethyl as a treatment option in reducing cardiovascular risk, increasing the total number of endorsing organizations to 15. The CCS recommends its use for patients with atherosclerotic cardiovascular disease and elevated triglyceride levels, highlighting its clinical benefits validated by the REDUCE-IT study.

Amarin Corporation (NASDAQ:AMRN) presented significant findings from its REDUCE-IT STROKE study at the International Stroke Conference 2021. The study demonstrated a 28% reduction in first strokes and a 32% reduction in total strokes with VASCEPA compared to placebo. Notably, ischemic strokes saw a 36% decrease without increasing the risk of hemorrhagic strokes among statin-treated patients with elevated cardiovascular risk. The study won the Paul Dudley White International Scholar Award, highlighting its impactful results for stroke prevention.

Amarin Corporation (NASDAQ:AMRN) reported record annual revenue of $614.1 million for 2020, up 43% from 2019, with Q4 revenue at $167.3 million, a 17% increase year-over-year. This growth was driven by increased use of VASCEPA® (icosapent ethyl) despite COVID-19 challenges. Amarin received a positive CHMP opinion for VAZKEPA® in Europe, expecting formal approval in April 2021. The company ended 2020 with a strong balance sheet, totaling $563.4 million in cash and no debt. Amarin anticipates robust growth in 2021, particularly in the U.S. and international markets.

Amarin Corporation plc (NASDAQ:AMRN) has announced presentations by CEO John F. Thero at two investor conferences: the 10th Annual SVB Leerink Global Healthcare Conference on February 26, 2021, at 9:20 a.m. ET, and the Cowen 41st Annual Health Care Conference on March 1, 2021, at 10:20 a.m. ET. Live audio webcasts will be available on Amarin's website for 30 days post-event. Amarin is committed to evolving cardiovascular disease management and has grown significantly since its inception in 2009, now employing approximately 1,000 individuals globally.

Amarin Corporation announces a conference call for discussing its fourth quarter and full year 2020 financial results on February 25, 2021, at 7:30 a.m. ET. This follows the anticipated release of financial results earlier that day. Investors can access the call via the company's website or by dialing the designated phone numbers. A replay will be available for two weeks thereafter. Questions can be submitted prior to the call via email, and management will respond to queries during the live session.

Amarin Corporation plc (NASDAQ:AMRN) announced that its partner Edding has initiated regulatory reviews for VASCEPA® (icosapent ethyl) in Mainland China and Hong Kong. The Chinese National Medical Products Administration has accepted VASCEPA's new drug application, with a decision expected by the end of 2021. Concurrently, Hong Kong's Department of Health is reviewing VASCEPA based on prior approvals in the U.S. and Canada. Both parties aim to provide this treatment option, highlighting its significance in combating cardiovascular disease in the region.

Amarin Corporation (NASDAQ:AMRN) announced a positive opinion from the CHMP of the EMA recommending marketing authorization for icosapent ethyl, branded as VAZKEPA, for reducing cardiovascular event risks in high-risk patients. This decision is based on over a decade of research, including the REDUCE-IT study, which showed a 25% relative risk reduction in major cardiovascular events among patients taking the drug. A European Commission decision is expected within 67 days, potentially granting ten years of market protection in the EU and extending exclusivity into 2039 through pending patents.

Amarin Corporation has expanded its patent infringement lawsuit against Hikma Pharmaceuticals to include Health Net, a health insurance provider, in the U.S. District Court in Delaware. The lawsuit claims Health Net has induced pharmacies to dispense Hikma's generic icosapent ethyl capsules, infringing on Amarin's patents for cardiovascular risk reduction. Amarin seeks a permanent injunction against these practices and monetary damages. The company emphasizes the significance of its patents in preventative cardiovascular care and plans to pursue the case vigorously, leveraging proceeds from VASCEPA sales.