Amarin Corporation plc (NASDAQ:AMRN)

"We are very pleased with the FDA's acceptance for filing of our AMR101 NDA submission as it is a significant achievement in the development of what we believe is a next generation Omega-3 based triglyceride lowering therapy," stated Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin.

AMRN, previously reportedthat its New Drug Application (NDA) for AMR101 has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA reflects the FDA’s determination that the application is sufficiently complete to permit a substantive review.

AMRN is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>=500 mg/dL]), as reported in November 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>=200 and