Plus   Neg

Amarin's Vascepa Gets FDA Approval For Expanded Use, Shares Up 5%

Shares of Amarin Corp. (AMRN) jumped 5% on extended trading session after the company said it received approval to market its drug Vascepa for cardiovascular problems.

Amarin said the U.S. Food and Drug Administration has approved a new indication and label expansion for Vascepa capsules. It is now the first and only drug approved by the FDA "as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease."

"We at Amarin are excited and gratified to now have the opportunity to introduce Vascepa as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies," said CEO John Thero.

"We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin."

Amarin reaffirmed its intention to promptly launch Vascepa in the United States for this important new preventative care indication.

AMRN closed Friday's trading at $24.12, up $1.13 or 4.92%, on the Nasdaq. The stock further gained $1.58 or 6.55% in the after-hours trade.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Pfizer said Friday it reached a multi-year deal with Gilead Sciences to manufacture and supply Gilead's investigational antiviral remdesivir for COVID-19 patients. Ferring Pharmaceuticals US is recalling various nasal sprays citing superpotency or amounts of desmopressin higher than specified, the U.S. Food and Drug Administration announced in a statement. The recall involves all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL. U.S. President Donald Trump has issued executive orders to ban Chinese mobile application TikTok as well as WeChat, citing a threat to national security and its economy. China's ByteDance Ltd. owns TikTok, a video-sharing mobile app, while Tencent Holdings Ltd. owns WeChat, a messaging, social media, and electronic payment app.
Follow RTT