Categories Health Care

Where is Amarin (AMRN) headed after FDA panel favors Vascepa’s label expansion?

Biotech firm Amarin Corporation (NASDAQ: AMRN) had a positive start to the week, with the shares making sharp gains and hitting the highest level in more than a decade. Though initially there was speculation as to where the stock is headed, the rally gathered momentum towards the end of the week after an FDA committee unanimously voted in favor of label expansion for Vascepa, the company’s flagship medication made from fish-oil. The stock traded up 14% on Friday afternoon.

Also read: Amarin’s Q3 results top estimates

The market has been abuzz with debates on the efficacy of Vascepa in treating cardiovascular diseases in high-risk patients, as an additional indication. Though experts are divided in their opinion on expanding the label for Vascepa, it is believed that the FDA panel‘s favorable stance has cleared the decks for the drug to reach millions of cardiac patients. The majority of the panel members recommend that the label be expended for atherosclerotic cardiovascular disease groups.

Performance of Amarin's (AMRN) Vascepa in the U.S

It’s been more than a year since Amarin came up with the path-breaking finding, pursuant to an extensive clinical trial, that Vascepa is effective in reducing conditions like stroke and heart attack, without compromising on patient safety. Then, the market responded positively and the stock made sharp gains. Though the FDA needs to take all the related factors into consideration before approving the label expansion, it will give due importance to the committee’s recommendation.

In the meantime, the bullish sentiment surrounding the latest event is expected to fuel the stock’s rally, extending it into the coming weeks. Experts believe that several millions of new patients in America will be using Vascepa following the label expansion, though there is no clarity yet on the drug’s target market.

Related: Amarin Q3 2019 Earnings Conference Call Transcript

Once approved, Vascepa will be prescribed to cardiovascular patients with a high risk of heart attack and currently receiving other forms of therapy. Some analysts are of the view that Amarin might find it difficult to serve the potential market, considering its huge size, which might prompt the management to pursue co-promotion deals with other pharmaceutical companies.

We’re on Apple News! Follow us to receive the latest stock market, earnings and financial news at your fingertips

Most Popular

AVGO Earnings: All you need to know about Broadcom Q1 2021 earnings results

Broadcom Limited (NASDAQ: AVGO) reported first quarter 2021 earnings results today. Total revenue increased 14% year-over-year to $6.65 billion. GAAP net income was $1.3 billion, or $3.05 per share, compared

Infographic: Costco (COST) Q2 2021 sales up 15%; earnings miss

Retail giant Costco Wholesale Corporation (NASDAQ: COST) reported higher earnings and revenues for the second quarter of 2021. Earnings missed analysts’ expectations, while sales beat. Net profit was $951 million

Will shifting to as-a-service model help Hewlett Packard in emerging stronger from COVID?

With the corporate world rapidly shifting to cloud-native computing after the virus outbreak changed work culture and the way businesses operate, technology providers are aggressively innovating their offerings. Hewlett Packard

Add Comment
Viewing Highlight