Amarin Corp. (AMRN:NASDAQ) ADR shares are up sharply today after the company reported record revenues for H1/19 and raised yearly revenue guidance from $350 million to $380-$450 million. The company also advised that it plans to double its U.S. sales force by October 2019 and that its sNDA (supplemental new drug application) PDUFA goal date of September 28, 2019, for expanding indications for its first FDA-approved drug Vascepa, remains on track.
"Amarin submitted an sNDA to the U.S. Food and Drug Administration (FDA) in March 2019 seeking to expand the indication for Vascepa based on the positive results of the landmark REDUCE-IT™ cardiovascular outcomes study. The expanded label is expected to allow for considerably broader promotion of Vascepa in the United States. It was announced in May 2019, the FDA accepted the sNDA for filing and granted Priority Review designation with an assigned PDUFA goal date of September 28, 2019," the company reported.
If the FDA approves the sNDA, the company noted that "Vascepa is anticipated to be the first drug with an indication to reduce residual cardiovascular risk in patients with statin-managed LDL-cholesterol, but persistent elevated triglyceride (TG) levels, an important indicator of cardiovascular disease."
Amarin Corp. develops therapeutics to improve cardiovascular health. "Its product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States," the release noted.
The company's U.S. ADR shares are currently trading at $21.94/share, up $2.70/share (+14.03%) over Monday's close of $19.24. More than 25 million shares have traded through the first three hours of trading, which is more than five times the 50-day average volume of 5.1 million shares/day.[NLINSERT]
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