NEW YORK, NY / ACCESSWIRE / September 25, 2018 / Shares of Amarin Corporation were on fire on Monday after the company reported top line data results on Vascepa, the first Pure EPA prescription Omega-3 clinically proven to lower very high triglyceride,s without raising bad cholesterol (LDL-C). Shares of AcelRx also saw big gains as the market anticipates an FDA meeting next month where it will be reviewing the company’s marketing application for its pain drug Dsuvia.
RDI Initiates Coverage on:
Amarin Corporation plc
AcelRx Pharmaceuticals, Inc.
Amarin Corporation plc shares were skyrocketing on Monday, closing the day up a whopping 314.72% on high volume. The stock soared to a brand new high of $12.47 on a little more than 160 million shares traded. Average trading volume for the stock is a little under 3.5 million shares. The big jump came after Amarin announced that its drug derived from fish oil reduced the risk of heart attacks, strokes and deaths in certain high-risk patients. The top-line results revealed that Vascepa cut the risk of cardiovascular events in its study’s subjects by approximately 25%. The global study had 8,179 statin-treated adults with elevated CV risk. “We are delighted with these topline study results,” said John F. Thero, president and CEO of Amarin. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
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AcelRx Pharmaceuticals, Inc. shares were up 16.46% at the close on Monday with nearly 3.7 million shares traded. There was no news from the company but traders may have been gearing up for a Food & Drug Administration advisory committee meeting that will be reviewing the company's marketing application for Dsuvia. The meeting is scheduled for October 12th. The company is aiming to get Dsuvia approved for the management of moderate to severe pain in settings that have medical supervision. The drug's active ingredient, sufentanil, is already approved for intravenous and epidural administration, but the company has also developed a sublingual tablet which can dissolve under the patient's tongue. Last year the FDA had sent a response letter to the company asking for more data from patients who were treated with the maximum dose. It also wanted some changes in the instructions that go with the drug. With yesterday's jump, Wall Street may be optimistic that the application will be approved next month.
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