Correvio Pharma Corp (NASDAQ: CORV) is having an incredibly strong start to the trading session this morning after the company announced a regulatory update surrounding BRINAVESS®. Of course, the update was positive, leading to excitement among investors and sending the stock on a run for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from CORV as a result; and
- what we’ll be watching for with regard to the stock ahead.
CORV Heads Up On Regulatory Update
As mentioned above, Correvio Pharma is having a strong start to the trading session this morning after announcing a regulatory update. In a press release issued early this morning, the company announced that it has received a response from the United States Food and Drug Administration (FDA) with regard to the regulatory path in the united states for BRINAVESS®. BRINAVESS® is an antiarrhythmic drug designed for rapid conversion of recent onset artrial fibrillation. In the announcement, CORV said that the FDA informed the company that it would be permissible to resubmit the BRINAVESS® New Drug Application (NDA). The FDA has also agreed that the company may schedule a Pre-NDA meeting, which is expected to take place in the fourth quarter. In a statement, William Hunter, MD, CEO and President at CORV, had the following to offer:
In our most recent communication with the FDA, we asked the Agency if the Division of Cardiovascular and Renal Products would be willing to meet to discuss a regulatory path forward for Brinavess… We are pleased that the Agency has agreed to discuss Brinavess in a pre-NDA meeting, which we will seek to have in the fourth quarter.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Correvio Pharma, the news proved to be overwhelmmingly positive. With the NDA resubmission taking place soon, there is a catalystic event just around the corner. So, it’s no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:23), CORV is trading at $2.85 per share after a gain of $0.77 per share or 37.02% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on CORV. In particular, we’re interested in following the story surrounding the company’s resubmission of the NDA for BRINAVESS®. If all goes well, the stock could fly ahead. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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