Correvio Pharma Corp (NASDAQ: CORV) is having an incredibly strong day in the market today, and for good reason. The company said that it intends on refiling a New Drug Application with the FDA. Of course, the news led to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about:
- The NDA resubmission;
- what we’re seeing from CORV stock as a result; and
- what we’ll be watching for ahead.
CORV Heads Up On NDA Resubmission
As mentioned above, Correvio Pharma is having an incredibly strong day in the market today after announcing its intent to refile a New Drug Application (NDA) with the United States Food and Drug Administration (FDA). In a press release issued early this morning, the company said that based on productive pre-NDA discussions with the FDA, it will resubmit the NDA for Brinavess. CORV is expecting to resubmit the NDA in the second quarter of 2019.
In the release, the company reminded investors that Brinavess is an atiarrhythmic drug for the rapid conversion of recent onset arterial fibrillation. The company also said that the FDA has agreed that no additional studies would be required for the resubmission of the NDA. In a statement, William Hunter, MD, CEO and President at CORV, had the following to offer:
These communications, including our recent pre-NDA meeting, represent a significant milestone for Correvio, since we have learned from the FDA that it would be permissible to resubmit the NDA with the clinical and post-marketing surveillance data that we have already collected… We are pleased with the collaborative nature of the FDA discussions that clarified a path forward for resubmission of the Brinavess NDA in Q2 2019, and we look forward to working closely with the FDA during the review process.
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 leads to moves. In the case of Correvio Pharma, the news proved to be incredibly positive. After all, in some cases, when an NDA ends with a CRL, the asset is scrapped. However, it seems as though this asset may make it to market after all. So, it comes as no surprise that excited investors are pushing the stock through the roof in the market today. At the moment (11:05), CORV is trading at $3.80 per share after a gain of $0.68 per share or 21.79% 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 Brinavess and the NDA that will be submitted relatively soon. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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