IntelliPharmaCeutics International Inc (NASDAQ: IPCI) is having an incredibly strong start to the trading session this morning, making up for the declines seen on the stock yesterday. After a NASDAQ notice of non-compliance hit the stock hard yesterday, the company announced an FDA approval this morning. Of course, the news of the approval excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from IPCI as a result; and
- what we’ll be watching for with regard to the stock ahead.
IPCI Announces FDA Approval
As mentioned above, IntelliPharmaCeutics International is having a great day in the market today after announcing an FDA approval. In a press release issued early this morning, the comapny said that it has received final approval from the FDA for its abbreviated new drug application.
IPCI said that the application that was approved was for venlafaxine hydrochloride extended-release capsules. The strengths approved were 37.5, 75, and 150 mg. The approved product is a generic equivalent to the branded Effexor XR, which is sold in the United States by Wyeth Pharmaceuticals.
The treatment, indicated for major depressive disorder generated $470 million in sales across name brand and generic sales in the 12 months ending in October. In a statement, Dr. Isa Odidi, CEO at IPCI, had the following to offer:
We believe that the approval of our application for a generic version of Effexor® XR is a validation of the scope of our drug delivery technologies and formulation capabilities, and that it also demonstrates our regulatory capabilities and commitment to obtaining regulatory approvals for our pipeline of product candidates still awaiting FDA approval. We are actively exploring the best approach to maximize our commercial returns from this new approval.
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 IntelliPharmaCeutics, the news proved to be positive. After all, the approval will likely lead to revenue growth, and investors love to see growth. It’s also possible that this approval will lead to an extension for the company to regain compliance with the NASDAQ once they have the meeting with the panel, an extension that was far out of reach when the notification from the NASDAQ was announced yesterday. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:04), IPCI is trading at $0.40 per share after a gain of $0.06 per share or 17.58% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on IPCI. In particular, there are two factors that we’re watching. First and foremost, we’re following the story with regard to the notice that was announced yesterday surrounding NASDAQ noncompliance. We’re also interested in following the sales of the treatment that was approved today and whether or not the treatment leads to an unexpected extension from the NASDAQ. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the iWatch Markets mailing list below!