IntelliPharmaCeutics Intl Inc (NASDAQ: IPCI) is headed for the top in the market this morning, and for good reason. In an SEC filing, the company announced the resubmission of a New Drug Application with the United States Food and Drug Administration.
As you could imagine, the news proved to be a source of excitement for investors who are pushing the stock up. Today, we’ll talk about:
- The NDA resubmission;
- what we’re seeing from IPCI stock as a result; and
- what we’ll be watching for ahead.
IPCI Gains On NDA Resubmission
As mentioned above, IntelliPharmaCeutics is having a great day in the market today after the company announced that it has resubmitted a New Drug Application. The news came by way of an SEC filing (one that suggests that a press release is coming).
In the filing, the company said that it has resubmitted its New Drug Application (NDA) for Oxycodone ER to the United States Food and Drug Administration (FDA).
The treatment has been submitted to the FDA in the past. In fact, the original NDA submitted by IPCI surrounding the drug was submitted in February of 2017. However, the company received a Complete Response Letter from the FDA, requesting more information and offering up recommendations.
As always, it’s important to keep in mind that, as the company said in the filing, there can be no assurance that IPCI will recieve FDA approval and will not be required to conduct further studies. However, considering that this submission is the result of a CRL, it is likely that the company has addressed the concerns of the FDA. Nonetheless, we’ll have to wait for an official statement by the FDA to see if that is indeed the case.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. When it comes to IntelliPharmaCeutics, the news proved to be overwhelmingly positive. After all, the company’s resubmission of its NDA means that it is one step closer to potential approval of its Oxycodone ER product candidate.
As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:47), IPCI is trading at $0.31 per share after a gain of $0.035 per share or 12.69% 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 IPCI. In particular, we’re interested in following the story surrounding the company’s Oxycodone ER resubmission. Should all go well, the treatment could prove to be a strong revenue generator for the company. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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