CorMedix Inc. (NYSEAMERICAN: CRMD) is having an incredibly rough day in the market today, and for good reason. The company updated investors with regard to a meeting that took place with the FDA. Unfortunately, the meeting didn’t go quite as investors hoped. Nonetheless, these declines may represent an opportunity at a discount. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from CRMD stock as a result;
- why the declines may represent an opportunity at a discount; and
- what we’ll be watching for ahead.
CRMD Announces Regulatory Update
As mentioned above, CorMedix is having a tough break in the trading session this morning after announcing a regulatory update. In a press release, the company announced of a meeting with the FDA.
The company said that it had begun discussions with the regulatory authority regarding its completed and unblinded Phase 3 LOCK-IT-100 study. The goal of the study is, of course, to support the regulatory approval of Neutrolin.
In the release, CRMD said that the FDA has agreed that it may seek approval of the drug under the LPAD, or Limited Population Pathway for Antibacterial and Antifungal Drugs) pathway. However, this is where things got upsetting.
The hope was that the drug would start the NDA process relatively soon, based on the successful meeting of the Primary Endpoint early in the trial. However, the company said that it has agreed to provide the FDA a detailed analysis of the full data set including secondary endpoints to facilitate the request to file an NDA. Unfortunately, this analysis will take months to complete, further extending the period of time from now until approval.
In a statement, Khoso Baluch, President and CEO at CRMD, had the following to offer:
We believe our meeting with the FDA was very productive and we look forward to continuing discussions with them on whether LOCK-IT-100 is adequate to support the NDA submission. We understand FDA’s desire to assess the full data set. We will continue to pursue our goal of filing the NDA based on the single study, and appreciate the guidance received from the FDA.
Why These Declines Likely Represent An Opportunity
While the fact that the NDA is being pushed back a few months may be disheartening, the truth of the matter is that today’s declines likely represent a strong opportunity at a discounted rate.
At the end of the day, the Phase 3 LOCK-IT-100 trial was overwhelmingly positive. In fact, the trial was ended early because it met its primary endpoint early on. Further analysis only confirmed the efficacy and safety of Neutrolin as an option to avoid catheter-related infections, a real concern among hemodialysis patients.
There’s no surprise in the fact that the FDA wants all of the data it can get its hands on. So, a delay with a request for a completed analysis that’s already underway isn’t really much of a concern.
While the setback may upset some investors, these investors are likely to be more upset down the line when the NDA is submitted following the complete data analysis as they will have likely missed an opportunity. All in all, I believe that the CRMD declines only represent a discounted opportunity to get in on long-run gains.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to invest is that the news moves the market. When it comes to CorMedix, the news proved to be negative as investors will have to wait a few more months to see a positive NDA-related update. So, it’s not surprising to see that the stock is falling in the market today. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:06), CRMD is trading at $1.95 per share after a loss of $0.52 per share or 21.05% 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 CRMD. In particular, we’re interested in following the story surrounding the company’s continued work to bring Neutrolin to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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