CorMedix Inc. (NYSEAMERICAN: CRMD) is up more than 10% this morning after announcing that it would be ringing the closing bell at the New York Stock Exchange. However, the bell announcement served as a reminder of coming catalysts. Here’s what’s happening:
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CRMD Announces Bell Ringing Event
In a press release issued early this morning, CorMedix said that it will be ringing the closing bell at the NYSE this afternoon at 4:00 p.m. ET. As is always the case, the event can be viewed live on the NYSE’s website, www.nyse.com.
While the simple fact that CRMD will be ringing the closing bell is exciting, the announcement also served as a reminder of multiple catalysts that are ahead. After all, the reason for the celebration is:
the successful results for the Company’s lead product candidate Neutrolin® in the Phase 3 clinical study LOCK-IT-100. – quoted from the release.
Looking Back At Phase 3 Data
On January 30, 2019, CRMD issued a press release, announcing the positive results from its Phase 3 LOCK-IT-100 clinical study. The study focused on Neutrolin, a catheter lock solution designed for hemodialysis patients.
The study included 795 subjects and was terminated early as the result of a recommendation of the independent Data Safety Monitoring Board. According to the DSMB, efficacy had been demonstrated early as the pre-specified level of statistical significance had been achieved.
The treatment reached its primary endpoint, leading to a 71% reduction in the risk of occurence of CRBSIs whe compared to the active control of heparin. When it comes to secondary endpoints, there were no significant differences between Neutrolin and the Control arm.
Nonetheless, the primary endpoint was met. Moreover, CRMD said that the emergence of adverse events was lower in the Neutrolin arm than the control arm. In fact, the rate of adverse events per patient in the Neutrolin arm was 5.1 while the control arm had a rate of adverse events per patient of 5.8.
In a statement, Khoso Baluch, CEO at CRMD, had the following to offer:
We are extremely pleased that the analysis of the primary endpoint of the full data set of LOCK-IT-100 confirms and reinforces the results of the interim analysis.
These data add to the growing body of evidence supporting our conclusion that Neutrolin prevents CRBSIs from central venous catheters of patients with end stage renal disease undergoing hemodialysis. We expect to share more information as the analyses of the study data progresses over the coming months.
Catalysts Ahead
Considering the strong Phase 3 clinical data, we can definitively say that there are likely several near-term catalysts ahead. After all, the pivotal study lights the way to a New Drug Application with the FDA.
When the application for Neutrolin is submitted, it will likely act as a positive catalyst in and of itself. Moreover, investors can also look forward to any updates surrounding meetings and other communications with the FDA and the potential approval of the solution. Any of these events could lead to strong gains in the value of CRMD.
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Final Thoughts
It’s great to see that CorMedix is ringing the closing bell today. However, I believe that the strong move that we’re seeing in the value of the stock has more to do with a reminder of the recent data released by the company and the coming catalysts that are likely ahead as a result of the data. All in all, CRMD stock could represent a strong opportunity!
What Do You Think?
Where do you think CRMD stock is headed moving forward? Join the discussion in the comments below!