CorMedix Inc. (NYSEAMERICAN: CRMD) is having a great start to the trading session in the pre-market hours this morning after the company announced positive clinical data. Of course, the positive data excited investors, sending the stock screaming for the top. Today, we’ll talk about:
The clinical results;
what we’re seeing from CRMD; and
what we’ll be watching for ahead.
CRMD Announces Phase 3 Results
As mentioned above, CorMedix is having an incredibly strong start to the trading session today after providing a clinical update. In a press release issued early this morning, the company announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of data. The data came from the ongoing Phase 3 Lock-It-1– clinical study assessing Neutrolin®
In the release, CRMD said that because the pre-specified level of statistical significance was reached and efficacy has been demonstrated, the DSMB recommended ending the study early. The company said that no safety concerns were reported by the DSMB based on the interim analysis. As a result, the company plans on submitting the results of the interim analysis to the United States Food and Drug Administration for review.
In a statement, Khoso Baluch, CEO at CRMD, had the following to offer:
We are thrilled to have received the DSMB’s recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB’s recommendation to the FDA, we will begin the dialogue on the appropriate next steps… We have invested a significant amount of the Company’s resources over the last 2 ½ years in this study, and it is gratifying to have achieved this result based on the interim analysis. We believe Neutrolin has great potential to save lives of patients receiving hemodialysis therapy as a treatment for end-stage renal disease and to lower overall healthcare costs due to reducing the risk of catheter-related blood stream infections (CRBSI).
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 causes moves. In the case of CRMD, the news proved to be overwhelmingly positive. After all, positive clinical data pushes the company one step closer to regulatory approval of Neutrolin®. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:56), CRMD is trading at $0.42 per share after a gain of $0.15 per share or 51.79% thus far today.
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 following the news of the positive results. Nonetheless, we’ll continue to follow the news closely and bring it to you as it breaks!
