CorMedix Inc. (NYSEAMERICAN: CRMD) is flying in the market yet again today after seeing considerable gains over the past few trading sessions. So, what’s the deal? Ultimatley, the gains started after the company announced a clinical update, leading to excitement among investors that is clearly continuing in the market as we speak. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from CRMD as a result; and
- what we’ll be watching for ahead.
CRMD Continues Up On Last Week’s Clinical Update
As mentioned above, CorMedix is having an incredibly strong start to the trading session this morning, following up on massive gains that we’ve seen for about a week now. The gains are the result of a clinical update that was offered last week. In a press release, the company announced that the independent Data Safety Monitoring Board (DSMB) has completed its review and interim analysis of data from the Phase 3 LOCK-IT-100 study. The news proved to be overwhelmingly positive.
In the release, CRMD announced that the DSMB recommended that the study be terminated early, but not for adverse effects or concerns. Instead, the recommendation came as a result of pre-specified levels of statistical significance being reached early. As a result, the company is ceasing the study and submitting the results to the United States Food and Drug Administration (FDA) for its review. Ultimately, this pushes the time lin up in a big way as the company will not have to move forward with the completion of the study. It also shows that the data is overwhelmingly positive. If the DSMB is confident that it has evidence of efficacy, safety and tolerability, and that confidence is enough to say “OK, let’s stop the trial now, we’re ready for next steps,” that confidence is a big red sign saying “Approval is likely on the way.”
Nonetheless, in a statement, Khoso Baluch, CEO at CRMD, had the following statement to offer with regard to the news:
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
Following a tremendous rise in value of the past few sessions, CorMedix is making yet another run for the top early on in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:51), CRMD is trading at $0.66 per share after a gain of $0.15 per share or 28.53% 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 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!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!