CorMedix Inc. (NYSEAMERICAN: CRMD) is having a strong start to the trading session this morning, and for good reason. The company announced that the United States Food and Drug Administration has granted orphan drug designation surrounding one of their treatment candidates. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for ahead.
CRMD Granted Orphan Drug Designation
As mentioned above, CorMedix is having an incredibly strong day in the market today after announcing that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) surrounding one of their pipeline treatments. In a press release issued early this morning, CRMD announced that it received a notification from the FDA on Friday, February 23, 2018, letting the company know that the FDA has granted Orphan Drug Designation to taurolidine for the treatment of neuroblastoma. Taurolidine is a key component of the company’s lead product, Neutrolin®. The treatment is a novel anti-infective solution for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in end-stage renal disease. In a statement, Khoso Baluch, CEO at CRMD, had the following to offer:
We are pleased to expand on our potential indications for taurolidine and to receive orphan drug designation for treatment of neuroblastoma… We believe taurolidine could have potential activity in this rare pediatric disease area, based on ongoing laboratory studies. Current treatments offer poor outcomes and bsed on its potential synergy with other drugs approved in this area, we believe taurolidine could become an important therapy for neuroblastoma. Our goal in this area is to partner with an appropriate cancer-focused company to advance taurolidine into clinical development and ultimately obtain marketing approval.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news surrounding CorMedix proved to be overwhelmingly positive. After all, Orphan Drug Designation means that the company will have a faster path toward regulatory approval of the treatment as well as the benefit of having more interaction with the FDA throughout the development process. So, it’s no surprise to see that the stock is having a great start in the pre-market hours. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:18), CRMD is trading at $0.34 per share after a gain of $0.02 per share (5.02%) 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 ongoing development of taurolidine and excited to watch as the company continues to expand on the indications of the treatment. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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