ContraVir Pharmaceuticals Inc (NASDAQ: CTRV) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has been granted Orphan Drug Designation with regard to a key clinical candidate. Today, we’ll talk about the news, what we’re seeing from CTRV, and what we’ll be watching for ahead.
CTRV Granted Orphan Drug Designation
As mentioned above, ContraVir Pharmaceuticals is doing overwhelmingly well early on in the market today after announcing that it has been granted Orphan Drug Designation. In a press release issued early this morning, the company announced that the United States Food and Drug Administration, also known as FDA, has granted Orphan Drug Designation to its lead investigational drug candidate. The candidate, known as tenofovir exalidex (TXLTM), is designed for the treatment of chronic hepatitis B infection in a pediatric patient population with ages ranging from 0 to 11 years old.
The Orphan Drug Designation is big news for CTRV. Ultimately, this means that the company will have more communication with the FDA with regard to pushing this thing to the market as well as a faster review period. On top of that, the company will pay less and get more when it comes to applying for regulatory approval from the FDA surrounding the treatment. In a statement, James Sapirstein, CEO at CTRV, had the following to offer:
We are very pleased to report that TXL is currently the only investigational or approved HBV treatment granted orphan designation for the pediatric patient population… This designation underscores the significant unmet need in this highly vulnerable patient population and provides a critical development path for TXL to bring to market a new treatment option for this under-served patient population. As we previously reported the agreement with FDA on the 505(b)(2) registration pathway for TXL, we have achieved yet another important regulatory milestone, and we look forward to continued collaboration with the FDA addressing the urgency of successfully developing treatments for hepatitis B in the pediatric and adult populations.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dabble in the market is that the news causes moves. With such positive news released by ContraVir Pharmaceuticals, we’re seeing strong gains in the value of the stock today. Of course, our partners at Trade Ideas were the first to alert us to the movement. At the moment (9:58), CTRV is trading at $0.29 per share after a gain of $0.05 per share (19.19%) 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 CTRV. In particular, we’re interested in following the TXL drug candidate, as recent news surrounding it seems to be overwhelmingly positive. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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