Soligenix, Inc. (NASDAQ: SNGX) 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 from the European Medicines Agency. Of course, this led to excitement among investors, sending the stock rocketing for the top. Today, we’ll talk about the designation, what we’re seeing from SNGX, and what we’ll be watching for ahead.
SNGX Flies On Orphan Drug Designation
As mentioned above, Soligenix is having an overwhelmingly strong start to the trading session this morning after announcing that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medical Products, has granted orphan drug designation to the company’s drug. The designation surrounds the recombinant modified ricin toxin A-chain subnit for the prevention of ricin poisoning. Ultimately, this designation targets the active pharmaceutical ingredient in RiVax®, a treatment that has previously been granted orphan drug designation from the United States Food and Drug Administration.
This is overwhelmingly positive news for SNGX. After all, this designation is only given to treatments for life-threatening or chronically debilitating conditions affecting no more than five in 10,000 consumers in the EU and where no satisfactory treatment is available. As a result of the designation, the company will see a longer exclusivity period in the EU as well as other incentives on the path toward and following the potential approval of the treatment. In a statement, Christopher J. Schaber, PhD, President and CEO at SNGX, had the following to offer:
We are extremely pleased to have received European orphan drug designation for the RiVax® program… This EU orphan designation, combined with our US orphan designation, positions this biodefense program for a potentially accelerated global regulatory product development pathway to address this unmet need. RiVax® has shown up to 100% protection against aerosolized ricin exposure in non-human primates and safety in humans and we look forward to further developing our thermostable formulation for human use.”
What We’re Seeing From The Stock
One of the first lessons that we learn as investors is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. After all, Soligenix already had Orphan Drug Designation and all the benefits it provides in the United States. Now, with today’s news, that designation expands to Europe. So, it’s no surprise to see such strong movement in the value of the stock today. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:55), SNGX is trading at $2.54 per share after a gain of $0.54 per share or 26.85% 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 SNGX. In particular, we’re interested in following the continued development of RiVax® as the Orphan Drug Designation news brings the potential value of the treatment to new highs. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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