SIGA Technologies, Inc. (NASDAQ: SIGA) is having an overwhelmingly strong start to the trading session this morning after announcing a favorable outcome surrounding a U.S. Food and Drug Administration Advisory Committee meeting. Of course, with the positive clinical update in mind, investors are excited, sending the stock screaming for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from SIGA as a result;
- and what we’ll be watching for ahead.
SIGA Provides Clinical Update
As mentioned above, SIGA Technologies is having an incredibly strong start to the trading session after announcing a clinical update. In a press release issued early this morning, the company announced a favorable outcome of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee meeting surrounding the company’s candidate, TPOXX®. The treatment is designed for to treat smallpox and is known as a small molecule antiviral treatment. In the release, SIGA said that the panel consisted of various independent medical experts who voted unanimously that the benefit of TPOXX® outweighed the risks. In a statement, Dr. Phil Gomez, CEO at SIGA, had the following to offer:
We are pleased that the advisory panel believes strongly in the benefits of TPOXX. We are confident that the robust data package and safety profile with no drug-related serious adverse events positions TPOXX for favorable FDA review of its pending New Drug Application (NDA)… The support of the independent medical experts that comprise the advisory committee panel provides valuable additional feedback reflecting the strength of our application for TPOXX. We believe that safety and efficacy data contained in the NDA support TPOXX’s future use as a medical countermeasure in response to a smallpox outbreak.
TPOXX® is currently under review with the FDA. According to the PDUFA date assigned to the New Drug Application, investors should know whether or not the FDA is ready to approve the treatment by no later than August 8th of this year.
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 it’s important to keep a close eye on the news. After all, the news moves the market. In the case of SIGA Technologies, the news proved to be overwhelmingly positive. So, it’s no surprise to see that the stock is making a run for the top in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:42), SIGA is trading at $6.50 per share after a gain of $0.61 per share or 10.36% 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 SIGA. In particular, we’re interested in following the story surrounding TPOXX® as the treatment is likely just a few months from approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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