Synthetic Biologics Inc (NYSEAMERICAN: SYN) is having an incredibly strong start to the trading session this morning, and for good reason. The comapny announced a successful meeting with the FDA, leading to excitement among investors and sending the stock on a run for the top. Today, we’ll talk about the FDA meeting, what we’re seeing from SYN as a result, and what we’ll be watching for ahead.
SYN Announces Positive Outcome From FDA Meeting
As mentioned above, Synthetic Biologics is having an incredibly strong start to the trading session this morning after the company announced the completion of an FDA meeting. In a press release issued early this morning, SYN said that it has successfully completed the End of Phase 2 meeting with the FDA to discuss the development of SYN-004.
SYN-004 is being developed by the company for the prevention of antibiotic-mediated Clostridium difficile infection (CDI). In the release, the company said that the FDA has proposed criteria for the Phase 3 clinical study. This criteria is focused on safety and efficacy and if the company achieves its endpoints, the data will support the submission of an NDA for ribaxamase on the basis of the Phase 3 trial.
From here, it’s up to SYN to move forward with trial design. After all, final greement on the Phase 3 study criteria is contengent on n FDA evaluation of the detailed Phase 3 clinical trial protocol. In a statement, Steven A. Shallcross, Interim CEO at SYN, had the following to offer:
We are very pleased with the productive advice we have received from the FDA during our recent End-of-Phase 2 meeting… Having a clear path forward in the form of a Phase 3 clinical program for ribaxamase is an exciting and important milestone for our company and should be highly beneficial in our ongoing strategic partnering discussions.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. When it comes to Synthetic Biologics, the news proved to be overwhelmingly positive. After all, the end-of-phase 2 meeting completion brings the company one step closer to achieving marketing approval for SYN-004 (ribaxamase). Now, with a clear path set forth for the design of Phase 3 protocol, the company is well on its way to late-stage development of the treatment, meaning that it could start generating revenue reltively soon. So, it comes as no surprise that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:36), SYN is trading at $0.94 per share after a gain of $0.18 per share or 22.88% 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 SYN. In particular, we’re interested in following the story surrounding the company’s continued work to bring ribaxamase to market as the treatment is quickly pushing into late-stage development. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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