Oragenics Inc (NYSEAMERICAN: OGEN) is having a strong morning in the market this morning, and for good reason. The company has received clearance to enroll patients into a clinical trial. As you could imagine, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about the regulatory update, what we’re seeing from OGEN, and what we’ll be watching for ahead.
OGEN Announces Regulatory Update
As mentioned above, Oragenics is having an incredibly strong start to the trading session this morning after providing a regulatory update. In a press release issued early this morning, the company said that it has received clearance to enroll patients into a clinical study.
The approval surrounds patients in Germany and in the United Kingdom. The clinical trial they will be enrolled in is a Phase 3 trial of AG013. AG013 is a live biotherapeutic product that the company is assessing as a potential option for the prevention and treatment of OM.
The Phase 2 trial is ongoing. OGEN designed it as a double-blind, placebo-controlled, two-arm, multi-center trial. Approximately 200 patients will be randomized in a 1:1 ratio to receive either AG013 or a placebo.
Ultimately, the company is using the study to evaluate the safety, tolerability and efficacy of the treatment. The goal is to reduce the incidence and severity of OM in patients that are undergoing traditional chemoradiation for the treatment of head and neck cancer.
OGEN has done relatively well with AG013 to date. First and foremost, the treatment has been granted Fast Track designation by the US FDA. It has also achieved orphan drug status in the European Union.
In a statement, Alan Joslyn, Ph.D., President and CEO at OGEN, had the following to offer:
We are pleased with the receipt of regulatory Health Authority approvals in Germany and the United Kingdom. These approvals provide us with the opportunity to expand the number of clinical trial sites from which we can draw patients to participate in our clinical trial of AG013… The approvals of Germany and the United Kingdom, further enhance our ability to complete the clinical study in 2019.
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 the case of Oragenics, the news proved to be overwhelmingly positive. After all, the company is clear to enroll more patients from different regions into this clinical study. This brings the company one step further down the path of development. So, it’s not surprising to see 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 (9:46), OGEN is trading at $0.95 per share after a gain of $0.06 per share or 6.71% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on OGEN. In particular, we’re interested in following the continued development of AG013 as the company seems to be making impressive progress thus far. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!