Fibrocell Science Inc (NASDAQ: FCSC) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that it has received guidance from the FDA with regard to a Phase 3 clinical trial. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The guidance;
- what we’re seeing from FCSC stock as a result; and
- what we’ll be watching for ahead.
FCSC Gains On FDA Guidance
As mentioned above, Fibrocell Science is having an incredibly strong start to the trading session after announcing FDA news. In a press release issued early this morning, the company said that it has completed a Type C meeting with the United States Food and Drug Administration. The meeting surrounded the design of a Phase 3 clinical trial of FCX-007. FCX-007 is an investigational therapy designed for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
In the release, FCSC said that the FDA has provided guidance on various design aspects of the company’s proposed Phase 3 clinical trial. Also, the company said that it was provided with guidance on Chemistry, Manufacturing and Control requirements for the Phase 3 trial. In a statement, John Maslowski, President and CEO at FCSC, had the following to offer:
We appreciate the valuable and detailed guidance furnished by the FDA on the design of the proposed Phase 3 clinical trial and advice on CMC requirements… We look forward to finalizing the Phase 3 protocol design, and plan to initiate the Phase 3 clinical trial in the first half of 2019.
What We’re Seeing From The Stock
As investors, one of the most important lessons that we learn is that it’s important to keep a close eye on the news. After all, the news does lead to moves in the market. In the case of Fibrocell Science, the news proved to be overwhelmingly positive. As a result of the FDA meeting, it looks like the Phase 3 trial will be underway relatively soon. So, it comes as no surprise to see that excited investors are pushing the stock up in the market this morning. At the moment (8:20), FCSC is trading at $2.10 per share after a gain of $0.15 per share or 7.69% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on FCSC. In particular, we’re interested in following the story surrounding the company’s continued work to bring FCX-007 to market as the company is on track to move forward with a pivotal trial relatively soon. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!