ARCA Biopharma Inc (NASDAQ: ABIO) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced the outcome of an end-of-phase 2 meeting with the FDA. Of course, the outcome was positive, sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from ABIO as a result; and
- what we’ll be watching for with regard to the stock ahead.
ABIO Announces Regulatory Update
As mentioned above, ARCA Biopharma is having an incredibly strong start to the trading session this morning after regulatory news broke. In a press release issued early this morning, the company announced that it has received guidance from the United States Food and Drug Administration (FDA). The guidance came by way of the End-of-Phase 2 meeting surrounding the Phase 3 program for the company’s pharmacologically unique beta-blocker, known as Gencaro. Gencaro is a potential genetically targeted treatment for artrial fibrillation patients with heart failure.
In the release, ABIO said that based on the review of the Phase 2 trial results and results from the previous Phase 3 pharmacogenetics study data, the FDA said that data from a single Phase 3 clinical trial may be sufficient to support the approval of Gencaro. As a result, the company has worked with the FDA to establish key elements of the Phase 3 clinical trial that are needed to support a New Drug Application.
Previously, the FDA granted the Gencaro atrial fibrillation development program Fast Track Designation. The FDA suggested that as the result of the program developing what could be the first genetically-targeted cardiovascular therapy, the company should submit an SPA application, which it will do in the third quarter of this year.
In a statement, Michael Bristow, President and CEO at ARCA, had the following to offer:
We are encouraged by the outcome of our End-of-Phase 2 meeting regarding the development path forward for Gencaro and the FDA’s response to the data from our completed Phase 2B GENETIC-AF study… FDA concurrence to proceed into Phase 3 is an important milestone for ARCA and for patients suffering from AF and HF, an indication for which there is a significant unmet medical need and currently no FDA approved therapeutics.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news causes moves. In the case of ARCA, the news proved to be overwhelmingly positive. After all, the meeting with the FDA ended with a clear path to regulatory approval, that didn’t seem like a very long road at all. So, it comes as no surprise to see that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:39), ABIO is trading at $1.10 per share after a gain of $0.29 per share or 35.01% 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 ABIO. In particular, we’re interested in following the story surrounding Gencaro and excited see the treatment progress through the development process. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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