Arca Biopharma Inc (NASDAQ: ABIO) is having an incredibly strong start to the trading session, gaining in multiples in the pre-market. The gains come after the company announced news from the FDA. Of course, the news was positive, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The FDA news;
- what we’re seeing from ABIO stock as a result; and
- what we’ll be watching for ahead.
ABIO Announces FDA News
As mentioned above, ARCA Biopharma is having an incredibly strong start to the trading session in the pre-market after announcing FDA news. In a press release issued early this morning, the company announced that it has reached an agreement with the United States Food and Drug Administration (FDA).
The agreement surrounds a Special Protocol Assessment on the design of a pivotal PHase 3 clinical trial. The goal of the trial, known as PRECISION-AF, is to assess the safety and efficacy of Gencaro TM.
Gencaro TM is a genetically-targeted treatment that’s designed to treat atrial fibrillation in patients with a specific type of heart failure.
This is an area with clear medical need. In fact, the target population for the trial currently has no FDA approved drugs. So, should all go well, Gencaro TM will be the first FDA approved option on the market.
In a statement, Michael R. Bristow MD, PhD, and CEO at ABIO, had the following to offer:
Consistent with our mission to develop precision therapies on a pharmacogenetic platform, this SPA agreement with the FDA provides a clearly defined regulatory pathway for the Phase 3 development of Gencaro in a genotype-specific heart failure population that currently has no FDA approved drug therapy. If the previous foundational therapeutic observations in the GENETIC-AF and BEST trials are confirmed in PRECISION-AF, we believe Gencaro could potentially provide a new standard of treatment for AF prevention for the estimated 2.5 million HFmrEF patients in the major markets in U.S., Europe and Japan.
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 leads to moves. When it comes to ABIO, the news proved to be overwhelmingly positive. After all, the FDA SPA approval means that the company may be incredibly close to submitting a New Drug Application. Should this be the case, the door to revenue will potentially open.
Considering this, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:23), ABIO is trading at $0.78 per share after a gain of $0.39 per share or 101.58% 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 for the Phase 3 trial to begin under the SPA approval by the FDA. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!