RedHill Biopharma Ltd. (NASDAQ: RDHL) is having an incredibly strong start to the trading session thsi morning, and for good reason. The company announced the results of a meeting with the FDA, exciting investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from RDHL as a result; and
- what we’ll be watching for ahead.
RDHL Heads Up On Regulatory Update
As mentioned above, RedHill Biopharma is having a strong start to the trading session this morning after announcing the results of a regulatory meeting. In a press release issued early this morning, the company said that it recently conducted a positive End-of-Phase II/Pre-Phase III (Type B) meeting with the United States Food and Drug Administration surrounding the potential approval of BEKINDA® (RHB-102)1 for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
In the release, RDHL said that in light of the clarity provided by the FDA, it plans on finalizing the design of two pivotal Phase III studies of the treatment. The company also said that it will be accelerating global partnership discussions, including U.S. co-promotion opportunities. In a statement, Gilead Raday, COO at RDHL, had the following to offer:
We are very pleased with the outcome of our meeting with the FDA, which provided clarity on the planned endpoints as well as other important aspects for the design of the pivotal Phase III studies to support potential NDA filing. We believe BEKINDA® could become a leading safe and effective therapy for IBS-D patients and plan to accelerate global pharma partnership discussions, including U.S. co-promotion opportunities.
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. In the case of RedHill Biopharma, the news proved to be overwhelmingly positive. After all, a positive meeting with the FDA means that the company is one step closer to bringing BEKINDA to market. So, it comes as no surprise that excited investors are sending the stock on a run for the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:59), RDHL is trading at $7.60 per share after a gain of $0.40 per share or 5.56% 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 RDHL. In particular, we’re interested in following the continued development of BEKINDA as the treatment seems to be yielding overwhelmingly positive results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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