RedHill Biopharma Ltd. (NASDAQ: RDHL) is soaring early on in the pre-market, and for good reason. The company released positive clinical data, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about:
- The clinical data release;
- what we’re seeing from RDHL stock as a result; and
- what we’ll be watching for ahead.
RDHL Releases Clinical Data
As mentioned above, RedHill Biopharma is having a great start to the trading session in the pre-market hours this morning after releasing positive clinical data. In a press release issued early this morning, the company announced positive top-line safety and efficacy results from a Phase 3 clinical trial. In the trial, the company assessed RHB-104 as a treatment for Crohn’s disease.
In the release, RDHL said that the intent-to-treat (ITT) population demonstrated superiority of the treatment over placebo, helping patients to achieve remission at week 26. This proved to be the primary endpoint of the study. Also, the portion of patients that met the primary endpoint was significantly greater in the RHB-104 group than it was in the placebo group with 37% of treated patients reaching remission by week 26 and only 23% of placebo patients reaching remission in the same time frame.
The company also announced that key secondary endpoints were met. First, patients treated with RHB-104 achieved a statistically significant greater response at week 26. These patients also experienced a statistically significant benefit in achieving early remission and maintained a durable remission.
In a statement, Dror Ben-Asher, CEO at RDHL, had the following to offer:
The compelling top-line results with RHB-104, our potential ground-breaking therapy, are a remarkable accomplishment. We thank the patients who participated in this global study, as well as the physicians and clinical staff who supported them. We also want to extend our deep gratitude to the lead investigator of the study, Professor David Graham, to the RedHill team and to the experts and vendors for their commitment throughout the study. We look forward to discussing the path to approval with the FDA and to accelerating discussions with potential pharma partners.
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 causes moves. In the case of RedHill Biopharma, the news proved to be overwhelmingly positive. After all, this data showed that RHB-104 is both effective and safe, and will likely set the stage for a New Drug Application relatively soon. So, it comes as no surprise to see that excited investors are pushing the stock toward the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:15), RDHL is trading at $12.08 per share after a gain of $2.65 per share or 28.10% 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 story surrounding the company’s continued work in the Crohn’s disease space and excited to watch as RHB-104 moves toward a New Drug Application. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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