Akebia Therapeutics Inc (NASDAQ: AKBA) is flying early on in the pre-market hours this morning, and for good reason. The company announced positive results from two separate late-stage clinial trials, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The positive clinical results;
- what we’re seeing from AKBA stock as a result; and
- what we’ll be watching for ahead.
AKBA Climbs On Positive Clinical Results
As mentioned above, Akebia Therapeutics is having a great day in the market today after announcing positive top-line results from two late-stage clinical trials. The data came by way of press release early in the pre-market.
In the release, AKBA provided results from two phase 3 active-controlled pivotal studies through which it evaluated vadadustat. Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Through the studies, Japanese patients with anemia due to chronic kidney disease were treated with the candidate. The studies were performed in collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC).
In one study, the company assessed the treatment in non-dialysis patients. In the second, all subjects in the study were underging hemodialysis.
In the release, the company said that both studies met their primary endpoints adn showed favorable safety and tolerability profiles. As a result, the company expects to submit its NDA in Japan within the current year.
This is overwhelmingly positive news. After all, it is estimated that 13 million people are affected with advanced stages of CKD in Japan, with Anemia being common in patients. At the moment, the standard of care is an injection. However, if approved, Vadadustat will give patients the option to treat anemia with a once-daily oral treatment.
In a statement, John P. Butler, President and CEO at AKBA, had the following to offer:
Collectively, these data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anemia due to CKD.
These results add to our dataset demonstrating the potential for vadadustat to effectively manage hemoglobin levels in both dialysis-dependent and non-dialysis dependent patients, including those who convert from erythropoiesis stimulating agents.
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 Akebia Therapeutics, the news proved to be overwhelmingly positive.
After all, with the strong data from two late-stage trials, the company now has the evidence it needs in order to submit an NDA in Japan. Moreover, the company said that it plans on doing so in the current year, outlining the path for several catalysts ahead.
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 (7:52), AKBA is trading at $9.90 per share after a gain of $2.56 per share or 34.88% 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 AKBA. In particular, we’re interested in following the story surrounding the comapny’s continued work to bring vadadustat to market in Japan and other regions around the world. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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