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Here's What To Watch From Akebia Therapeutics Inc (NASDAQ:AKBA) Right Now

Here's What To Watch From Akebia Therapeutics Inc (NASDAQ:AKBA) Right Now
Written by
Chris Sandburg
Published on
June 23, 2017
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Akebia Therapeutics Inc (NASDAQ:AKBA) registered fresh highs on Wednesday, topping out at just shy of $16 per share mid to late session. The company opened on Thursday at $16.02 a share, representing an 80% premium to its March lows.The action drew the attention of Adam Feuerstein, who noted the highs alongside a number of other companies and biotechnology space with this tweet:

Big list of new highs today: $IMGN $CELG $REGN $VRTX $CLVS $FGEN $AKBA $PTCT $ALNY and more.

— Adam Feuerstein (@adamfeuerstein) June 21, 2017

When a company runs like this and especially at this end of the space, we like to take a look at it to see if the run is hype-driven or whether it has legs.So, here goes.Currently trading with a market capitalization of around $600 million, Akebia is pretty much the definition of a one trick pony. That's not to say that said 'trip' is of no value, but the company really only has one development asset spread across a few different shots on goal, and even these shots on goal are very much in the same ballpark.The asset in question is called Vadadustat and its mechanism of action is pretty interesting. Before getting to that, it's worth noting that the spectrum of target indications are various forms of anemia, which is characterized by lower thanBefore getting to that, it's worth noting that the spectrum of target indications are various forms of anemia, which is characterized by a lower than normal number of red blood cells, resulting in insufficient circulatory-driven oxygen transfer within the body (why this is worth noting will become clear shortly).Another thing worth noting: in our bodies, we have a natural system that responds to high-altitude, low-oxygen environments. It's called the hypoxia response pathway, or HIFα. The activation of HIFα results in short-term increases in respiratory function and longer-term changes in circulatory function, such as an increase in the production of oxygen-carrying red blood cells. This helps the body overcome the comparative lack of oxygen in the atmosphere at high altitude.The current standard of care anemia treatments generally involve administration of what is called erythropoietin, which increases red blood cell count. These work to some degree, but the injections are associated with increased cardiovascular risk.Vadadustat is Akebia's attempt to bring an alternative therapeutic to market – one that doesn't bring with it an increased cardiovascular risk – and it uses, you guessed it, the high altitude response mechanism outlined above. Normally, once a person returns to a standard altitude (one at which oxygen levels are normal), something called HIF-PH gets rid of the HIF proteins that came about on the back of the activation of HIFα pathway.Vadadustat is an HIF-PH inhibitor. It stops HIF-PH from destroying HIF proteins, essentially making the body think it's still at high altitude and – in turn – maintaining the oxygen-boosting side of the natural high altitude response.So, the drug is currently under investigation as part two phase 3 trials, one in non-dialysis patients with anemia related to CKD (NDD-CKD) and another in anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD).It's also in a phase II, as per management's most recent announcement, investigating efficacy in dialysis-dependent chronic kidney disease (DD-CKD) patients who are hyporesponsive to erythropoiesis-stimulating agents (ESAs).These are relatively slow burning trials, with the phase 2 set to readout at some point mid-to-late 2018, and the two phase 3 studies not set to report topline until early 2019. However, there is considerable room for interim release and, in turn, value-driving catalysts between now and topline on all three.As far as recent developments are concerned, the company scored an exclusive licensing deal with the largest dialysis provider in North America back mid-May and just picked up a positive resolution for two patent disputes in Europe, boosting the IP on the MOA of its asset.There's $251 million cash on hand at March 31, and $373 million or more in committed capital from collaborators, which is expected to be received over the course of the global development program for Vadadustat.Bottom line, then, is this: a novel MOA in a population with a large unmet need, plenty of cash to carry the program through to commercialization in at least two separate indications and multiple shots on goal (and catalysts) across the coming twenty-four months. Sure, all of the company's eggs are in one basket with Vadadustat, but there's plenty of run room between now and development program end for this stock, even if the drug doesn’t perform as hoped. If it ends up performing well, this will be a $2 billion play in no time.We will be updating our subscribers as soon as we know more. For the latest updates on AKEB, sign up below!Image courtesy of NASA Goddard via FlickrDisclosure: We have no position in AKEB and have not been compensated for this article.

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