Here’s What’s Happening With Akebia Therapeutics Inc (NASDAQ:AKBA) and Epizyme, Inc. (NASDAQ:EPZM)


Here’s a look at two of the biggest movers in the biotechnology space so far this week, with a discussion of what’s moving each, and where we’re looking at both companies moving as we head into the second half of the week.

Story continues below

The two companies in our crosshairs today are Akebia Therapeutics Inc (NASDAQ:AKBA) and Epizyme, Inc. (NASDAQ:EPZM).

First up, then, Akebia.

This one is a bit of good news for the company and its shareholders. The company was trading for a little over $9 a piece at close of market on Tuesday, having run pretty flat (if not a little down) for the majority of the year to date. After the markets closed, however. Akebia put out a release detailing the expansion of a partnership rooted in its lead anemia drug, and the announcement got things moving. Pre market on Wednesday, and rooted in a combination of after hours and early morning activity, Akebia is trading at $12.22 a piece – a more than 30% gain on the company’s yesterday-close.

So what’s happened?

The company has an agreement in place with a Japanese entity called Otsuka Pharmaceutical Co., which details the joint development of a drug called Vadadustat in the US. As noted, it’s an anemia target, and it’s long been one of the more promising assets in Akebia’s relatively deep pipeline.

The initial agreement, which the two companies first announced at the end of last year, saw Otsuka cough up $265 million in committed funds, and allowed for up to $765 million in milestone payments.

As per the latest announcement, the companies have now agreed to expand the initial collaboration deal – an expansion that sees Otsuka take charge of the commercialization efforts in Europe, China and other territories, and pay up to 30% royalties to Akebia for the privilege. Further, and in line with the initial collaboration deal, Akebia is also set to receive an upfront cash infusion to the tune of $208 million, as well as up to $657 million in milestone payments.

The importance of this is that the company now has partnerships in place to cover the two largest markets for the drug – the US and Europe – and this alleviates a large portion of the dilution risk associated with an investment in a company at this end of the biotechnology space. Lifted dilution risk is a great think, and that’s why the company is running up as it is on the news.

So where do we expect things to go from here?

Well, the drug has to get through the development phase and pick up a green light from the regulatory authorities in the respective regions if it is to bring in the royalties promised, but data to date has been strong, and that an entity like Otsuka is willing to up the ante and double down on its upfront payments for European rights suggests there’s a good chance that regulatory approval will come – these company’s don’t spend hundreds of millions of dollars without performing their due diligence.

As such, we expect wider markets to load up on the company ahead of any regulatory decision, and by proxy, we expect Akebia to gain strength going forward.

Ok then, now let’s look at Epizyme.

This one’s another bit of good news. Epizyme is developing a drug called tazemetostat, in a target indication of relapsed or refractory follicular lymphoma. The drug is in a phase II investigation right now, and it’s one of the company’s most closely watched assets/programs from a market potential perspective.

On Tuesday, management put out a press release noting a couple of key developments for the drug. The first, that the FDA has designated the drug as Fast Track. This designation brings with it a host of regulatory pathway benefits, perhaps most notably the opportunity for rolling submission, and should shorten the drug’s development pathway. A shortened pathway means less cost, which in turn means less dilution. Less dilution means less risk from a shareholder perspective, and makes the company more attractive as an exposure option.

The second announcement is that data from the phase II mentioned above will be presented on Wednesday, June 14, 2017 at 2:00 p.m. CET at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. This is a big date on the lymphoma calendar, and that management is happy to put out data at the event is a good sign.

Again, we expect this one to run up ahead of the data date.

An ad to help with our costs