We have reached the end of the week and in the biotechnology space and it has been an incredibly active one. Driven by a variety of catalysts, numerous companies have gained or lost strength on the back of fresh information inputs and we’ve tracked each along the way.
As the week draws to a close, here are two end of the week movers with a look at what is driving the action in each. The two companies in our crosshairs today are Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) and BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX).
So, let’s kick things off with Aerie.
This one is based on a couple of key inputs. On Wednesday, the company announced data from a phase 3 study of its lead development asset in glaucoma, a drug called Roclatan. Aerie had conducted a study called Mercury 2, investigating the impact of Roclatan in the just mentioned glaucoma population when compared to two other drugs, one already marketed by Aerie called Rhopressa and another, the standard of care therapy in the glaucoma space, called latanoprost. We say comparing – that’s not strictly accurate. Roclatan is, in fact, a combination of both Rhopressa and latanoprost, so the aim was to show that a combination of the two drugs can have a higher degree of clinical benefit in the patient population than can either one of these two drugs when used as a monotherapy.
And it turns out, the combination is superior – and by quite a margin. The drug hit on its primary endpoint of statistically significant superiority, with the data showing that Roclatan lowered intraocular eye pressure (IOP), which is the standard severity measure in this population, by between one and three mmHg (IOP measurement units) more than either latanoprost or Rhopressa did on their own.
Aerie, as expected, ran up on the news, as markets loaded up in anticipation of an FDA approval for the drug in this population.
Fast forward 24 hours, however, and the company put out a fresh announcement detailing a $50 million sale of stock in an at-the-market sales agreement in during the Thursday session. When the markets closed, the company further announced it has commenced a registered underwritten public offering of a further $50m of shares of its common stock. Often, these sorts of offering-based announcements will translate to some downside pressure in the share price of the company set to raise funds. Equity raises are dilutive, and markets will generally reevaluate their valuations to accommodate the fresh influx of common stock. In this instance, however, Aerie has managed to hold on to the vast majority of the post-data gains. Markets probably recognize the fact that this sort of capital injection is necessary if the company is to execute on an effective commercialization strategy for the assets in question, and are willing to accept a degree of dilution to ensure any strategy runs smoothly.
Moving on to BioCryst, this one’s a data-driven move.
During the session on Thursday, the company put out data from a second interim analysis of its development asset, BCX7353. The drug is what’s called an oral serine protease inhibitor targeting the enzyme Kallikrein, and it’s targeting the treatment of hereditary angioedema.
We saw initial data from the first stage of a three-stage phase 2 study back in February, and the data looked pretty strong. The latest release details the numbers from the second stage of this phase 2 (as well as a follow-on from the first stage) and – again – the drug looks like it is working. There was a reduction of 73% in overall attack rate in HAE patients with severe disease who were treated with once-daily 125 mg dose of BCX7353 for 28 days.
The final analysis will come when the phase 2 data closes out with stage III numbers, and these are expected to hit press at some point during the third quarter of 2017. If the company can maintain the clinical benefit level we are already seeing as it expands into the third stage (and it is a dose driven expansion, so there is every chance that it will) while maintaining a relatively clean safety profile, chances are we will see BioCryst run further into the end of 2017 and beyond, as the drug moves into pivotal investigations.