Clearside Biomedical, Inc. (NASDAQ:CLSD) is attracting a fair amount of attention in the biotechnology space as we head into a fresh week this week, with the company reporting at the close of last week that it was set to put out data related to one of its lead development assets in around the market open on March 5.
That news has now hit press and the premarket excitement surrounding its release has turned into a flurry of buying activity on the implications of the report.
Here is a look at what happened and what it means for the company going forward.
For those not familiar with this one, Clearside is a Georgia, US-based biotechnology company that focuses on the development of drugs primarily targeting conditions that affect the eye and, specifically, those that lead to blindness.
The company is a small cap based on its current market capitalization (in and around $260 million during the midsession on Monday, March 5) but is one of those entities that, despite its relatively insignificant market capitalization, has been on the radar of a large number of investors for a considerable period based on the fact that it is trying to develop treatments for conditions that, as things stand, don’t really have any treatment options assigned to them (at least, that is, on-label options in the US).
This sort of situation always leads to an outsized degree of media coverage and that is exactly what we are seeing here.
Anyway, back to the present, the data that Clearside just put out relates to a phase 3 trial called PEACHTREE, which was set up to investigate the safety and efficacy of a drug called suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.
That sounds like a pretty complicated target indication but, when you look behind the jargon, it’s actually relatively simple. Uveitis refers to inflammation in the eye that’s caused by the cells and chemicals that comprise the immune system rushing towards the optic nerve and various other optic components. the noninfectious element of the name in this instance refers to the fact that the immune system’s presence is resulting from something like an eye injury or a disease somewhere else in the body, as opposed to an infection of the eye.
Macular edema is the build-up of fluid in the macula, an area in the center of the retina, so ME associated with NIU is the buildup of fluid in the macula that arises as a result of uveitis derived inflammation.
So, with that out of the way, what did the data tell us?
Well, as far as detail is concerned, things are pretty thin on the ground. With that said, however, the important information was present – that the trial hit on both its primary and its secondary endpoints and that the drug was generally seen as safe and tolerable across all 160 patients dosed.
So, what comes next?
As is almost always the case when a company completes a phase 3 trial like this, and does so successfully, it’s now about collecting all the data together and putting it forward as a new drug application (NDA) submission to the relevant authorities – in this instance, the Food and Drug Administration (FDA) in the US.
Here’s what CEO Daniel White said in a statement accompanying the release:
“We currently expect to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and we are also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States”
So, now, markets wait for this submission.
As management has mentioned, it’s expected before the end of this year, meaning we should see a response by the agency (that is, a PDUFA data and an approval or decline decision) before or in and around the third quarter of next year.
As mentioned above, Clearside has picked up some considerable strength on the back of the fresh bit of news, with the company running up to the tune of 33% during the early session on Monday to trade at a price of $10.40 a share.
We’ll likely see a continuation of this strength near term as traders pick up speculative allocations towards Clearside moving into the company’s NDA submission and subsequent decision day in anticipation of a positive result.
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