Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of XOMA (XOMA -3.00%), a clinical-stage biopharmaceutical company geared toward developing monoclonal antibodies for the treatment of metabolic, inflammatory, and cardiovascular diseases, surged by as much as 11% following a press release that provided an update on its EYEGUARD-B trial.
So what: According to XOMA's press release, which came out before the opening bell, its phase 3 EYEGUARD-B trial, which is sponsored by its development partner Servier and is testing experimental drug gevokizumab as a treatment for Behcet's disease, met its exacerbation event target.
In plainer terms, the trial has hit the required number of events such that Servier can begin analyzing the data and can soon report on whether gevokizumab hit its primary endpoint of demonstrating superiority over the placebo in reducing Behcet's disease uveitis exacerbations or not. As the press release notes, the primary endpoint result is expected in "approximately seven weeks," which is a fancy way of telling XOMA shareholders that in less than two months a major catalyst will hit the newswires.
Now what: Today's move isn't a huge surprise, as commentary from management three weeks ago that it was very near reaching its exacerbation event target caused its share price to rise by a double-digit percentage on that day as well. What's really going to matter is whether or not gevokizumab actually works.
If the trial is successful, XOMA plans to file a pre-biologics licensing application with the Food and Drug Administration almost immediately. If approved, XOMA's market potential would be about 7,500 patients in the United States.
Although it's a critical step to get XOMA's first product on pharmacy shelves, it's also important that investors recognize how intricately tied XOMA is to the success of one drug, gevokizumab. In addition to seven clinical studies being run on its own utilizing the drug in the U.S., its partnership with Servier includes five additional trial indications. Essentially, 12 out of 15 preclinical and clinical studies ongoing involve this therapy.
If gevokizumab misses the mark in EYEGUARD-B, XOMA shareholders could take that as a bad sign for the remainder of its pipeline. Let's recall that gevokizumab missed the mark in a previous midstage trial designed to treat patients with erosive osteoarthritis of the hand, so a success is far from a guarantee.
Personally, I'd rather wait this one out on the sidelines, because even if gevokizumab meets its primary endpoint in the EYEGUARD-B trial, you'll have plenty of opportunities to benefit from its 11 other studies involving gevokizumab and the potential sales performance of the drug in the future.