Shares of Vaxart (NASDAQ:VXRT) were soaring 20.8% as of 11:22 a.m. EDT on Monday. The huge jump came after the biotech announced Food and Drug Administration clearance to begin a phase 1 clinical trial for Vaxart's oral coronavirus vaccine candidate.
Vaxart reported promising pre-clinical results for its oral COVID-19 vaccine candidate in April. But investors really want to see how the investigational vaccine will work in humans. Thanks to the FDA clearance, they're about to get that opportunity.
All of the other novel coronavirus vaccines currently in clinical studies are administered via injection. Vaxart's candidate will be the first vaccine tablet to advance into phase 1 clinical testing.
Should Vaxart's vaccine candidate prove to be safe and effective in human clinical trials, it could have substantial advantages over other coronavirus vaccines. The convenience of administration would be a big plus. Even more important, though, is that Vaxart's oral vaccine doesn't have to be refrigerated, as injectable vaccines do. This means that the company's vaccine would be easier and less costly to transport and store than other COVID-19 vaccines.
CEO Andrei Floroiu said that the company expects to begin enrollment for the phase 1 study of its oral vaccine candidate this month. It will include healthy adults between the ages of 18 and 55.
The biotech stock could enjoy another potential catalyst in the near future as well. Vaxart is awaiting results from a nonhuman primate challenge study of its COVID-19 vaccine candidate that's being funded by Operation Warp Speed, the U.S. government program established to accelerate coronavirus vaccine development.