Intersect ENT (NASDAQ:XENT) slumps 26% premarket on light volume in reaction to unsuccessful results from the randomized ASCEND study evaluating its drug-coated sinus balloon for dilating the frontal sinus ostium to reduce post-balloon dilation edema via the localized delivery of steroid directly to dilated tissue.
The drug-coated sinus balloon failed to beat an uncoated balloon control as measured by sinus patency grade at day 30, the primary endpoint. Several secondary endpoints were met, including reductions in inflammation and polypoid edema.
No safety signals were observed.
The company will further analyze the results before deciding on next steps.
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