Optinose Inc.’s shares dropped ahead of the opening bell Monday, eating into strong gains so far this year, after the specialty-pharmaceutical company said it saw positive top-line results from a late-stage trial of XHANCE for chronic sinusitis.
In premarket trading, the shares were 7.7% lower after ending Friday at $2.72. They have rallied 68% in 2022.
Optinose, which is scheduled to release its fourth-quarter financial results Tuesday, said its Phase 3 trial met both of its co-primary endpoints. The study showed statistically significant improvement in patients with chronic sinusitis who were treated with the XHANCE Exhalation Delivery System compared with patients receiving an exhalation delivery system placebo, with benefits on symptoms and CT scans in patients.
Chronic sinusitis is a common, difficult-to-treat disease that often leads to severe sinus symptoms requiring repeated courses of antibiotics, among other treatments. There are no Food and Drug Administration-approved drug treatments for the 30 million adults in the U.S. with chronic sinusitis, Optinose said.
The top-line results from the second of its two Phase 3 trials for Xhance in chronic sinusitis are expected in the second quarter, the company said.
Analysts polled by FactSet have forecast a fourth-quarter loss of 28 cents a share for Optinose, narrower than the 46 cents recorded for the year-earlier period, and sales of $21.8 million, unchanged from the period quarter but up from $16.3 million the year before.