Shares in Intersect ENT (NSDQ:XENT) held steady today after the company reported preliminary data for its fourth quarter and full-year revenues. The Menlo Park, Calif.-based company said it expects to reel in $96.1 – $96.3 million in revenue for the full year of 2017, up 22% from 2016. Intersect also pegged its fourth-quarter revenue between $29.3 […]
Intersect ENT Inc.
Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant
Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]
FDA conducts pre-approval inspection for Intersect ENT’s Menlo Park facility
Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 […]
Intersect ENT beats Q3 sales estimates, raises full-year forecast
Shares in Intersect ENT (NSDQ:XENT) rose slightly today after the steroid-eluting implant maker beat sales expectations on Wall Street with its third quarter results. The Menlo Park, Calif.-based company posted a net loss of -$4.3 million on sales of $22.3 million for the 3 months ended Sept. 30, for sales growth of 21% compared with the […]
Intersect ENT touts results from pivotal study of steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) touted data this week from the pivotal Resolve II trial of its investigational steroid-releasing sinus implant, Sinuva. The Phase III trial evaluated Sinuva in 300 adult chronic sinusitis patients, who were all indicated for revision sinus surgery at study entry due to recurrent, medically refractory symptoms and bilateral nasal polyposis. Study participants were […]
Intersect ENT touts meta-analysis of steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) touted data today from a meta-analysis of two studies assessing the safety and efficacy of its investigational steroid-releasing sinus implant, Sinuva. The studies evaluated Sinuva in patients with recurrent and medically refractory nasal polyps. The meta-analysis, which was presented at the American Rhinologic Society’s annual meeting, included data from the Resolve and Resolve […]
Intersect ENT tops EPS, sales estimates in Q2
Shares in Intersect ENT (NSDQ:XENT) surged today after the drug-device company beat expectations on Wall Street with its second quarter results. The Menlo Park, Calif.-based company posted a loss of -$2.3 million on sales of $24 million for the 3 months ended June 30, for bottom-line growth of 62% on sales growth of 24% compared […]
Intersect ENT updates on Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for […]
Intersect ENT beats Q1 earnings, rev forecast
Shares in Intersect ENT (NSDQ:XENT) fell slightly yesterday after the drug-device maker met expectations on Wall Street with its 1st quarter results. The Menlo Park, Calif.-based company posted a loss of -$6.8 million, or -23¢ per share, on sales of $20.5 million for the 3 months ended March 31, for bottom-line growth of 20% on sales growth of 22.8% […]
Intersect ENT seeks FDA nod for Resolve steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it submitted a New Drug Application to the FDA for its Resolve steroid-releasing implant to treat chronic sinusitis patients with recurrent sinus obstruction. The Menlo Park, Calif.-based company’s implant can be placed during a routine physician office visit and is designed to be a less invasive treatment option for recurrent […]
