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 […]
intersectent
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 same period last […]
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. Get the full […]
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 with the […]
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 […]
Intersect ENT reels in losses, beats revenue estimates for Q4
Shares in Intersect ENT (NSDQ:XENT) fell slightly today even though the drug-device company met expectations on Wall Street with its 4th quarter results. The Menlo Park, Calif.-based company pared losses to -$4.8 million, or -17¢ per share, on sales of $24.2 million for the 3 months ended Dec. 31, for bottom-line growth of 15.8% on sales growth […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT(NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. Get the full story at […]
Intersect ENT shares jump on Q4 prelims
Intersect ENT (NSDQ:XENT) shares jumped yesterday 11% to reach a peak of $13.20 apiece after the company released its preliminary financial results for the 4th quarter, narrowly beating analysts’ expectations on Wall Street. The Menlo Park, Calif.-based company said it expects a total revenue of $24.o – $24.2 million for Q4, slightly ahead of the […]