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 […]
Otolaryngology Ear, Nose & Throat
OptiNose sets terms for $100m IPO
OptiNose set terms for its IPO this week, according to a regulatory filing submitted to the SEC. The company plans to offer 6.3 million shares at $15 – $17 apiece and funds affiliated with Avista Capital Partners intend to buy $25 million worth of shares as part of the offering, according to OptiNose. The company […]
OptiNose registers $100m IPO
OptiNose has registered a $100 million initial public offering with the SEC to list its common stock on the Nasdaq market, according to a regulatory filing. The Yardley, Penn.-based company posted a net loss of -$16.3 million in the six months ended June 30, 2017 – down from a $34.3 million net profit during the […]
OptiNose wins FDA nod for Xhance nasal spray
OptiNose said today that the FDA approved its Xhance nasal spray for the treatment of nasal polyps in patients 18 years and older. The fluticasone propionate nasal spray is designed to deliver medication using OptiNose’s exhalation delivery system. The patient actuates the pump spray into one nostril while simultaneously blowing into the mouthpiece of the […]
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 […]
Google backs Decibel Therapeutics in big data hearing loss play
Decibel Therapeutics said today it landed an investment from GV, formerly Google Ventures. GV agreed to make an equity investment in the Boston-based company and lend its capabilities in big data sciences and analytics to Decibel’s efforts in developing therapies for hearing loss and tinnitus. “We are delighted to work with GV to amplify our […]
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 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 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 […]