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XENT

Intersect ENT

$16.60

0.1 (0.61%)

08:03
10/17/16
10/17
08:03
10/17/16
08:03

Intersect ENT reports RESOLVE II study met both primary efficacy endpoints

Intersect ENT announced results from RESOLVE II, a randomized, blinded, multi-center clinical trial designed to assess the safety and efficacy of the company's investigational RESOLVE steroid releasing implant. The RESOLVE II pivotal phase III study evaluated the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation. Patients were randomized to one of two groups: a treatment group consisting of bilateral RESOLVE implant placement in the office, or a control group consisting of a sham procedure. The study met both co-primary efficacy endpoints. An independent panel of surgeons blinded to treatment assignment evaluated the change in mean bilateral polyp grade from baseline to day 90 based on video endoscopies. A statistically significant difference in mean change from baseline favoring the treatment group was observed. The change in mean Nasal Obstruction/Congestion score was measured from baseline to day 30, as scored by patients using a daily diary. A statistically significant difference in mean change from baseline favoring the treatment group was observed. Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal obstruction, and total symptom score. Safety was evaluated by endoscopic examination and evaluation of adverse events. One serious device-related adverse event, an intranasal bleed requiring intervention, was observed. Intersect ENT plans to submit a New Drug Application, or NDA, in the first quarter of 2017 for regulatory approval from the U.S. FDA to market the RESOLVE product.

  • 17

    Nov

  • 29

    Nov

XENT Intersect ENT
$16.60

0.1 (0.61%)

05/06/16
WEDB
05/06/16
NO CHANGE
WEDB
Intersect ENT post-earnings weakness an overreaction, says Wedbush
Wedbush believes that nothing has really changed in the story for Intersect ENT based on the company's quarterly report and thinks today's selloff is an overreaction.
05/20/16
PIPR
05/20/16
NO CHANGE
Target $23
PIPR
Overweight
Intersect ENT selloff feels like an overreaction, says Piper Jaffray
After meeting with Intersect ENT's CEO Lisa Earnhardt, Piper Jaffray analyst Matt O'Brien says the recent pullback in the shares "feels like a bit of an overreaction." The company's sales force has stabilized and Q2 and Q3 revenue estimates look achievable, O'Brien tells investors in a research note. Further, with $4 per share in cash and no debt, Intersect's current stock price implies little, if any, value to its pipeline of products, the analyst argues. He keeps an Overweight rating on the shares with a $23 price target.
08/25/16
PIPR
08/25/16
NO CHANGE
PIPR
Intersect ENT should be owned at current levels, says Piper Jaffray
After meeting with Intersect's management, Piper Jaffray analyst Matt O'Brien says that recent "negative issues" involving sales force disruptions and reimbursement are not "hurting the company much." The analyst says that the company has several growth drivers, and he predicts that they will enable the company's revenue to increase about 20% over the next several years. O'Brien says that the decline in the stock this year is overdone, and he keeps a $21 price target and Overweight rating on the shares.
10/06/16
DBAB
10/06/16
INITIATION
Target $17
DBAB
Hold
Intersect ENT initiated with a Hold at Deutsche Bank
Deutsche Bank analyst Brittany Henderson started Intersect ENT with a Hold rating and $17 price target. The analyst believes risk around the company's execution and reimbursement offsets its differentiated product platform in the near term.

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