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OPTN

Optinose

$9.38

0.02 (0.21%)

08:40
12/17/19
12/17
08:40
12/17/19
08:40

Optinose announces publication of results of Phase 3 EXHANCE-3 trial

Optinose announced that results of the Phase 3 EXHANCE-3 trial were published in the peer-reviewed journal Rhinology1, the official journal of the International Rhinologic Society. EXHANCE-3 was part of a comprehensive development program including five clinical trials evaluating XHANCE nasal spray in over 1,500 adult patients; including two randomized, double blinded, placebo controlled Phase 3 pivotal clinical trials in adults with nasal polyposis and two supportive open label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps. Based upon the results of this program, the U.S. Food & Drug Administration approved XHANCE for the treatment of nasal polyps in patients 18 years of age and older in September 2017. EXHANCE-3 was a prospective, multicenter, 12-week, single-arm study evaluating the safety and efficacy of XHANCE 372 mcg twice daily in chronic sinusitis patients with or without nasal polyps. Eligible patients were 18 years of age or older and met diagnostic symptom criteria for CRS. In this study, 705 subjects were enrolled with 92.3% of patients reporting having previously tried corticosteroids and 27.5% reporting prior sinus surgery. All patients received XHANCE 372 mcg twice daily. The majority of spontaneously reported AEs were local in nature, mild in severity, and resolved spontaneously with continued use of XHANCE. The most common AEs included nasal mucosal disorder, spontaneously reported epistaxis, nervous system disorder, and nasal septum disorder. Important efficacy measures in EXHANCE-3 included: Sinonasal Outcome Test-22: At month 1, mean SNOT-22 total scores improved from baseline, with similar improvement in participants with nasal polyps or without nasal polyps of approximately 20 and 21 points, or 46% and 48% respectively. SNOT-22 scores improved more with longer duration of treatment through Month 3. Complete Response Analysis: After 3 months of treatment with XHANCE, approximately 48% of the patients who started the study with polyps were observed to have polyp elimination in at least one nostril. Patient Global Impression of Change: At month 3, 92% of patients with nasal polyps and 89% without nasal polyps reported improvement and 74% with nasal polyps and 68% without nasal polyps reported being ''much'' or ''very much'' improved. Other efficacy measures indicating improvement in this study included Lund-Kennedy endoscopic scoring of observed nasal pathology, indicators of potential need for surgery, and others.

OPTN Optinose
$9.38

0.02 (0.21%)

08/13/19
CANT
08/13/19
NO CHANGE
Target $27
CANT
Overweight
Optinose Q2 'solid,' should bring back optimism, says Cantor Fitzgerald
Cantor Fitzgerald analyst Brandon Folkes says Optinose's "solid" Q2 results last night should bring back Xhance optimism. Despite a "lumpy" initial launch, we are beginning to see Xhance gain traction, which supports confidence in the peak sales potential of the product, Folkes tells investors in a post-earnings research note. He believes increased access, better affordability, the sales force expansion and increased awareness of the "good" efficacy data should continue to drive script growth this year and beyond. The analyst reiterates an Overweight rating on Optinose with a $27 price target.
08/13/19
JEFF
08/13/19
NO CHANGE
Target $21
JEFF
Buy
Jefferies sees valuation 'disconnect' for Optinose amid improving fundamentals
Jefferies analyst David Steinberg believes Optinose's first ever Xhance sales guidance of $29M-$34M for 2019 looks achievable based on the company's "solid" Q2 results and recent prescription trends. Further, $100M in full year 2020 Xhance sales does not seem like a stretch now, Steinberg tells investors in a post-earnings research note. With Optinose's fundamentals continuing to improve, there's increasingly a "disconnect" with the stock's valuation, says the analyst. He keeps a Buy rating on the shares with a $21 price target.
09/24/19
09/24/19
NO CHANGE

Optinose management to meet with RBC Capital
Meetings to be held in Los Angeles/San Francisco, CA on September 24 and in Dallas on September 25 hosted by RBC Capital.
10/01/19
JEFF
10/01/19
NO CHANGE
Target $21
JEFF
Buy
Optinose risk/reward looks increasingly attractive, says Jefferies
After conducting a follow up survey of high prescribing allergists who treat patients with nasal polyps, Jefferies analyst David Steinberg says Optinose's risk/reward looks increasingly attractive. The physician derived survey results imply Optinose's Xhance could generate peak sales of $350M on the low end and $800M-plus with chronic sinusitis on the label, Steinberg tells investors in a research note. However, despite "much improved" script trends following an uneven 2018 launch, the shares have languished, adds the analyst. He keeps a Buy rating on Optinose with a $21 price target.

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