136 results
8-K
EX-99.2
OPTN
OptiNose Inc
25 Apr 24
Optinose Provides Corporate Update on XHANCE Launch and Outlook and Announces Preliminary First Quarter 2024 XHANCE Net Revenue of $14.9 million
7:41am
to: the potential benefits of the recent FDA approval of XHANCE for the treatment of chronic rhinosinusitis without nasal polyps (also called chronic … sinusitis); the benefits of XHANCE for the treatment of chronic sinusitis; the benefits of the Exhalation Delivery System; our commercial plans
8-K
EX-99.1
OPTN
OptiNose Inc
25 Apr 24
Optinose Provides Corporate Update on XHANCE Launch and Outlook and Announces Preliminary First Quarter 2024 XHANCE Net Revenue of $14.9 million
7:41am
plans and expectations for XHANCE® (fluticasone propionate) following the recent FDA approval of a new indication for the treatment of chronic … as the first and only approved drug treatment for chronic sinusitis (CS) is a landmark achievement,” said Ramy Mahmoud, MD, MPH, CEO of Optinose. “Because we
8-K
EX-99.1
OPTN
OptiNose Inc
15 Mar 24
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
3:36pm
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
ReOpen … was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis
8-K
OPTN
OptiNose Inc
15 Mar 24
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
3:36pm
and Drug Administration ("FDA") approved its supplemental New Drug Application ("sNDA") for XHANCE for the treatment of chronic rhinosinusitis without nasal … in such a filing.
Item 8.01 Other Events.
On March 15, 2024, the FDA approved the Company's sNDA for XHANCE for the treatment of chronic
8-K
EX-99.1
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7 Mar 24
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results
7:00am
8-K
EX-99.2
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7 Mar 24
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results
7:00am
8-K
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6 Dec 23
Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE
7:02am
8-K
EX-99.1
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6 Dec 23
Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE
7:02am
8-K
EX-99.1
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9 Nov 23
Optinose Reports Third Quarter 2023 Financial Results
7:02am
8-K
EX-99.2
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9 Nov 23
Optinose Reports Third Quarter 2023 Financial Results
7:02am
8-K
EX-99.2
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10 Aug 23
Optinose Reports Second Quarter 2023 Financial Results
7:02am
8-K
EX-99.1
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10 Aug 23
Optinose Reports Second Quarter 2023 Financial Results
7:02am
8-K
EX-99.2
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11 May 23
Optinose Reports First Quarter 2023 Financial Results
7:10am
8-K
EX-99.1
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11 May 23
Optinose Reports First Quarter 2023 Financial Results
7:10am