88 results
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
or older.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
Local nasal adverse
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
not typically reached by standard-delivery nasal sprays.
The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally … consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the ReOpen program were epistaxis, headache
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
with chronic rhinosinusitis without nasal polyps to access the safety, efficacy and pharmacokinetics of XHANCE. The Company is required to initiate
8-K
EX-99.1
OPTN
OptiNose Inc
7 Mar 24
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results
7:00am
, the Company announced the publication of peer-reviewed data from the landmark ReOpen program evaluating the efficacy and safety of XHANCE in adult … rhinosinusitis either with or without nasal polyps.
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS
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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9 Nov 23
Optinose Reports Third 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-99.1
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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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4 May 23
Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE
7:04am
8-K
EX-10.1
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15 Dec 22
Optinose Appoints Paul Spence as Chief Commercial Officer
4:45pm
8-K
EX-1.1
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23 Nov 22
Optinose Announces Proposed Public Offering of Common Stock and Warrants
4:09pm
8-K
EX-10.1
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21 Nov 22
Entry into a Material Definitive Agreement
6:16am
8-K
EX-99.2
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10 Nov 22
Optinose Reports Third Quarter 2022 Financial Results
7:01am
8-K
EX-99.1
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10 Nov 22
Optinose Reports Third Quarter 2022 Financial Results
7:01am