143 results
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
EX-99.1
OPTN
OptiNose Inc
12 May 22
Optinose Reports First Quarter 2022 Financial Results
7:00am
as a potential treatment for Chronic Sinusitis in June 2022
Conference call and webcast to be held today at 8:00 a.m. Eastern Time
YARDLEY, Pa., May 12 … of at least $90 million. Revenue growth and the completion of our clinical trials evaluating XHANCE for treatment of chronic sinusitis are the two most
8-K
EX-99.1
OPTN
OptiNose Inc
13 Jul 22
Optinose Announces that XHANCE Significantly Reduced Incidence of Exacerbations for Patients with Chronic Sinusitis in Landmark ReOpen Program
7:00am
Optinose Announces that XHANCE Significantly Reduced Incidence of Exacerbations for Patients with Chronic Sinusitis in Landmark ReOpen Program …
XHANCE is the first and only nasal medication ever shown in Phase 3 controlled trials
to reduce exacerbations for patients with chronic sinusitis
Pre
8-K
EX-99.1
OPTN
OptiNose Inc
7 Mar 22
Optinose Reports Positive Top-line Results in ReOpen1, a Landmark Phase 3 Trial for XHANCE in Chronic Sinusitis
6:57am
Optinose Reports Positive Top-line Results in ReOpen1, a Landmark Phase 3 Trial for XHANCE in Chronic Sinusitis
XHANCE met both co-primary endpoints … in the ReOpen1 trial, demonstrating statistically significant benefits on symptoms and CT scans in patients with chronic sinusitis
There are no FDA
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
sgj4e5c
13 Jun 22
Optinose Announces Positive Top-line Results of ReOpen2, its second Phase 3 Clinical Trial of XHANCE for Treatment of Chronic Sinusitis
7:01am
8-K
EX-99.2
aks8rg0lm arokj
7 Mar 22
Optinose Reports Positive Top-line Results in ReOpen1, a Landmark Phase 3 Trial for XHANCE in Chronic Sinusitis
6:57am
8-K
EX-99.1
yycnk5fauee1euwr
8 Jul 22
Optinose Announces Additional Positive Results from ReOpen2 and Initial Results from Pooled Analyses of Both Trials in the ReOpen Program
7:00am
8-K
EX-99.1
ntfjm132r6kd4aswa
4 May 23
Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE
7:04am
8-K
EX-99.1
10al84 cki2t2p49fr8
11 Aug 22
Optinose Reports Second Quarter 2022 Financial Results
7:10am
8-K
EX-99.1
4f8 x8nejcxtyaf
10 Nov 22
Optinose Reports Third Quarter 2022 Financial Results
7:01am
8-K
EX-99.1
ikf9m340q5f kcn8av
7 Mar 24
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results
7:00am
8-K
EX-99.2
mu3y2a2b6jz6rl
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
8-K
EX-99.1
f2yp1t7t
14 Mar 22
Other Events
4:48pm
8-K
EX-99.1
cotcvuhg8jlo1b
8 Mar 22
Optinose Reports Fourth Quarter and Full Year 2021 Financial Results
7:01am
8-K
EX-99.1
yy491 kqy4
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
ok8r8p ljqfgmvqm
9 Nov 23
Optinose Reports Third Quarter 2023 Financial Results
7:02am
8-K
EX-99.2
dtavp5204rjhw8 zu0dl
13 Jun 22
Optinose Announces Positive Top-line Results of ReOpen2, its second Phase 3 Clinical Trial of XHANCE for Treatment of Chronic Sinusitis
7:01am
8-K
EX-99.1
o87r y48va3dlici
30 Jul 21
Optinose Completes Patient Recruitment in Pivotal Trial for XHANCE in Chronic Sinusitis
7:55am
8-K
EX-99.1
6rf4zyj
10 Aug 23
Optinose Reports Second Quarter 2023 Financial Results
7:02am