Fluticasone

Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

Retrieved on: 
Thursday, March 7, 2024

YARDLEY, Pa., March 07, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2023, and provided recent operational highlights.

Key Points: 
  • In addition, during 2023 we worked hard to prepare our organization to make the most of the new opportunity.
  • For the three-month and twelve-month periods ended December 31, 2023, research and development expenses were $1.3 million and $5.3 million, respectively.
  • The net loss for the three-month period ended December 31, 2023 was $10.0 million, or $0.09 per share (basic and diluted).
  • The net loss for the twelve-month period ended December 31, 2023 was $35.5 million, or $0.32 per share (basic and diluted).

Optinose Announces the Publication of ReOpen Phase 3 Clinical Trial Program Evaluating XHANCE in the Journal of Allergy and Clinical Immunology: In Practice

Retrieved on: 
Thursday, January 18, 2024

YARDLEY, Pa., Jan. 18, 2024 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice1.

Key Points: 
  • The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis (chronic rhinosinusitis).
  • “Patients with chronic sinusitis often suffer for years and may use multiple over-the-counter treatments in a search for ways to alleviate their symptoms.
  • Chronic sinusitis is also common: data suggests it is one of the top diagnoses in adult outpatient physician visits.
  • The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile.

Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE

Retrieved on: 
Wednesday, December 6, 2023

YARDLEY, Pa., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.

Key Points: 
  • The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.
  • On November 15, 2023, as part of the ongoing sNDA review, the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1.
  • On December 4, 2023, the FDA notified Optinose that it will require additional time to review this submission (which the FDA deemed a major amendment), and that the PDUFA goal date would be extended to March 16, 2024.
  • The EDS is designed to uniquely deliver drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.

Chronic Rhinosinusitis with Nasal Polyps Market to Witness Upsurge in Growth at a CAGR of 10.03% During the Study Period (2019-2032), Examines DelveInsight

Retrieved on: 
Thursday, December 7, 2023

LAS VEGAS, Dec. 7, 2023 /PRNewswire/ -- DelveInsight's Chronic Rhinosinusitis with Nasal Polyps Market Insights report includes a comprehensive understanding of current treatment practices, chronic rhinosinusitis with nasal polyps emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • Leading chronic rhinosinusitis with nasal polyps companies such as AstraZeneca, Amgen, GlaxoSmithKline, Keymed Biosciences, Biohaven Pharmaceuticals, and others are developing novel chronic rhinosinusitis with nasal polyps drugs that can be available in the chronic rhinosinusitis with nasal polyps market in the coming years.
  • The promising chronic rhinosinusitis with nasal polyps therapies in the pipeline include FASENRA (benralizumab), TEZSPIRE (tezepelumab), Depemokimab/GSK3511294, CM310, NURTEC (rimegepant), and others.
  • Chronic rhinosinusitis is an inflammatory disease of the paranasal sinuses and nasal tube lining that lasts for more than 4 to 12 weeks.
  • To know more about chronic rhinosinusitis with nasal polyps treatment guidelines, visit @ Chronic Rhinosinusitis with Nasal Polyps Management

Chronic Rhinosinusitis with Nasal Polyps Market to Witness Upsurge in Growth at a CAGR of 10.03% During the Study Period (2019-2032), Examines DelveInsight

Retrieved on: 
Thursday, December 7, 2023

LAS VEGAS, Dec. 7, 2023 /PRNewswire/ -- DelveInsight's Chronic Rhinosinusitis with Nasal Polyps Market Insights report includes a comprehensive understanding of current treatment practices, chronic rhinosinusitis with nasal polyps emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • Leading chronic rhinosinusitis with nasal polyps companies such as AstraZeneca, Amgen, GlaxoSmithKline, Keymed Biosciences, Biohaven Pharmaceuticals, and others are developing novel chronic rhinosinusitis with nasal polyps drugs that can be available in the chronic rhinosinusitis with nasal polyps market in the coming years.
  • The promising chronic rhinosinusitis with nasal polyps therapies in the pipeline include FASENRA (benralizumab), TEZSPIRE (tezepelumab), Depemokimab/GSK3511294, CM310, NURTEC (rimegepant), and others.
  • Chronic rhinosinusitis is an inflammatory disease of the paranasal sinuses and nasal tube lining that lasts for more than 4 to 12 weeks.
  • To know more about chronic rhinosinusitis with nasal polyps treatment guidelines, visit @ Chronic Rhinosinusitis with Nasal Polyps Management

Optinose Reports Third Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Thursday, November 9, 2023

YARDLEY, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended September 30, 2023, and provided operational updates.

Key Points: 
  • We are pleased with the progress we made in the third quarter towards our 2023 operating objectives while sharply reducing expenses.
  • Today’s results show that we are outperforming our initial expectations for 2023 XHANCE net revenues while operating far more efficiently and preparing our organization for a successful launch in 2024.
  • Previously, the Company expected XHANCE net revenues for the full year of 2023 to be between $64.0 to $70.0 million.
  • Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

An Old Dog with a New Trick… Ellodi’s APT-1011 Promises EoE Patients a Convenient and Potent Treatment Alternative

Retrieved on: 
Tuesday, August 15, 2023

Moreover, Dupixent continues to enjoy a unique position as the only advanced treatment for EoE.

Key Points: 
  • Moreover, Dupixent continues to enjoy a unique position as the only advanced treatment for EoE.
  • Consequently, an unlikely candidate has emerged as the next significant advancement in EoE, potentially landing the coveted second-to-market position.
  • APT-1011, a reformulation of the commonly used EoE treatment fluticasone, achieved significant improvements in both histologic and symptomatic endpoints.
  • Speaking with physicians in depth, Spherix explored the benefits and implications of APT-1011 when compared to the gold standard EoE treatment, Dupixent.

Optinose Reports Second Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Thursday, August 10, 2023

YARDLEY, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended June 30, 2023, and provided operational updates.

Key Points: 
  • Conference call and webcast to be held today at 8:00 a.m. Eastern Time
    YARDLEY, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended June 30, 2023, and provided operational updates.
  • “We are pleased with the progress we made in the second quarter of 2023 towards our strategic objectives,” stated CEO Ramy Mahmoud, MD, MPH.
  • “That means we are outperforming our initial expectations for full year 2023 XHANCE net revenues while operating far more efficiently.
  • Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

Global BREO Ellipta Drugs Market to Witness Rapid Growth by 2031, Fueled by Growing Chronic Obstructive Pulmonary Disease (COPD) Drugs Market - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 9, 2023

The global BREO ellipta drugs market is driven by the growing chronic obstructive pulmonary disease drugs market, which is likely to grow at a rate of 4.50% during the forecast period of 2023-2031.

Key Points: 
  • The global BREO ellipta drugs market is driven by the growing chronic obstructive pulmonary disease drugs market, which is likely to grow at a rate of 4.50% during the forecast period of 2023-2031.
  • The increasing prevalence of respiratory disorders, such as asthma and COPD, is driving the demand for BREO Ellipta drugs.
  • Advancements in technology and drug delivery systems have played a significant role in the growth of the BREO Ellipta drugs market.
  • BREO Ellipta drugs market has significant applications in the treatment and management of respiratory disorders, primarily chronic obstructive pulmonary disease (COPD) and asthma.