OPTN

Optinose to Present at the Needham Virtual Healthcare Conference

Retrieved on: 
Thursday, April 4, 2024

YARDLEY, Pa., April 04, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that members of its management team will present a company overview and business update at the Needham Virtual Healthcare Conference on April 10, 2024 at 2:15 p.m.

Key Points: 
  • YARDLEY, Pa., April 04, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that members of its management team will present a company overview and business update at the Needham Virtual Healthcare Conference on April 10, 2024 at 2:15 p.m.
  • ET.
  • To listen to a webcast of the presentation live, please visit the Investors page of the Optinose website.
  • A replay of the webcast will be available for 30 days following the conclusion of the event.

Valeos Welcomes Dr. Stuart Sweet to Board of Directors

Retrieved on: 
Tuesday, April 9, 2024

WASHINGTON, April 9, 2024 /PRNewswire/ -- Valeos, a 501(c)(3) nonprofit organization designed to improve organ transplant outcomes for patients and organ donors through data collaboration, today announced the appointment of Dr. Stuart C. Sweet, MD, PhD to its Board of Directors. Dr. Sweet is the W. McKim Marriott Professor of Pediatrics at Washington University in St. Louis, MO, and served as the 2016-2017 Board President of the Organ Procurement and Transplantation Network (OPTN), the U.S. national transplant system. Dr. Sweet spent more than two decades as the medical director of the pediatric lung transplant program at Washington University School of Medicine in St. Louis and St. Louis Children's Hospital, focusing clinically on pediatric lung transplantation and gaining expertise in organ allocation, clinical outcomes, health policy and the role of information technology in medicine.

Key Points: 
  • "I am honored to join the exceptional team at Valeos and continue my dedication to advancing the U.S. organ transplant system," said Dr. Sweet.
  • "We're excited to welcome Dr. Sweet to our Board of Directors.
  • This announcement follows an exciting year for Valeos, which saw its first appointments to its Board of Directors and Advisory Committee this past January.
  • With the backing of leading figures in healthcare, technology and government, Valeos is committed to building the world's largest de-identified transplant data sandbox.

XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

Retrieved on: 
Friday, March 15, 2024

YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.

Key Points: 
  • Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States.
  • Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine.
  • Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine.
  • Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually.

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 Reporting Date for Fourth Quarter 2023 Financial Results

Retrieved on: 
Thursday, February 29, 2024

YARDLEY, Pa., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will report financial results for the fourth quarter 2023 and corporate updates, before market open on Thursday, March 7, 2024.

Key Points: 
  • YARDLEY, Pa., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will report financial results for the fourth quarter 2023 and corporate updates, before market open on Thursday, March 7, 2024.
  • Members of the Company’s leadership team will host a conference call to discuss financial results and corporate updates.
  • The call is scheduled to start at 8:00 a.m. Eastern Time on Thursday, March 7, 2024.
  • In addition, a replay of the webcast will be available on the Company website for 60 days following the event.

National Kidney Foundation Recognizes March as National Kidney Month

Retrieved on: 
Thursday, February 29, 2024

NEW YORK, Feb. 29, 2024 /PRNewswire/ -- As March approaches, the National Kidney Foundation (NKF) is gearing up to observe National Kidney Month, a crucial time dedicated to raising awareness about kidney health and chronic kidney disease (CKD). With World Kidney Day falling on Thursday, March 14th, this month holds particular significance in advocating for KIDNEY EQUITY FOR ALL™.

Key Points: 
  • NEW YORK, Feb. 29, 2024 /PRNewswire/ -- As March approaches, the National Kidney Foundation (NKF) is gearing up to observe National Kidney Month, a crucial time dedicated to raising awareness about kidney health and chronic kidney disease (CKD).
  • With World Kidney Day falling on Thursday, March 14th, this month holds particular significance in advocating for KIDNEY EQUITY FOR ALL™ .
  • "Despite this, they are exposed to inequities in kidney care including evaluation and obtaining a kidney transplant.
  • To mark National Kidney Month and World Kidney Day, NKF is highlighting several ways the organization is promoting kidney equity.

U.S. Organ Procurement Organizations are Strong, CMS Rule Threatens Future Success of Donation System

Retrieved on: 
Thursday, February 8, 2024

Under new performance metrics established by CMS, an estimated 42% of the nation’s nonprofit organ procurement organizations (OPOs) could be decertified and dissolved in 2026.

Key Points: 
  • Under new performance metrics established by CMS, an estimated 42% of the nation’s nonprofit organ procurement organizations (OPOs) could be decertified and dissolved in 2026.
  • CMS has yet to offer guidance to OPOs on the realistic implementation of this rule without interrupting patient care.
  • OPOs are drivers of innovation in the nation’s organ donation and transplant system.
  • Despite its strength, the organ donation and transplantation system AOPO has made strides in improving is at risk of being destabilized and dismantled.

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.

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.

Optinose to Present at the 35th Annual Piper Sandler Healthcare Conference

Retrieved on: 
Wednesday, November 22, 2023

YARDLEY, Pa., Nov. 22, 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 members of its management team will present a company overview and business update at the 35th Annual Piper Sandler Healthcare Conference on November 29, 2023, at 3:30 p.m.

Key Points: 
  • YARDLEY, Pa., Nov. 22, 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 members of its management team will present a company overview and business update at the 35th Annual Piper Sandler Healthcare Conference on November 29, 2023, at 3:30 p.m.
  • ET.
  • To listen to a webcast of the presentation live, please visit the Investors page of the Optinose website.
  • A replay of the webcast will be available for 60 days following the conclusion of the event.