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1020 Stony Hill Road, Suite 300 Yardley, Pennsylvania 19067
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Details:

Xhance (fluticasone propionate) is a drug-device combination product, which is approved for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Infections and Infectious Diseases Product Name: Xhance

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 15, 2024

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Xhance (fluticasone propionate) is a glucocorticoid receptor agonist, steroid drug candidate administered via intranasal spray for the treatment of chronic rhinosinusitis.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2023

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Xhance (fluticasone propionate) is a drug-device combination product that uses the Exhalation Delivery System designed to deliver a topical anti-inflammatory to the high and deep regions of the nasal cavity where sinuses ventilate and drain.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xhance

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2023

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Xhance is a drug-device combination with fluticasone propionate which is a synthetic trifluorinated corticosteroid which exhibits great binding affinity for the human glucocorticoid receptor and shows anti-inflammatory activity.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 21, 2023

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Optinose intends to use the net proceeds of the offering for working capital and general corporate purposes, including the commercialization of XHANCE, and the pursuit of a follow-on indication for XHANCE for the treatment of chronic sinusitis.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Piper Sandler

Deal Size: $50.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering November 21, 2022

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ReOpen2 was the second of two phase 3 clinical trials in its ReOpen Program which evaluated XHANCE, also referred to as the Exhalation Delivery System with fluticasone (EDS-FLU), as a potential treatment for chronic sinusitis.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 09, 2022

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XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product combining its proprietary Exhalation Delivery System designed to uniquely deliver drug high and deep in nasal passages with an anti-inflammatory drug.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 08, 2022

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Details:

The safety profile and tolerability of Fluticasone Propionate in this trial were consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and common than the Exhalation Delivery System placebo group in this trial.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 13, 2022

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Details:

XHANCE® (fluticasone propionate), is a drug-device combination product that uses the Exhalation Delivery System met both co-primary endpoints in the ReOpen1 trial, demonstrating statistically significant benefits on symptoms and CT scans in patients with chronic sinusitis.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 07, 2022

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Details:

Optinose intends to use the net proceeds of the offering for the commercialization of XHANCE, the clinical development of XHANCE for a follow-on indication for the treatment of chronic sinusitis and other potential development programs.


Lead Product(s): Fluticasone Propionate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Piper Sandler

Deal Size: $46.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering November 18, 2021

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