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[{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces Anti-COVID-19 Product Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Optinose","sponsor":"KALEO INC","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Optinose Announces XHANCE Co-Promotion Agreement with Kal\u00e9o","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Completes Patient Recruitment in Second Pivotal Trial for XHANCE in Chronic Sinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Piper Sandler","pharmaFlowCategory":"D","amount":"$46.0 million","upfrontCash":"Undisclosed","newsHeadline":"Optinose Announces Closing of $46.0 Million Public Offering of Common Stock","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Reports Positive Top-line Results in ReOpen1, a Landmark Phase 3 Trial for XHANCE in Chronic Sinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces Positive Top-line Results of ReOpen2, its second Phase 3 Clinical Trial of XHANCE for Treatment of Chronic Sinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces Additional Positive Results from ReOpen2 and Initial Results from Pooled Analyses of Both Trials in the ReOpen Program","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces ReOpen2 Presentation at the American College of Asthma, Allergy, and Immunology (ACAAI) 2022 Annual Scientific Meeting","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Optinose","sponsor":"Piper Sandler","pharmaFlowCategory":"D","amount":"$50.0 million","upfrontCash":"Undisclosed","newsHeadline":"Optinose Announces Pricing of Public Offering of Common Stock and Warrants","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Submits Supplemental New Drug Application for XHANCE Label Expansion","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"}]

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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: Approved Product 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 III Product 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 III Product 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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            Details:

            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 III Product 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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            Details:

            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: Approved Product 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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            Details:

            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 III Product 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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            Details:

            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: Approved Product 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: Approved Product 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: Approved Product 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 III Product 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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