CSBio CSBio

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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Areteia Therapeutics"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Reports Compelling Results From Phase 2 Trial With ExoFlo\u2122 in Hospitalized Patients With Respiratory Failure or Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Direct Biologics"},{"orgOrder":0,"company":"Regeneron Pharmaceuticals","sponsor":"Sanofi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dupixent\u00ae (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Regeneron Pharmaceuticals"},{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Insmed Completes Enrollment of Adult Patients in Phase 3 ASPEN Study of Brensocatib in Bronchiectasis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Insmed"},{"orgOrder":0,"company":"FibroGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FibroGen Announces Completion of Patient Enrollment in ZEPHYRUS-2, a Phase 3 Clinical Study of Pamrevlumab in Idiopathic Pulmonary Fibrosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"FibroGen"},{"orgOrder":0,"company":"BELLUS Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BELLUS Health Announces Positive Results from its Phase 1 Bioavailability Equivalence Study Evaluating Once-Daily Extended-Release Formulation of Camlipixant in Comparison to Twice-Daily Immediate Release Formulation","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"BELLUS Health"},{"orgOrder":0,"company":"Nuance Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nuance Pharma Announces Dosing of First Patient in ENHANCE - China Phase III Trial for Chronic Obstructive Pulmonary Disease (\"COPD\")","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Nuance Pharma"},{"orgOrder":0,"company":"Nuance Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nuance Pharma Announces Dosing of First Patient in ENHANCE China Phase 3 Trial for COPD","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Nuance Pharma"},{"orgOrder":0,"company":"BELLUS Health","sponsor":"GSK","pharmaFlowCategory":"D","amount":"$2,000.0 million","upfrontCash":"$2,000.0 million","newsHeadline":"GSK Reaches Agreement to Acquire Late-Stage Biopharmaceutical Company BELLUS Health","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"BELLUS Health"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Reports Compelling Data as ExoFlo\u2122 Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Direct Biologics"},{"orgOrder":0,"company":"Therapeutic Solutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Therapeutic Solutions"},{"orgOrder":0,"company":"FibroGen","sponsor":"Morgan Stanley Tactical Value","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"FibroGen Announces Non-Dilutive Term Loan Financing for up to $150 Million with Morgan Stanley Tactical Value","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"FibroGen"},{"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":"Small molecule","graph2":"Optinose"},{"orgOrder":0,"company":"Bellerophon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bellerophon Therapeutics Announces Last Patient Has Completed Blinded Treatment in Phase 3 REBUILD Study for INOpulse\u00ae in Fibrotic Interstitial Lung Disease","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Bellerophon Therapeutics"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Perceptive Advisors","pharmaFlowCategory":"D","amount":"$50 million","upfrontCash":"Undisclosed","newsHeadline":"Lyra Therapeutics Announces Closing of $50.0 Million Private Placement","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Bellerophon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bellerophon Announces Top-Line Data from Phase 3 REBUILD Clinical Trial of INOpulse\u00ae for Treatment of Fibrotic Interstitial Lung Disease","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Bellerophon Therapeutics"},{"orgOrder":0,"company":"Verona Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not 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Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Verona Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Verona Pharma"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Alvotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alvotech Enters into Exclusive 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Announces Additional $75MM in Series A Financing for Oral Dexpramipexole in Eosinophilic Asthma","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Areteia Therapeutics"}]

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            Dupixent (dupilumab), a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, reduced COPD exacerbations in Phase 3 trial.

            Lead Product(s): Dupilumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 27, 2023

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            TMF Summit 2024

            Not Confirmed

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            Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. Biophore has successfully developed aviptadil and is backward integrated with in-house API.

            Lead Product(s): Aviptadil Acetate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2021

            Details:

            Phase 3 trial showed Dupixent® (dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation.

            Lead Product(s): Dupilumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 17, 2021

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            TMF Summit 2024

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            The funding will be used to support the Phase III clinical development of dexpramipexole. It is an eosinophil maturation inhibitor that will be used in the treatment of Eosinophilic Asthma.

            Lead Product(s): Dexpramipexole

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: KNS-760704

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Viking Global Investors

            Deal Size: $425.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing February 13, 2024

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            The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.

            Lead Product(s): Levosimendan

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-103

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Roth Capital Partners

            Deal Size: $9.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering February 08, 2024

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            TNX-103 (levosimendan) is a potassium ATP channel activator and calcium sensitizer that affects the heart & vascular system. It is being evaluated in phase 3 trials for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).

            Lead Product(s): Levosimendan

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-103

            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 07, 2024

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            The proceeds will support Verona’s planned commercial launch of RPL554 (ensifentrine), Verona Pharma’s first-in-class product candidate, which is under review by the US FDA for the maintenance treatment of chronic obstructive pulmonary disease.

            Lead Product(s): Ensifentrine

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Oxford Finance

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing January 02, 2024

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            YUPELRI® (revefenacin) inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.

            Lead Product(s): Revefenacin

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Yupelri

            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 13, 2023

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            The combined company will more efficiently conduct clinical research and development of their promising pipeline of product candidates in organ fibrosis and inflammatory diseases, including F351 (hydronidone) for liver fibrosis.

            Lead Product(s): Hydronidone

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: F351

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Beijing Continent Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Merger October 30, 2023

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            BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness. Currently, there is only one therapy approved for the treatment of PPF.

            Lead Product(s): BMS-986278

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BMS-986278

            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 October 24, 2023

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