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Find Drugs for Pulmonary/Respiratory Diseases in Phase II Clinical Development

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            Lead Product(s): Sotatercept

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: $450.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 30, 2020

            Details:

            Acceleron intends to use the net proceeds to conduct clinical trials and associated activities in connection with its therapeutic candidates in its pulmonary programs, to prepare for the potential launch and commercialization of sotatercept and the remainder for general corporate purposes.

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            Lead Product(s): Sotatercept

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Public Offering June 29, 2020

            Details:

            Acceleron intends to use the net proceeds from the offering to conduct clinical trials and associated activities in connection with its therapeutic candidates in its pulmonary programs; to prepare for the potential launch and commercialization of sotatercept.

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            Lead Product(s): Lucinactant

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Aerosurf

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 24, 2020

            Details:

            The AEROSURF Phase 2b bridging study is a multicenter, randomized, controlled study with masked treatment assignment in up to 90 premature infants 26 to 32 weeks gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for RDS.

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            Lead Product(s): Sotatercept

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2020

            Details:

            Conference call and webcast will review the topline results of the PULSAR Phase 2 trial of sotatercept in patients with pulmonary arterial hypertension (PAH). Data from the PULSAR trial will have been presented during a virtual session of the American Thoracic Society 2020.

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            Lead Product(s): VERU-111

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: VERU-111

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 19, 2020

            Details:

            Veru has enrolled the first patient in its Phase 2 clinical trial of VERU-111, a novel microtubule depolymerization drug to combat COVID-19, the global pandemic disease caused by the coronavirus SARS-CoV-2.

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            Lead Product(s): Brensocatib

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

            Details:

            FDA has granted breakthrough therapy designation to brensocatib for treating patients with NCFBE, recognizing the strength of data from Company's Phase 2 WILLOW study and the potential for brensocatib to offer a novel, first-in-class treatment approach to bronchiectasis.

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            Lead Product(s): LSALT peptide

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

            Details:

            The submission of the IND application was made by Arch following several weeks of review of the Company’s Phase II study for LSALT peptide in COVID-19 by the FDA under the Coronavirus Treatment Acceleration Program.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            The post-hoc analysis from a randomized, placebo-controlled Phase 2 trial in COPD showed that remestemcel-L significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP).

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            Lead Product(s): Sargramostim

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

            Details:

            Company to initiate an investigator-initiated randomized, double-blind, placebo-controlled clinical trial of Leukine(sargramostim, rhu-GM-CSF) in patients with acute respiratory failure associated with COVID-19, conducted at Singapore General Hospital.

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            Lead Product(s): Razuprotafib

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Quantum Leap Healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration May 27, 2020

            Details:

            The collaboration aims at evaluating razuprotafib in a new randomized, investigational treatment arm in the I-SPY COVID Trial for the treatment of acute respiratory distress syndrome (ARDS) in adult patients with moderate to severe COVID-19.

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