Pulmonary/Respiratory Diseases | Phase II Developments | UNITED STATES

Acceleron Pharma

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Acceleron Announces Pricing of Public Offering of Common Stock

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.

Acceleron Pharma

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Acceleron Announces Proposed Public Offering of Common Stock

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.

Windtree Therapeutics

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Windtree Announces Initial European Trial Sites Activated in AEROSURF®

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.

Acceleron Pharma

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Acceleron to Host Conference Call and Webcast to Review Results of PULSAR Phase 2 Trial of Sotatercept

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.

Veru

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Veru Enrolls First Patient in Phase 2 Clinical Trial of Novel Drug, VERU-111, to Combat COVID-19

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.

Insmed

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Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)

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.

Partner Therapeutics

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Partner Therapeutics Announces Start of Clinical Trial to Evaluate Leukine in Respiratory Illness in Patients with COVID-19

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.

Aerpio Pharmaceuticals

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Aerpio Pharmaceuticals and Quantum Leap Healthcare Collaborative Announce the Selection of Razuprotafib for I-SPY COVID Trial

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.

Insmed Inc

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Insmed to Showcase New Brensocatib Data at American Thoracic Society Virtual Clinical Trials Session

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 May 20, 2020

Details:

New data from the Phase 2 WILLOW study of brensocatib (formerly known as INS1007) in non-cystic fibrosis bronchiectasis (NCFBE) will be presented during a virtual clinical trials session hosted by the American Thoracic Society (ATS).

Gossamer Bio

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Gossamer Bio Announces Proposed Concurrent Public Offerings of Common Stock and Convertible Senior Notes Due 2027

Lead Product(s): GB001

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering May 18, 2020

Details:

Gossamer intends to use the combined net proceeds of the offerings to fund research and development of its product candidates and development programs and for working capital and general corporate purposes.

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Acceleron Pharma

Acceleron Announces Pricing of Public Offering of Common Stock

Acceleron Pharma

Acceleron Announces Proposed Public Offering of Common Stock

Windtree Therapeutics

Windtree Announces Initial European Trial Sites Activated in AEROSURF®

Acceleron Pharma

Acceleron to Host Conference Call and Webcast to Review Results of PULSAR Phase 2 Trial of Sotatercept

Veru

Veru Enrolls First Patient in Phase 2 Clinical Trial of Novel Drug, VERU-111, to Combat COVID-19

Insmed

Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)

Partner Therapeutics

Partner Therapeutics Announces Start of Clinical Trial to Evaluate Leukine in Respiratory Illness in Patients with COVID-19

Aerpio Pharmaceuticals

Aerpio Pharmaceuticals and Quantum Leap Healthcare Collaborative Announce the Selection of Razuprotafib for I-SPY COVID Trial

Insmed Inc

Insmed to Showcase New Brensocatib Data at American Thoracic Society Virtual Clinical Trials Session

Gossamer Bio

Gossamer Bio Announces Proposed Concurrent Public Offerings of Common Stock and Convertible Senior Notes Due 2027