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            Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

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            Lead Product(s): Ciclosporin

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            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 April 28, 2020

            Details:

            FDA has granted Fast Track designation to Liposomal Cyclosporine A for Inhalation (L‑CsA‑i), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome.

            Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

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            Lead Product(s): Ciclosporin

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            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 20, 2020

            Details:

            Liposomal Cyclosporine A for Inhalation (L?CsA?i) is advancing in clinical studies for the treatment for bronchiolitis obliterans syndrome.

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            Lead Product(s): Pirfenidone

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Esbriet

            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 January 21, 2021

            Details:

            US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).

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            Lead Product(s): Imatinib

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Tenax Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition January 19, 2021

            Details:

            The acquisition expands Tenax’s pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate. Imatinib is a tyrosine kinase inhibitor that transformed the treatment of cancer by blocking the underlying pathways resulting in long lasting remissions.

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            Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204

            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 January 06, 2021

            Details:

            RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S.

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            Lead Product(s): Tezepelumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AMG 157

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amgen Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 22, 2020

            Details:

            The 48-week trial did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 17, 2020

            Details:

            The DSMB noted that the trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment.

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            Lead Product(s): Sotatercept

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ACE-011

            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 December 14, 2020

            Details:

            Acceleron is currently advancing a Phase 3 development plan for sotatercept, beginning with the registrational trial known as STELLAR expected to initiate by the end of this year.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 02, 2020

            Details:

            Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year.