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Theravance Biopharma
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Yupelri (revefenacin) is a novel small molecule, M3 receptor inhibitor. It is under phase 4 clinical studies in patients with severe to very severe chronic obstructive pulmonary disease (COPD).


Lead Product(s): Revefenacin

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Yupelri

Highest Development Status: Phase IVProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2024

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TD-9855 (ampreloxetine) is an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).


Lead Product(s): Ampreloxetine

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TD-9855

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2023

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Ampreloxetine (TD-9855) is an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic nOH in patients with multiple system atrophy (MSA).


Lead Product(s): Ampreloxetine

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TD-9855

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2022

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Ampreloxetine (TD-9855) is an investigational, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).


Lead Product(s): Ampreloxetine

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TD-9855

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2022

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The Company now anticipates it will approach breakeven cash flow in the second half of 2022 without the cash flows from its interest in GSK's Trelegy Ellipta (fluticasone furoate) royalties, driven by disciplined spending within R&D and the growth of YUPELRI®.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trelegy Ellipta

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Royalty Pharma

Deal Size: $1,550.0 million Upfront Cash: $1,100.0 million

Deal Type: Divestment July 13, 2022

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Primary endpoint for ampreloxetine, an norepinephrine reuptake inhibitor was not statistically significant for overall population of patients which included patients with Parkinson's disease, pure autonomic failure and MSA.


Lead Product(s): Ampreloxetine

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TD-9855

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 04, 2022

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Enrollment of first patient in the Phase 4 PIFR-2 for YUPELRI® (revefenacin) is on the basis of continued investment in controlled clinical studies, that design to personalized treatment plans in order to make better-informed decisions for their COPD patients.


Lead Product(s): Revefenacin

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Yupelri

Highest Development Status: Phase IVProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 10, 2022

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Nezulcitinib is an investigational, inhaled, lung-selective, pan-Janus kinase (JAK) inhibitor in development for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.


Lead Product(s): Nezulcitinib

Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: TD-0903

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 21, 2021

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First COVID-19 patient has been dosed in a Phase 2 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19.


Lead Product(s): Nezulcitinib

Therapeutic Area: Infections and Infectious Diseases Product Name: TD-0903

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 25, 2020

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Theravance Biopharma received approval of TD-0903's initial Clinical Trial Application (CTA) in the United Kingdom (UK) for the Phase 1 study.


Lead Product(s): Nezulcitinib

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

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