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    [{"orgOrder":0,"company":"Spero Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spero Completes Patient Enrollment in Pivotal Phase 3 Clinical Trial of Oral Tebipenem HBr vs Intravenous Ertapenem for Complicated UTI","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Spero Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spero Therapeutics Announces Topline Results from its Phase 3 ADAPT-PO Trial of Tebipenem HBr in Complicated UTI and Acute Pyelonephritis","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase 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PIVOT-PO Trial of Tebipenem HBr","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Spero Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spero Therapeutics Announces First Patient, First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]

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              Spero Therapeutics

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              Spero Therapeutics Announces First Patient, First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections

              Details:

              SPR994 (tebipenem pivoxil hydrobromide) is an oral antibiotic which is under phase 3 clinical development for the treatment of patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 02, 2024

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              Spero Therapeutics

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              Spero Therapeutics Announces Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr

              Details:

              SPR994 is Spero’s novel late-stage development asset, an oral formulation tablet of tebipenem pivoxil hydrobromide, a carbapenem antibiotic of the β-lactam class.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 July 31, 2023

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              Spero Therapeutics

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              Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr

              Details:

              Under the terms of the agreement, Spero is responsible for the execution and costs of Phase 3 trial of tebipenem HBr (tebipenem pivoxil hydrobromide), an investigational drug, is being developed as the potentially first oral carbapenem antibiotic for the treatment of cUTI.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: Tebipenem HBr

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: GSK

              Deal Size: $591.0 million Upfront Cash: $66.0 million

              Deal Type: Licensing Agreement November 08, 2022

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              Spero Therapeutics

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              GSK and Spero Therapeutics Announce Exclusive Licence Agreement for Tebipenem HBr, a Late-Stage Antibiotic that May Treat Complicated Urinary Tract Infections

              Details:

              Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialisation.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: GSK

              Deal Size: $816.0 million Upfront Cash: $66.0 million

              Deal Type: Licensing Agreement September 22, 2022

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              Spero Therapeutics

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              Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting with the U.S. Food and Drug Administration

              Details:

              FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of SPR994 (tebipenem HBr).

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 September 06, 2022

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              Spero Therapeutics

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              Spero Therapeutics Submits New Drug Application to U.S. FDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

              Details:

              Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 28, 2021

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              Spero Therapeutics

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              Spero Therapeutics Enters Into a Non-Dilutive Revenue Interest Financing Agreement With HealthCare Royalty Partners® for Up to $125 Million

              Details:

              Spero intends to use the proceeds from the agreement for launch of tebipenem HBr, for a complicated urinary tract infection (cUTI) indication as well as to support the continued clinical development of SPR720 and SPR206.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: HealthCare Royalty Partners

              Deal Size: $125.0 million Upfront Cash: Undisclosed

              Deal Type: Financing September 30, 2021

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              Spero Therapeutics

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              Spero Therapeutics to Present Data at IDWeek 2021

              Details:

              Presentations will showcase in vitro and in vivo studies of tebipenem HBr for treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) and highlight additional research on the epidemiology and management of cUTI.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 September 16, 2021

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              Spero Therapeutics

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              Spero Therapeutics Announces Topline Results from its Phase 3 ADAPT-PO Trial of Tebipenem HBr in Complicated UTI and Acute Pyelonephritis

              Details:

              Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis.

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994

              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 September 08, 2020

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              Spero Therapeutics

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              Spero Completes Patient Enrollment in Pivotal Phase 3 Clinical Trial of Oral Tebipenem HBr vs Intravenous Ertapenem for Complicated UTI

              Details:

              Phase 3 clinical trial, ADAPT-PO, is evaluating tebipenem HBr for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).

              Lead Product(s): Tebipenem Pivoxil Hydrobromide

              Therapeutic Area: Infections and Infectious 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 May 05, 2020

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