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Pegzilarginase","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aeglea Completes Patient Randomization for its Pivotal Phase 3 Clinical Trial of Pegzilarginase for the Treatment of Arginase 1 Deficiency","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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III"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aeglea BioTherapeutics Announces Presentation of Additional Data from PEACE Phase 3 Study of Pegzilarginase for the Treatment of Arginase 1 Deficiency at the Society for Inherited Metabolic Disorders Annual Meeting","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aeglea BioTherapeutics Announces European Medicines Agency Validation of Marketing Authorization Application for Pegzilarginase for the Treatment of Arginase 1 Deficiency","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aeglea BioTherapeutics Announces Interim Results from Ongoing Phase 1\/2 Clinical Trial of Pegtarviliase for the Treatment of Classical Homocystinuria and Begins Process to Explore Strategic Alternatives","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Aeglea BioTherapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Aeglea BioTherapeutics Announces Acquisition of Spyre Therapeutics","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Preclinical"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Fairmount Funds Management","pharmaFlowCategory":"D","amount":"$210.0 million","upfrontCash":"Undisclosed","newsHeadline":"Aeglea BioTherapeutics Announces Acquisition of Spyre Therapeutics","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Preclinical"},{"orgOrder":0,"company":"Aeglea BioTherapeutics","sponsor":"Immedica Pharma","pharmaFlowCategory":"D","amount":"$115.0 million","upfrontCash":"$15.0 million","newsHeadline":"Aeglea BioTherapeutics Announces Sale of Pegzilarginase to Immedica Pharma","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"}]

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            Details:

            Under the agreement, Immedica gains global rights of AEB1102 (pegzilarginase), a novel recombinant human enzyme engineered to degrade the amino acid arginine, for the treatment of rare metabolic disease Arginase 1 Deficiency.

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: AEB1102

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Immedica Pharma

            Deal Size: $115.0 million Upfront Cash: $15.0 million

            Deal Type: Agreement July 27, 2023

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            Through the acquisition, Aeglea expands its inflammatory bowel disease portfolio by including, SPY001 and SPY002, that are potentially best-in-class antibodies targeting a 4 b 7 and TL1A, respectively.

            Lead Product(s): SPY001

            Therapeutic Area: Gastroenterology Product Name: SPY001

            Highest Development Status: Preclinical Product Type: Large molecule

            Recipient: Spyre Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition June 22, 2023

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            The company intends to use the net proceeds in advancing a leading inflammatory bowel disease (IBD) portfolio including, SPY001 and SPY002, that are potentially best-in-class antibodies targeting a 4 b 7 and TL1A, respectively.

            Lead Product(s): SPY001

            Therapeutic Area: Gastroenterology Product Name: SPY001

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Fairmount Funds Management

            Deal Size: $210.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement June 22, 2023

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            ACN00177 (pegtarviliase) is a novel recombinant human enzyme engineered to reduce elevated levels of total homocysteine, for the treatment of classical homocystinuria.

            Lead Product(s): Pegtarviliase

            Therapeutic Area: Genetic Disease Product Name: ACN00177

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 12, 2023

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            AEB1102 (pegzilarginase) is a novel, recombinant human arginase 1 enzyme that in clinical trials has been shown to normalize the elevated levels of the amino acid arginine in patients with ARG1-D, a rare, progressive disease characterized by high levels of arginine.

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: AEB1102

            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 August 18, 2022

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            Details:

            In PEACE Phase 3 clinical trial, treatment with pegzilarginase was shown to markedly reduce blood arginine levels in patients with ARG1-D, also has received several regulatory designations from the U.S.FDA as well as Orphan drug designation from the EMA.

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: AEB1102

            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 March 29, 2022

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            Pegzilarginase met its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment is a First potential therapy to address key driver of ARG1-D, a devastating ultra-rare disease.

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            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 06, 2021

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            Details:

            Result showed Phase 3 study, PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment.

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            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 05, 2021

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            Aeglea BioTherapeutics has completed patient randomization for PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), the pivotal Phase 3 clinical trial investigating pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D).

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            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 May 03, 2021

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            Details:

            Aeglea BioTherapeutics will supply pegzilarginase, a novel, recombinant human arginase 1 enzyme that has been shown to lower toxic levels of the amino acid arginine in patients with Arginase 1 Deficiency (ARG1-D).

            Lead Product(s): Pegzilarginase

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Immedica

            Deal Size: $151.5 million Upfront Cash: $21.5 million

            Deal Type: Licensing Agreement March 22, 2021

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