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[{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascendis Pharma A\/S Receives Orphan Drug Designation for TransCon\u2122 hGH as Treatment for Growth Hormone Deficiency in the US","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascendis Pharma A\/S Announces Participation in ENDO Online 2020","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascendis Pharma A\/S Announces Submission of Biologics License Application for TransCon\u2122 hGH in Pediatric Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascendis Pharma A\/S Receives Positive Opinion from the Paediatric Committee of the EMA on the Agreement of a Paediatric Investigation 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            Details:

            Skytrofa (lonapegsomatropin) is designed to deliver unmodified somatropin, which is used for treatment of children and adolescents with growth failure due to insufficient endogenous growth hormone secretion. Its BLA has been accepted in China.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: Skytrofa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 07, 2024

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            Vector will employ its sales and marketing expertise to distribute both Skytrofa (lonapegsomatropin-tcgd) and Yorvipath in the GCC countries for pediatric growth hormone deficiency in the case of Skytrofa, and adult hypoparathyroidism in the case of Yorvipath.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: Skytrofa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Ascendis Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 08, 2024

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            Specialised Therapeutics will commercialise Ascendis' weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide).

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: Skytrofa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Ascendis Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 07, 2024

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            TransCon hGH (lonapegsomatropin) is a once-weekly growth hormone, is designed to deliver unmodified somatropin. which is being evaluated in phase 3 clinical trials for the treatment of growth hormone deficiency.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 19, 2023

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            Under the agreement, Teijin will receive exclusive license to further develop and commercialize TransCon hGH (lonapegsomatropin-tcgd), TransCon PTH, and TransCon CNP for endocrinology rare disease, in Japan.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Teijin Pharma

            Deal Size: $245.0 million Upfront Cash: $70.0 million

            Deal Type: Licensing Agreement November 29, 2023

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            ACP-011 (lonapegsomatropin), a long-acting prodrug of unmodified somatropin is being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: ACP-011

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Ascendis Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2022

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            Details:

            Top-line results of TransCon hGH, from the trial indicate that lonapegsomatropin was well-tolerated and with comparable safety to daily growth hormone. The safety profile of lonapegsomatropin in Chinese children with GHD was consistent.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 23, 2022

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            Details:

            VISEN’s Phase 3 Trial achieved primary endpoint; pediatric growth hormone deficiency (GHD) patients treated with TransCon hGH (lonapegsomatropin) demonstrated greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone.

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 23, 2022

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            Data from Week 130 of enliGHten trial reporting consistent long-term safety and sustained growth in pediatric growth hormone-deficient patients treated for 2.5 years with TransCon hGH (lonapegsomatropin).

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 01, 2022

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            Details:

            Ascendis Pharma intends to use the net proceeds to support the commercialization and further development of TransCon hGH, to fund pre-commercialization activities and clinical development of TransCon PTH, clinical development of its other endocrinology rare disease programs

            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $500.0 million Upfront Cash: Undisclosed

            Deal Type: Financing March 24, 2022

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