Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Ascendis Submits BLA To FDA For TransCon™ hGH For Growth Hormone Deficiency
Details : Skytrofa (lonapegsomatropin) is a once-weekly growth hormone, is designed to deliver unmodified somatropin. Being evaluated for growth hormone deficiency in adults.
Brand Name : Skytrofa
Molecule Type : Peptide
Upfront Cash : Not Applicable
September 30, 2024
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
VISEN's Biologics License Application for Lonapegsomatropin Accepted in China
Details : Skytrofa (lonapegsomatropin) delivers unmodified somatropin for treating children with growth failure due to insufficient growth hormone, with its BLA accepted in China.
Brand Name : Skytrofa
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 07, 2024
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Ascendis Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Vector Pharma Signs Distribution Agreement for Skytrofa and Yorvipath
Details : Vector will distribute Skytrofa (lonapegsomatropin-tcgd) for pediatric growth hormone deficiency and Yorvipath for adult hypoparathyroidism in the GCC countries, using its sales expertise.
Brand Name : Skytrofa
Molecule Type : Large molecule
Upfront Cash : Undisclosed
January 08, 2024
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Ascendis Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Ascendis Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Specialised Therapeutics Signs Agreement for Three Endocrinology Therapies
Details : Specialised Therapeutics will commercialize Ascendis' injectable pediatric growth hormone SKYTROFA, hypoparathyroidism treatment YORVIPATH, and investigational therapy TransCon CNP.
Brand Name : Skytrofa
Molecule Type : Large molecule
Upfront Cash : Undisclosed
January 07, 2024
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Ascendis Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : TransCon hGH
Molecule Type : Peptide
Upfront Cash : Not Applicable
December 19, 2023
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Teijin Pharma
Deal Size : $245.0 million
Deal Type : Licensing Agreement
Ascendis Pharma Announces Strategic Partnership with Teijin Limited in Japan
Details : 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.
Brand Name : TransCon hGH
Molecule Type : Large molecule
Upfront Cash : $70.0 million
November 29, 2023
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Teijin Pharma
Deal Size : $245.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Ascendis Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
VISEN Discloses 52-week Clinical Results for Its China Phase 3 Trial of Lonapegsomatropin
Details : 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.
Brand Name : ACP-011
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 17, 2022
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Ascendis Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : TransCon hGH
Molecule Type : Peptide
Upfront Cash : Not Applicable
May 23, 2022
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 d...
Brand Name : TransCon hGH
Molecule Type : Peptide
Upfront Cash : Not Applicable
May 23, 2022
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Ascendis Pharma A/S to Present New Endocrinology Results at Four Medical Meetings in May
Details : 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).
Brand Name : TransCon hGH
Molecule Type : Peptide
Upfront Cash : Not Applicable
May 01, 2022
Lead Product(s) : Lonapegsomatropin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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