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Lead Product(s): TransCon hGH
Therapeutic Area: Endocrinology Product Name: ACP-001
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 September 23, 2020
Details:
Ascendis has filed a Clinical Trial Notification with the Pharmaceuticals and Medical Devices Agency in Japan to start company’s phase 3 riGHt Trial of TransCon™ hGH (lonapegsomatropin), a long-acting prodrug of somatropin, to treat pediatric growth hormone deficiency.
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Lead Product(s): Insulin icodec
Therapeutic Area: Endocrinology 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 September 22, 2020
Details:
The first showed that switching to insulin icodec from other basal insulins using two different switch approaches was efficacious and well-tolerated compared to once-daily insulin glargine U100.
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Lead Product(s): TransCon hGH
Therapeutic Area: Endocrinology Product Name: ACP-001
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 September 08, 2020
Details:
This MAA submission, which follows the approval of our Paediatric Investigation Plan (PIP) from EMA, is an important next step for extending the global reach of TransCon hGH.
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Lead Product(s): TransCon hGH
Therapeutic Area: Endocrinology Product Name: ACP-001
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 August 27, 2020
Details:
New data from the four-week, fixed dose, double-blind portion of PaTH Forward demonstrated statistically significant and clinically meaningful improvements in SF-36 functional health and well being outcomes.
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Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
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 July 06, 2020
Details:
Paediatric Committee of the European Medicines Agency supports the investigation of TransCon hGH for treatment of growth hormone deficiency in the pediatric population from 6 months to less than 18 years of age.
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Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
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 June 26, 2020
Details:
TransCon hGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin.
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Lead Product(s): Dasiglucagon
Therapeutic Area: Endocrinology Product Name: HypoPal
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 June 14, 2020
Details:
The dasiglucagon HypoPal® rescue pen is under FDA review as a potential fast and effective treatment of severe hypoglycemia in diabetes.
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Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology 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 June 08, 2020
Details:
The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch to TransCon hGH, an investigational long-acting prodrug that releases somatropin, with consistent and predictable efficacy.
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Lead Product(s): Dasiglucagon
Therapeutic Area: Endocrinology Product Name: Undisclosed
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 May 22, 2020
Details:
The dasiglucagon HypoPal® rescue pen New Drug Application represents a major milestone in Zealand Pharma’s efforts to bring life changing therapies to people with diabetes.
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Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology 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 April 15, 2020
Details:
FDA has granted Orphan Drug Designation to TransCon hGH, as a treatment for growth hormone deficiency. There is no approved long-acting growth hormone treatment on the market in the U.S. or Europe.
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