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Ascendis Pharma

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Chinaplas 2020

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Ascendis Pharma A/S Receives Positive Opinion from the Paediatric Committee of the EMA on the Agreement of a Paediatric Investigation Plan

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.

Ascendis Pharma

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Chinaplas 2020

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Ascendis Pharma A/S Announces Submission of Biologics License Application for TransCon™ hGH in Pediatric Growth Hormone Deficiency

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.

Zealand Pharma

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Zealand Pharma Presents Clinical and Non-Clinical Evidence for Dasiglucagon Rescue Therapy

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.

Ascendis Pharma

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Ascendis Pharma A/S Announces Participation in ENDO Online 2020

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.

Zealand Pharma

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Zealand Pharma Announces FDA Acceptance of NDA for the Dasiglucagon Hypopal rescue Pen for Treatment of Severe Hypoglycemia

Lead Product(s): Dasiglucagon

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 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.

Ascendis Pharma

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Ascendis Pharma A/S Receives Orphan Drug Designation for TransCon™ hGH as Treatment for Growth Hormone Deficiency in the US

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.

Zealand Pharma

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Zealand Pharma announces positive topline results from Phase 2 trial with dasiglucagon

Lead Product(s): Dasiglucagon

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 March 30, 2020

Details:

Single mini-doses of dasiglucagon effectively reduced time spent in hypoglycemia after meals in individuals who have undergone bariatric surgery.

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Ascendis Pharma

Ascendis Pharma A/S Receives Positive Opinion from the Paediatric Committee of the EMA on the Agreement of a Paediatric Investigation Plan

Ascendis Pharma

Ascendis Pharma A/S Announces Submission of Biologics License Application for TransCon™ hGH in Pediatric Growth Hormone Deficiency

Zealand Pharma

Zealand Pharma Presents Clinical and Non-Clinical Evidence for Dasiglucagon Rescue Therapy

Ascendis Pharma

Ascendis Pharma A/S Announces Participation in ENDO Online 2020

Zealand Pharma

Zealand Pharma Announces FDA Acceptance of NDA for the Dasiglucagon Hypopal rescue Pen for Treatment of Severe Hypoglycemia

Ascendis Pharma

Ascendis Pharma A/S Receives Orphan Drug Designation for TransCon™ hGH as Treatment for Growth Hormone Deficiency in the US

Zealand Pharma

Zealand Pharma announces positive topline results from Phase 2 trial with dasiglucagon