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Lead Product(s): TransCon hGH
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 October 21, 2020
Details:
Data from the phase 3 fliGHt Trial of TransCon hGH (lonapegsomatropin) in pediatric growth hormone deficiency (GHD) and from two clinical trials of the auto-injector for lonapegsomatropin will be presented at the Pediatric Endocrinology Nursing Society national conference.
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Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
Results from the previously completed dose validation ("DV") study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.
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Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
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 30, 2020
Details:
Teplizumab is an anti-CD3 monoclonal antibody (mAb) being developed for the interception, delay, or prevention of type 1 diabetes (T1D).
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Lead Product(s): Imeglimin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
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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): Levoketoconazole
Therapeutic Area: Endocrinology Product Name: Recorlev
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering September 16, 2020
Details:
The Company intends to use the net proceeds to continue development and regulatory activities, facilitate commercial readiness and commercially launch Recorlev primarily in the US, support the life cycle management activities of Keveyis and for general corporate purposes.
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Lead Product(s): GAD-alum
Therapeutic Area: Endocrinology Product Name: Diamyd
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 14, 2020
Details:
In line with previous large-scale analysis of trials involving subcutaneous administration of Diamyd®, the reults, encompassing a total of 109 patients, showed a statistically significant effect in the predefined HLA (Human Leukocyte Antigen) subgroup of trial participants.
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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): GAD-alum
Therapeutic Area: Endocrinology Product Name: Diamyd
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 01, 2020
Details:
The analysis while not reaching statistical significance, supports a positive effect of subcutaneous injections of Diamyd® on delaying the progression to type 1 diabetes in HLA-type DR3-DQ2 group while no benefit vs placebo is seen in individuals negative for HLA-type DR3-DQ2.
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