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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Ogluo
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Gvoke
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Megapharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 22, 2020
Details:
Megapharm will be responsible for registration and marketing of Gvoke in Israel and the Palestinian Authority, and named patient services supply. Xeris will manufacture, supply, and will take care of the quality assurance and control, regulatory support, and maintenance of IP.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Ogluo
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 11, 2020
Details:
The positive Opinion is based on the results from a Phase 3, multi-center, randomized controlled, non-inferiority study to evaluate the liquid stable glucagon auto-injector as a treatment for severe hypoglycemic events compared with Novo Nordisk’s GlucaGen® HypoKit®.
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Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: XP-0863
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
The FDA provided feedback that Xeris’ drug development program for XP-0863 could advance directly into a Phase 3 registration study in both pediatric and adult patients with epilepsy.
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Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: XP-0863
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
XP-0863 Phase 1b results and regulatory feedback support direct to Phase 3 registration study in both pediatric and adult patients with epilepsy.
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Lead Product(s): Pramlintide,Insulin
Therapeutic Area: Endocrinology Product Name: Xerisol
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
XP-3924 resulted in 62% reduction of hyperglycemia after a glucose challenge. XP-3924 showed promising glucose control when compared to both Humulin R and co-administered injections of Humulin R & Symlin and it showed improved glucose control when compared to Humulin R alone.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Gvoke RTU Micro
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Xeris Pharmaceuticals announced positive topline results of a Phase 2 study of its developmental Gvoke RTU Micro™ for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus who use insulin pumps.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase II 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:
Rebound hypoglycemia observed in the placebo arm with oral glucose tablet use; No rebound hypoglycemia observed in the RTU glucagon treatment arm.
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Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
Details:
Xeris’ IM diazepam maintains higher concentration over longer time period versus standard of care.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2020
Details:
Results show a mini dose (150 µg) of RTU glucagon prevents Exercise-Induced Hypoglycemia (EIH) during prolonged, moderate-to-high intensity aerobic exercise in a clinical research setting.
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