Active Filter(s):
Details:
The company is now working to complete all clinical and regulatory activities necessary to resume dosing and plans to have discussions at a future date with the regulators on the path forward toward global registration filings for AT132.
Lead Product(s): Resamirigene bilparvovec
Therapeutic Area: Genetic Disease Product Name: AT132
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 25, 2020
Details:
The application was based on the Phase 3 study interim analysis of study participants treated with investigational product manufactured by the to-be-commercialized process and three-year data from the Phase 1/2 Study.
Lead Product(s): Resamirigene bilparvovec
Therapeutic Area: Genetic Disease Product Name: AT132
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2020
Details:
Audentes is developing AT845, developed to recognise limitations of ERT by facilitating the intracellular production of GAA to improve efficacy, reduce immunogenicity, and deliver a durable and transformative clinical benefit from a single intravenous administration.
Lead Product(s): AT845
Therapeutic Area: Genetic Disease Product Name: AT845
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
Combined company establishes to become a global leader in AAV-based medicines, with Audentes to operate as a wholly-owned subsidiary and Center of Excellence for Astellas' newly created Genetic Regulation.
Lead Product(s): Resamirigene bilparvovec
Therapeutic Area: Genetic Disease Product Name: AT132
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $3,000.0 million Upfront Cash: $3,000.0 million
Deal Type: Acquisition January 15, 2020
Details:
Combined company establishes to become a global leader in AAV-based medicines, with Audentes to operate as a wholly-owned subsidiary and Center of Excellence for Astellas' newly created Genetic Regulation.
Lead Product(s): Resamirigene bilparvovec
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $3,000.0 million Upfront Cash: $3,000.0 million
Deal Type: Acquisition December 02, 2019