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Audentes Therapeutics
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Country
Country
U.S.A
Address
Address
600 California Street, 17th Floor San Francisco, CA 94108
Telephone
Telephone
(415) 818-1001

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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 IIProduct 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

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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 IIProduct 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

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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 IIProduct 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

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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 IIProduct 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

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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 IIProduct 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

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