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    [{"orgOrder":0,"company":"Apic Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apic Bio gets FDA Fast Track Designation for APB-102 for Patients with SOD1 ALS","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Apic Bio","sponsor":"Uniqure","pharmaFlowCategory":"D","amount":"$55.0 million","upfrontCash":"$10.0 million","newsHeadline":"uniQure and Apic Bio Enter Into Global Licensing Agreement For APB-102, a Clinical Stage Gene Therapy for Patients With ALS Caused by Mutations in SOD1","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"}]

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              uniQure and Apic Bio Enter Into Global Licensing Agreement For APB-102, a Clinical Stage Gene Therapy for Patients With ALS Caused by Mutations in SOD1

              Details:

              Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders.

              Lead Product(s): APB-102

              Therapeutic Area: Neurology Product Name: APB-102

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Uniqure

              Deal Size: $55.0 million Upfront Cash: $10.0 million

              Deal Type: Licensing Agreement January 31, 2023

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              Apic Bio

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              Apic Bio gets FDA Fast Track Designation for APB-102 for Patients with SOD1 ALS

              Details:

              The Phase 1/2 clinical trial is a multi-center, three-part study to evaluate the safety, tolerability, and efficacy of intrathecally administered APB-102 in patients with SOD1 ALS mutations.

              Lead Product(s): APB-102

              Therapeutic Area: Neurology Product Name: APB-102

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 28, 2021

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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