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Find Neurology Drugs in Phase I/II Clinical Development in UNITED STATES

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            Lead Product(s): PR001,Methylprednisolone,Sirolimus

            Therapeutic Area: Neurology Product Name: PR001

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: $1,040.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition December 15, 2020

            Details:

            Acquisition will establish a gene therapy program at Lilly, anchored by Prevail's portfolio of neuroscience assets, and will broaden Lilly's commitment to use novel modalities to attempt to address otherwise fatal genetic forms of neurodegenerative disease.

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            Lead Product(s): BOL-DP-o-04

            Therapeutic Area: Neurology Product Name: BOL-DP-o-04

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: BOL Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement December 01, 2020

            Details:

            Under the agreement, Kindeva will develop novel formulations of BOL Pharma’s cannabinoidbased drug products delivered by Kindeva’s metered-dose inhaler (MDI) technology.

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            Lead Product(s): PR006,Methylprednisolone,Sirolimus

            Therapeutic Area: Neurology Product Name: PR006

            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 November 30, 2020

            Details:

            PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations.

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            Lead Product(s): PR001,Methylprednisolone,Sirolimus

            Therapeutic Area: Neurology Product Name: PR001

            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 November 18, 2020

            Details:

            The Company expects to initiate enrollment of the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease patients in the fourth quarter of 2020 and currently anticipates it will provide the next update on PR001 biomarker and safety data for nGD in 2021.

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            Lead Product(s): PR001,Methylprednisolone,Sirolimus

            Therapeutic Area: Neurology Product Name: PR001

            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 October 27, 2020

            Details:

            The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD). Prevail expects to start enrollment of the PROVIDE Phase 1/2 clinical trial of PR001 in the second half of 2020.

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            Lead Product(s): ION541

            Therapeutic Area: Neurology Product Name: BIIB105

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

            Details:

            Veklury stops replication of sars-co v-2,thee virus that causes covid-19. Previously authorized bytheefdaa for emergency use to treat covid-19, Veklury is now the first and only approved covid-19 treatment in the united states.

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            Lead Product(s): STK-001

            Therapeutic Area: Neurology Product Name: STK-001

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

            Details:

            Following recent interactions with the U.S. FDA related to the partial clinical hold on higher dose levels in the MONARCH study, the FDA will allow the Company to add an additional higher dose level to the single ascending dose portion of the study assessing STK-001.

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            Lead Product(s): STK-001

            Therapeutic Area: Neurology Product Name: STK-001

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 26, 2020

            Details:

            Data published in the journal Science Translational Medicine showed that STK-001 achieved target engagement, pharmacologic activity and efficacy by selectively increasing Scn1a gene and Nav1.1 protein expression.

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            Lead Product(s): PR006

            Therapeutic Area: Neurology Product Name: PR006

            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 July 27, 2020

            Details:

            PR006 is being developed as a potential one-time gene therapy for FTD-GRN, a progressive neurodegenerative disease caused by mutations in the GRN gene that reduce production of progranulin.

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            Lead Product(s): AXO-Lenti-PD

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 June 15, 2020

            Details:

            A Phase 1/2 clinical trial testing AXO-Lenti-PD (OXB102), Axovant‘s experimental gene therapy for Parkinson’s disease, has completed dosing of all four adults in a second group in its dose-escalation part of the study.