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Lead Product(s): Cerebral Dopamine Neurotrophic Factor
Therapeutic Area: Neurology Product Name: CDNF
Highest Development Status: Phase I/ Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Nanoform
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 09, 2021
Details:
Nanoform and Herantis have reached an agreement for formulation Proof of Concept projects (PoCs) aiming to enhance nasal drug delivery to the brain of Herantis’ CDNF therapies for Parkinson’s disease using Nanoform’s proprietary biological nanoparticle technology.
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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): Human astrocytes
Therapeutic Area: Neurology Product Name: AstroRx
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 15, 2020
Details:
The primary objective of the trial was to evaluate the safety of AstroRx®, an "off-the-shelf", clinical-grade, astrocyte cell product, developed and manufactured by the Company. The trial met its endpoints.
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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 cannabinoid based 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.