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    Find FDA Investigational New Drug (IND) Submissions for Neurology

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              AgeX Therapeutics

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared IND for IMS001

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              Lead Product(s): IMS001

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 20, 2020

              Details:

              ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

              Prevail Therapeutics

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Prevail Announces Investigational New Drug Application Active for PR006

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              Lead Product(s): PR006

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 02, 2020

              Details:

              The PROCLAIM Phase 1/2 clinical trial will investigate the safety and tolerability of PR006, and will also measure key biomarkers and exploratory efficacy endpoints in patients with FTD-GRN.

              ProMIS Neurosciences

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              ProMIS Neurosciences Initiates Natural History Study of Blood-Based Biomarkers in Alzheimer’s Disease

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              Lead Product(s): PMN310

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 26, 2020

              Details:

              Biomarkers offer opportunity to make go/no-go decisions for investigational therapies as early as Phase 1.

              Antibe Therapeutics

              • Development Update

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              CANADA Canada

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              Drug Discovery Chemistry

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              Antibe Therapeutics Announces Research Publication Showing Markedly Enhanced Pain Relief of Second Pipeline Drug

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              Lead Product(s): ATB-352

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 24, 2020

              Details:

              The article reports on a series of studies which demonstrate that ATB-352 induces much greater pain relief than ketoprofen in a well characterized animal model of surgical pain.

              Retrotope

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

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              Lead Product(s): Linoleic Acid

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 18, 2020

              Details:

              The company stated that, RT001 has a synergistic downstream benefit in the pathophysiology of PSP. This orphan designation encourages clinical trials and rapid review of data from trials to treat PSP.

              EuMentis Therapeutics

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              EuMentis Therapeutics Inc to Focus on Developing New Therapy to Treat High Value Neurodevelopmental and Neurodegenerative Diseases

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              Lead Product(s): EM-036

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 13, 2020

              Details:

              EM-036 has demonstrated superior efficacy in preclinical Alzheimer's disease and autism spectrum disorders models compared to current standard of care.

              ReAlta Life Sciences

              • Development Update

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              UNITED KINGDOM United Kingdom

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              Drug Discovery Chemistry

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              ReAlta Life Sciences Announces FDA Orphan Drug Designation for PIC1

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              Lead Product(s): PIC1-dPEG24

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 06, 2020

              Details:

              PIC1 positioned as a novel pharmacological intervention to improve survival and cognitive outcomes for newborns affected by devastating disease.

              Emerald Health Pharmaceuticals

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Emerald Health Pharmaceuticals Granted Orphan Designation in Europe for Huntington’s Disease

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              Lead Product(s): EHP-102

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 29, 2020

              Details:

              This EMA Orphan Designation to EHP-102 provides Emerald Health additional global advantages by recognizing the unmet need with Huntington’s Disease.

              Ra Pharmaceuticals

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Ra Pharmaceuticals Announces Clearance of IND Application for the HEALEY ALS Platform Trial

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              Lead Product(s): Zilucoplan

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 22, 2020

              Details:

              Zilucoplan was selected as one of the first clinical candidates to be evaluated in this platform trial for ALS led by the Sean M. Healey & AMG Center for ALS at Mass General.

              Polaryx Therapeutics

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Polaryx Therapeutics Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis

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              Lead Product(s): PLX-200

              Therapeutic Area: Neurology

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 20, 2020

              Details:

              This IND approval will allow Polaryx Therapeutics to advance PLX-200 clinical studies for LINCL patients.

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