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Find FDA Investigational New Drug (IND) Submissions for Neurology

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.