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Find FDA Investigational New Drug (IND) Submissions for Neurology in UNITED STATES

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            Lead Product(s): Linoleic Acid

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 April 28, 2020

            Details:

            Retrotope filed this IND for a PSP Phase 2/3 trial after 3 patients treated with RT001 in PSP Expanded Access protocols showed encouraging results after more than a year on drug.

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            Lead Product(s): NTX-001

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 28, 2020

            Details:

            Neuraptive will conduct a Phase 2 study evaluating the safety and efficacy of NTX-001 vs standard of care in patients with acute single transected peripheral nerve injuries of the upper extremities.

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            Lead Product(s): PLX-200

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 April 08, 2020

            Details:

            Company has received an IND approval from the U.S.FDA to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.

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            Lead Product(s): PMN310

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 April 07, 2020

            Details:

            Both posters highlight data for antibodies that are highly selective for toxic vs. physiologically important forms of proteins implicated in AD and a variety of neurodegenerative diseases.

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            Lead Product(s): ANPD001

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: OrbiMed

            Deal Size: $70.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing April 01, 2020

            Details:

            The funding will support the completion of all remaining IND-enabling studies and FDA submission of the IND relating to Aspen's lead product (ANPD001).

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            Lead Product(s): IMS001

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 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 Product Name: Undisclosed

            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 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 Product Name: Undisclosed

            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): Linoleic Acid

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 Product Name: Undisclosed

            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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