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Find FDA Investigational New Drug (IND) Submissions for Neurology

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            Lead Product(s): IkT-148009

            Therapeutic Area: Neurology Product Name: IkT-148009

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $15.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering November 03, 2020

            Details:

            Inhibikase Therapeutics has filed two INDs for IkT-148009, one for PD and one for the treatment of PD-related gastrointestinal complications, and it expects to commence the first dosing of PD patients shortly after the conclusion of the offering.

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            Lead Product(s): AMT-143

            Therapeutic Area: Neurology Product Name: AMT-143

            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 October 20, 2020

            Details:

            AmacaThera has received approval from Health Canada to proceed to a Phase 1 clinical trial with its lead asset, a long-acting anesthetic formulation for the treatment of post-surgical pain.

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            Lead Product(s): ANK-700

            Therapeutic Area: Neurology Product Name: ANK-700

            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 September 24, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).

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            Lead Product(s): PrabotulinumtoxinA

            Therapeutic Area: Neurology Product Name: ABP-450

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Daewoong Pharmaceutical

            Deal Size: $25.0 million Upfront Cash: Undisclosed

            Deal Type: Investment September 03, 2020

            Details:

            The milestone is expected to provide funding AEON's clinical programs into 2021. The U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ABP-450 to treat cervical dystonia.

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            Lead Product(s): PN-1007

            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 June 05, 2020

            Details:

            In a dose titration study in mice, intravenous administration of PN-1007 was able to efficiently remove all anti-MAG IgM antibodies, strongly supporting the anticipated effective dose range for the upcoming phase I/IIa study in patients.

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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): Sodium oligomannate

            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 27, 2020

            Details:

            Green Valley Pharma’s scientists have suggested that GV-971 may work by altering the balance of microorganisms in the GI tract that contribute to inflammation in the central nervous system.

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            Lead Product(s): RLS-0071

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Children’s Research Holdings

            Deal Size: $14.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing April 21, 2020

            Details:

            Proceeds will fund advancement of programs addressing acute lung injury due to COVID-19 and severe birth asphyxia (HIE).

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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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