FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Neurology Drugs in Phase II/III Clinical Development in UNITED STATES

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            Lead Product(s): Sodium 4-Phenylbutyrate,Tauroursodeoxycholic Acid

            Therapeutic Area: Neurology Product Name: AMX0035

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Morningside

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing July 01, 2020

            Details:

            Proceeds enable continued investment in lead product candidate AMX0035 in ALS and Alzheimer’s disease.

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            Lead Product(s): Blarcamesine

            Therapeutic Area: Neurology Product Name: Anavex 2-73

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 01, 2020

            Details:

            The Phase 2/3 study will use a convenient once-daily oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Safety and efficacy will be investigated in at least 69 patients over a 12-week treatment period including ANAVEX®2-73-specific precision medicine biomarkers.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Neurology Product Name: AXS-05

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 26, 2020

            Details:

            The U.S.FDA has granted Breakthrough Therapy designation for AXS-05 for the treatment of Alzheimer’s disease agitation. AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

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            Lead Product(s): Atuzaginstat

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            The International Nonproprietary Naming Committee of the World Health Organization (WHO) has selected atuzaginstat as the proposed International Nonproprietary Name, or pINN, for the company’s lead product candidate COR388.

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            Lead Product(s): Blarcamesine

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2020

            Details:

            The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 of ANAVEX®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III 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:

            AXS-05 met the primary endpoint in the ADVANCE-1 Phase 2/3 trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo.

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            Lead Product(s): Blarcamesine

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 23, 2020

            Details:

            Clinically meaningful biomarkers identified in ANAVEX®2-73 (Blarcamesine) studies demonstrate a significant impact on clinical outcomes at one year (57 weeks) and beyond three years (148 weeks)

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            Lead Product(s): Vazegepant

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 23, 2020

            Details:

            The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 20, 2020

            Details:

            Company is accelerating the completion of the ADVANCE-1 Ph 2/3 trial of AXS-05 in Alzheimer’s disease agitation to ensure the safety of this patient population during the COVID-19 pandemic.

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            Lead Product(s): COR388

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 16, 2020

            Details:

            Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis.

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