Neurology | Phase II/ Phase III Developments | UNITED STATES

Amylyx Pharmaceuticals

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Amylyx Pharmaceuticals Raises $30 Million in Series B Funding

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.

Anavex Life Sciences

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Anavex Life Sciences Doses First Patient in EXCELLENCE Phase 2/3 Clinical Trial of ANAVEX®2-73 (Blarcamesine) in Patients with Rett Syndrom...

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.

Axsome Therapeutics

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Presented with upbeat Alzheimer's agitation data, FDA sees another 'breakthrough' in Axsome's AXS-05

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.

Cortexyme

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Cortexyme Announces “Atuzaginstat” Selected as First-in-Class Nonproprietary Name for COR388

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.

Anavex Life Sciences

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Anavex Life Sciences Gets Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73

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.

Axsome Therapeutics

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Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation

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.

Anavex Life Sciences

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Anavex Life Sciences Announces Publication of Clinical Data for ANAVEX®2-73 (blarcamesine) in Alzheimer’s Disease

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)

Biohaven Pharmaceuticals

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Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migrain

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.

Axsome Therapeutics

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Axsome Accelerates Completion Of Advance-1 Phase 2/3 Trial Of Axs-05 In Alzheimer's Disease Agitation

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.

Cortexyme

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Cortexyme Announces Gain Trial in Alzheimer’s Disease Has Reached Enrollment Milestone of 300 Patients

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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Amylyx Pharmaceuticals

Amylyx Pharmaceuticals Raises $30 Million in Series B Funding

Anavex Life Sciences

Anavex Life Sciences Doses First Patient in EXCELLENCE Phase 2/3 Clinical Trial of ANAVEX®2-73 (Blarcamesine) in Patients with Rett Syndrom...

Axsome Therapeutics

Presented with upbeat Alzheimer's agitation data, FDA sees another 'breakthrough' in Axsome's AXS-05

Cortexyme

Cortexyme Announces “Atuzaginstat” Selected as First-in-Class Nonproprietary Name for COR388

Anavex Life Sciences

Anavex Life Sciences Gets Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73

Axsome Therapeutics

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation

Anavex Life Sciences

Anavex Life Sciences Announces Publication of Clinical Data for ANAVEX®2-73 (blarcamesine) in Alzheimer’s Disease

Biohaven Pharmaceuticals

Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migrain

Axsome Therapeutics

Axsome Accelerates Completion Of Advance-1 Phase 2/3 Trial Of Axs-05 In Alzheimer's Disease Agitation

Cortexyme

Cortexyme Announces Gain Trial in Alzheimer’s Disease Has Reached Enrollment Milestone of 300 Patients