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Details:
Axsome intends to use the proceeds to advance its late-stage pipeline, including AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the treatment of central nervous system conditions.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $225.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 30, 2023
Details:
Axsome intends to use the proceeds to advance its late-stage pipeline, including AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the treatment of central nervous system conditions.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $225.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 28, 2023
Details:
Axsome intends to use the proceeds to advance its late-stage pipeline, including AXS-05 (dextromethorphan), a novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the treatment of central nervous system conditions.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering June 27, 2023
Details:
AXS-05 (dextromethorphan-bupropion) is novel, oral, patent protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease (AD) agitation and other CNS disorders.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2022
Details:
AXS-05 (dextromethorphan-bupropion) is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for treatment of AD agitation and other CNS disorders.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2022
Details:
Results with AXS-05 (dextromethorphan-bupropion), demonstrate rapid reductions in anhedonic symptoms, and are consistent with observed improvements in patient functioning and quality of life associated with treatment with AXS-05 in clinical trials.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
AXS-05 (dextromethorphan) was generally well tolerated in the trial. The most common adverse events with AXS-05 were dizziness, nausea, dry mouth, decreased appetite, and anxiety. AXS-05 was not associated with psychotomimetic effects, weight gain, or sexual dysfunction.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Under the terms of the amendment, the size of the term loan facility was increased and the amount available at the Company’s option immediately upon approval of AXS-05 in major depressive disorder was increased.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 18, 2021
Details:
AXS-05 (dextromethorphan-bupropion) is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2021
Details:
AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation, major depressive disorder, and other central nervous system (CNS) disorders.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
The committed capital strengthens the Company’s balance sheet through the anticipated commercial launches of its two lead product candidates, AXS-05 for major depressive disorder and AXS-07 for migraine, and extends its cash runway, based on current operating plans.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing September 29, 2020
Details:
Results of the meeting confirm the pivotal status of the previously completed positive ADVANCE-1 trial, and the establishment of the superiority of AXS-05 over its components (component contribution) in the treatment of AD agitation.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3 open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient to support an NDA for AXS-05 in MDD, and Axsome remains on track to submit the planned NDA in the fourth quarter of 2020.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 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.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: AXS-05
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 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.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
Details:
A 312-subject Phase 3 clinical trial, STRIDE-1 in patients with treatment-resistant depression failed to achieve the primary endpoint.
Lead Product(s): Bupropion Hydrochloride,Dextromethorphan
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 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.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2020
Details:
STRIDE-1 is a Phase 3, randomized, double-blind, active controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment resistant depression.
Lead Product(s): Dextromethorphan,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2020
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