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Find Clinical Drug Pipeline Developments & Deals by Axsome Therapeutics

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hercules Capital

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing September 29, 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.

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            Lead Product(s): Meloxicam,Rizatriptan Benzoate

            Therapeutic Area: Neurology Product Name: AXS-07

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 24, 2020

            Details:

            AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial.

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: AXS-12

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of an NDA (New Drug Application) for approval of AXS-12 for the treatment of cataplexy in narcolepsy.

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            Lead Product(s): Meloxicam,Rizatriptan Benzoate

            Therapeutic Area: Neurology Product Name: AXS-07

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 17, 2020

            Details:

            The results of the Phase 3 MOMENTUM trial were one of the 12 selected abstracts. The Phase 3 Momentum Trial evaluated efficacy and safety of AXS-07 for the acute treatment of migraine.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Neurology Product Name: AXS-05

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 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.

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: AXS-12

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 28, 2020

            Details:

            Axsome will present efficacy & safety data from the CONCERT Ph 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the APSS. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 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.

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: AXS-12

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 05, 2020

            Details:

            AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor. Axsome previously received Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 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.

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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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