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Details:
The funding helps BioCorRx to focus on the clinical development of BICX104 (naltrexone) a biodegradable, long-acting subcutaneous pellet in combination with Bupropion. It is currently evaluated in preclinical studies for methamphetamine use disorder.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $11.0 million Upfront Cash: Undisclosed
Deal Type: Funding February 28, 2024
Details:
Contrave, also marketed as Mysimba is an extended release fixed dose combination of naltrexone HCL/bupropion HCL indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.
Lead Product(s): Naltrexone Hydrochloride,Bupropion Hydrochloride
Therapeutic Area: Nutrition and Weight Loss Product Name: Contrave
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 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 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:
AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg).
Lead Product(s): Dextromethorphan Hydrobromide,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Auvelity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
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:
AUVELITY (dextromethorphan hydrobromide) is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week.
Lead Product(s): Dextromethorphan Hydrobromide,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Auvelity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 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:
CX-101 is an investigational drug that is being studied for smoking cessation.The Phase 3 program builds on the successful Phase 2b findings and evaluates a mixed-weight population at a fixed-dose combination of CX-101 (naltrexone/bupropion 32 mg/360 mg total daily dose).
Lead Product(s): Naltrexone Hydrochloride,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: CX-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
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:
The study assessed treatment patterns and HRU among 3,665 patients diagnosed with alcohol dependence who were treated with VIVITROL® (naltrexone for extended-release injectable suspension (XR-NTX)).
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary antitumor activity of CPI-300.
Lead Product(s): Bupropion Hydrochloride
Therapeutic Area: Oncology Product Name: CPI-300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2021
Details:
This is the second published study evaluating efficacy and safety of naltrexone for extended-release injectable suspension plus oral extended-release bupropion administered daily as a combination treatment methamphetamine use disorder.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
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 14, 2021
Details:
A combination of two medications, injectable naltrexone and oral bupropion, was safe and effective in treating adults with moderate or severe methamphetamine use disorder in a double-blind, placebo-controlled Phase III clinical trial.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
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 13, 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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