Friday, October 04, 2019 9:59:29 AM
Cantor Global Healthcare Conference
October 2, 2019
https://finance.yahoo.com/news/axsome-therapeutics-continued-progress-2019-110000091.html
GEMINI
Phase 3 placebo-controlled trial of AXS-05 in MDD on track for readout of topline results in 4Q 2019
STRIDE-1
Phase 3 trial of AXS-05 in TRD on track for readout of topline results in 4Q 2019
MOMENTUM
Phase 3 trial of AXS-07 in migraine on track for readout of topline results in 4Q 2019
CONCERT
Phase 2 trial of AXS-12 in narcolepsy on track for readout of topline results in 4Q 2019
Cash runway into 4Q 2021
NEW YORK, Oct. 02, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, will participate in the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019. Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at 3:00 PM Eastern Time. The conference will be held at the InterContinental New York Barclay in New York, NY.
Dr. Tabuteau will provide the following update on the Company’s continued progress during the presentation:
AXS-05: AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: treatment resistant depression (TRD), major depressive disorder (MDD), Alzheimer’s disease (AD) agitation, and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of MDD and Fast Track designations for the treatment of TRD and for the treatment of AD agitation.
Depression
To date, approximately 75% of the targeted number of patients have been randomized into the GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD. Axsome remains on track to report topline efficacy results from both the GEMINI trial and the STRIDE-1 trial of AXS-05 in TRD in the fourth quarter of 2019.
An NDA filing for AXS-05 in the treatment of MDD is targeted for the second half of 2020.
Alzheimer’s Disease Agitation
To date, approximately 65% of the targeted number of patients have been randomized into the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer’s disease. Axsome continues to anticipate topline results from the ADVANCE-1 trial in the first half of 2020.
AXS-07: AXS-07 (MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral, investigational medicine with distinct dual mechanisms of action being developed for the acute treatment of migraine.
To date, more than 80% of the targeted number of patients have been randomized into the MOMENTUM Phase 3 trial of AXS-07 in the acute treatment of migraine. MOMENTUM is being conducted pursuant to an FDA Special Protocol Assessment (SPA). Axsome remains on track to report topline results from the MOMENTUM trial in the fourth quarter of 2019.
An NDA filing for AXS-07 in the acute treatment of migraine is targeted for the second half of 2020.
______________________________________________________
AXS-12: AXS-12 (reboxetine) is Axsome’s novel, oral, potent and highly selective norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. AXS-12 has been granted Orphan Drug Designation by the FDA for the treatment of narcolepsy.
To date, 70% of the targeted number of patients have been randomized into the CONCERT Phase 2 trial of AXS-12 in patients with narcolepsy. Axsome remains on track to report topline results from the CONCERT trial in the fourth quarter of 2019.
______________________________________________________
Financial Update
Axsome believes that its current cash will be sufficient to fund the Company’s anticipated operations, based on its current operating plans, into the fourth quarter of 2021, well beyond the readout of all of the above ongoing clinical trials.
As previously disclosed, Axsome currently does not anticipate future equity financings prior to the readout from its Phase 3 trials.
A live webcast and archive of the event can be viewed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at www.axsome.com.
About AXS-05
AXS-05 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. AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently approved therapies for major depressive disorder. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 36 issued U.S. and international patents which provide protection out to 2034. AXS-05 is not approved by the FDA.
About AXS-07
AXS-07 is a novel, oral, investigational medicine with distinct dual mechanisms of action under development for the acute treatment of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/D agonist. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is not approved by the FDA.
About AXS-12
AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug product not approved by the FDA.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 3 trial in major depressive disorder (MDD), and a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for smoking cessation treatment. AXS-07 is currently in a Phase 3 trial for the acute treatment of migraine. AXS-12 is currently in a Phase 2 trial in narcolepsy. AXS-05, AXS-07, AXS-09, and AXS-12 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
<<<
Recent AXSM News
- Axsome Therapeutics Recognizes May as Mental Health Awareness Month • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting • GlobeNewswire Inc. • 04/15/2024 11:00:00 AM
- Axsome Therapeutics to Report First Quarter 2024 Financial Results on May 6 • GlobeNewswire Inc. • 04/10/2024 11:00:00 AM
- Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder • GlobeNewswire Inc. • 04/01/2024 11:00:00 AM
- Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients • GlobeNewswire Inc. • 03/25/2024 11:00:00 AM
- Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy • GlobeNewswire Inc. • 03/25/2024 10:30:00 AM
- Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder • GlobeNewswire Inc. • 03/19/2024 11:00:00 AM
- Axsome Therapeutics to Present at the Leerink Partners Global Biopharma Conference • GlobeNewswire Inc. • 03/05/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 11:34:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 11:25:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:39:05 PM
- Axsome Therapeutics to Present at the TD Cowen 44th Annual Healthcare Conference • GlobeNewswire Inc. • 02/27/2024 12:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/23/2024 01:10:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 12:05:36 PM
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/20/2024 12:00:00 PM
- Market Cautiousness Ahead of Retail Giants’ Earnings; Oil Prices Dip • IH Market News • 02/20/2024 10:37:35 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 08:46:49 PM
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on February 20 • GlobeNewswire Inc. • 01/23/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 12:10:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/04/2024 12:11:55 PM
- Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones • GlobeNewswire Inc. • 01/04/2024 12:00:00 PM
- Axsome Therapeutics Presents New Data and Post-Hoc Analyses of Auvelity® in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting • GlobeNewswire Inc. • 12/11/2023 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/07/2023 09:05:40 PM
- Axsome Therapeutics Hosts Solriamfetol Virtual Investor Event with Expert Thought Leaders Today • GlobeNewswire Inc. • 12/07/2023 12:00:00 PM
- Axsome Therapeutics to Host Solriamfetol Virtual Investor Event on December 7 • GlobeNewswire Inc. • 11/22/2023 12:00:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM