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Axsome Therapeutics, Inc. (AXSM)

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Previous Close70.70
Open70.61
Bid69.70 x 1000
Ask71.29 x 1200
Day's Range69.90 - 71.92
52 Week Range20.48 - 109.94
Volume232,420
Avg. Volume387,660
Market Cap2.661B
Beta (5Y Monthly)2.81
PE Ratio (TTM)N/A
EPS (TTM)-2.64
Earnings DateNov 05, 2020 - Nov 09, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est146.80
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  • Did Axsome Therapeutics, Inc. (NASDAQ:AXSM) Insiders Buy Up More Shares?
    Simply Wall St.

    Did Axsome Therapeutics, Inc. (NASDAQ:AXSM) Insiders Buy Up More Shares?

    It is not uncommon to see companies perform well in the years after insiders buy shares. The flip side of that is that...

  • Why Axsome Therapeutics Stock Is Sinking Today
    Motley Fool

    Why Axsome Therapeutics Stock Is Sinking Today

    Shares of Axsome Therapeutics (NASDAQ: AXSM) were sinking 6.8% lower as of 11:29 a.m. EDT on Tuesday. The company announced a $225 million loan facility with Hercules Capital before the market opened. The main reason for Axsome's shares falling, though, was that Bank of America analyst Ashwani Verma initiated coverage on the stock with an underperform rating and a price target of $66 -- more than 13% below the stock's closing price on Monday.

  • GlobeNewswire

    Axsome Therapeutics Announces $225 Million Term Loan Facility with Hercules Capital

    Non-dilutive committed capital extends cash runway into at least 2024 Facility strengthens balance sheet through anticipated commercial launches of Axsome’s two lead CNS product candidatesNEW YORK, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, has secured a $225 million term loan facility with Hercules Capital, Inc. (NYSE: HTGC). 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 (MDD) and AXS-07 for migraine, and extends its cash runway into at least 2024, based on current operating plans.“The committed non-dilutive capital from this term loan facility increases our financial flexibility as we execute on the anticipated upcoming commercial launches of our first two potentially life-changing investigational medicines for patients living with depression and migraine,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Simultaneously we will continue to advance the rest of our differentiated late-stage CNS pipeline which includes two other Breakthrough Therapy designated programs, AXS-05 in Alzheimer’s disease agitation and AXS-12 in narcolepsy, as we build a leading CNS company.”“Hercules is proud to partner with Axsome ahead of the filing of its New Drug Applications for AXS-05 in depression and for AXS-07 in migraine, and to support its work to develop novel treatments for the millions of patients with CNS disorders,” said Scott Bluestein, Chief Executive Officer and Chief Investment Officer of Hercules Capital. “The significant commitment from Hercules aligns with Axsome’s growth plans and provides an example of the breadth of our platform and our ability to finance life sciences companies through all stages of development.”Under the terms of the new $225 million term loan facility, $60 million may be drawn at closing; $115 million may be drawn at the Company’s option, in three separate tranches, upon approval of AXS-05 in MDD, upon approval of AXS-07 in migraine, and upon certain combined sales criteria for AXS-05 and AXS-07; and an additional $50 million is available, subject to the approval of Hercules Capital, to support future strategic initiatives, including further pipeline advancement or expansion. Of the initial $60 million, the Company drew down $50 million at closing, with the additional $10 million available to be drawn at the Company’s option. A portion of the initial drawdown was used to repay the Company’s previously existing $20 million principal loan with Silicon Valley Bank along with associated final payment fees. The new term loan facility bears interest at a calculated prime-based variable rate currently at 9.15%. It matures in October 2025 and has an initial interest-only payment period of 30 months, which may be extended to up to 48 months upon the drawing of future tranches. Axsome will issue warrants to purchase 15,541 shares of Axsome common stock upon initial funding of the facility.Additional details of the loan agreement, will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.About Hercules Capital, Inc.Hercules Capital, Inc. (NYSE: HTGC) is the leading and largest specialty finance company focused on providing senior secured venture growth loans to high-growth innovative venture capital-backed companies in a broad variety of technology, life sciences and sustainable and renewable technology industries. Since inception (December 2003), Hercules has committed more than $10.5 billion to over 500 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing.Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, with or without a special protocol assessment); the potential for our clinical trials to provide a basis for accelerated approval of our product candidates for the treatment of several indications and accelerate their development timelines and commercial paths to patients (including, but not limited to, with or without a breakthrough therapy designation); the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and our ability to fund our commercial launch, which assumes product approval; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com

  • GlobeNewswire

    Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine

    Significantly faster time to pain relief as compared to rizatriptan (p<0.001)Significantly less relapse of migraine pain as compared to rizatriptan (p=0.001)Benefits demonstrated in patients with a history of inadequate response to prior acute treatmentsNEW YORK, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that 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. These findings were presented at the live sessions of the 2020 American Academy of Neurology (AAN) Science Highlights platform held virtually September 23-24.The MOMENTUM study was a randomized, double-blind, placebo- and active-controlled trial which enrolled only patients with a history of inadequate response to prior acute migraine treatments. A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC™ meloxicam/10 mg rizatriptan), rizatriptan (10 mg), MoSEIC™ meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. Rizatriptan, an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine [1-3].AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p<0.001). AXS-07 substantially and significantly reduced relapse of migraine pain as compared to rizatriptan, with 45.2% of rizatriptan-treated patients experiencing relapse compared to 21.2% of AXS-07 patients over 48 hours after dosing (p=0.001).The results on time to migraine pain relief and relapse are consistent with the superiority of AXS-07 over rizatriptan on several other efficacy measures, as previously reported, including rescue medication use (p<0.001), sustained pain relief over 24 hours (p=0.006) and 48 hours (p=0.003), sustained pain freedom over 24 hours (p=0.038) and 48 hours (p=0.003), Patient Global Impression of Change (p=0.022) at 2 hours, and return to normal functioning at 24 hours (p=0.027). Also as previously reported, AXS-07 met both co-primary endpoints of the trial by demonstrating a greater percentage of patients achieving pain freedom (p<0.001) and absence of most bothersome symptom (p=0.002), 2 hours after dosing, as compared to placebo."The strong efficacy of AXS-07 in patients with a history of inadequate response is especially notable since it was demonstrated over one of the most effective triptans,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “With its demonstrated rapid, superior, and durable effects in the acute treatment of migraine, AXS-07 may help address the need for more efficacious treatments for this debilitating neurological condition.”AXS-07 was safe and well tolerated in the trial. The most commonly reported adverse events with AXS-07 were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%.AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 is thought to act by inhibiting CGRP release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission, and central sensitization. Axsome’s MoSEIC™ technology significantly increases the speed of absorption of the meloxicam component after oral administration while maintaining a long plasma half-life. AXS-07 is covered by 44 issued U.S. and international patents providing protection out to 2036, and Axsome maintains worldwide rights.About the MOMENTUM TrialMOMENTUM (Maximizing Outcomes in Treating Acute Migraine) was a Phase 3, randomized, double-blind, multicenter, controlled trial to assess the efficacy and safety of AXS-07 in the acute treatment of moderate and severe migraine. Eligible patients must have had a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). A total of 1,594 patients were randomized in a 2:2:2:1 ratio to treatment with AXS-07, rizatriptan, MoSEIC™ meloxicam, or placebo. The two co-primary endpoints of the trial were the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffered from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing, for AXS-07 as compared to placebo. Superiority of AXS-07 to the rizatriptan and MoSEIC™ meloxicam arms (component contribution) was to be established based on sustained freedom from headache pain from two to 24 hours after dosing (key secondary endpoint). The MOMENTUM study was conducted pursuant to an FDA Special Protocol Assessment (SPA).About MigraineOver 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound. It is estimated that migraine accounts for $78 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) costs each year in the United States [4]. Published surveys of migraine sufferers indicate that more than 70% are not fully satisfied with their current treatment, that nearly 80% would try a new therapy, and that they desire treatments that work faster, more consistently, and result in less symptom recurrence [5,6].About AXS-07AXS-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/1D agonist. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is covered by more than 44 issued U.S. and international patents which provide protection out to 2036. AXS-07 is not approved by the FDA.About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.References 1. Dodick DW. Migraine. Lancet. 2018;391(10127):1315-1330. 2. Xu H, Han W, Wang J, Li M. Network meta-analysis of migraine disorder treatment by NSAIDs and triptans. J Headache Pain. 2016;17(1):113. 3. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT(1B/1D) agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet. 2001 Nov 17;358(9294):1668-75. 4. Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol. 2017 Apr; 81(4):479-484. 5. Smelt AF, Louter MA, Kies DA, Blom JW, Terwindt GM, van der Heijden GJ, De Gucht V, Ferrari MD, Assendelft WJ. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933. 6. Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, with or without a special protocol assessment); the potential for our clinical trials to provide a basis for accelerated approval of our product candidates for the treatment of several indications and accelerate their development timelines and commercial paths to patients (including, but not limited to, with or without a breakthrough therapy designation); the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com

  • Axsome Expedites Development Plan for Narcolepsy Candidate
    Zacks

    Axsome Expedites Development Plan for Narcolepsy Candidate

    Axsome (AXSM) accelerates the development plan for AXS-12 to treat narcolepsy after a Breakthrough Therapy meeting with the FDA authorities. Stock dips.

  • GlobeNewswire

    Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting

    Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021 Extensive patient safety database, previously obtained through Pfizer exclusive license, to support NDA filingExtensive array of completed nonclinical studies sufficient to support NDA filingCompany to host conference call today at 8:00 AM EasternNEW YORK, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the development plan for AXS-12 for the treatment of narcolepsy has been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy.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. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study. Axsome intends to initiate this trial in 1Q 2021. Patients completing this trial will be eligible to enroll in an open-label safety extension study.Also, as part of the expedited development plan, it was established that the data from numerous short-term and long-term clinical trials of patients treated with reboxetine, and the data from a full range of completed nonclinical studies with reboxetine, previously obtained through an exclusive license from Pfizer, can be used to support the filing of an NDA for AXS-12.“Axsome is very pleased with the FDA feedback from our recent Breakthrough Therapy meeting, which resulted in an expedited path to a potential NDA filing for AXS-12 in the treatment of cataplexy in narcolepsy,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Narcolepsy is a debilitating condition that interferes with almost every aspect of a patient’s life. Our approach to the development of AXS-12 for narcolepsy reflects our commitment to accelerating the innovation of potentially life-changing medicines for the many patients living with serious CNS disorders.”Breakthrough Therapy Meeting Outcomes * One Phase 3 trial of AXS-12 in patients with narcolepsy will be conducted to support, along with the completed Phase 2 CONCERT trial, an NDA filing for AXS-12 in the treatment of cataplexy in narcolepsy. * The existing short-term and long-term safety database of more than 2,500 patients treated with reboxetine, previously obtained through an exclusive license from Pfizer, along with the safety data from the completed and planned studies of AXS-12 in patients with narcolepsy, would be sufficient to support an NDA filing for AXS-12. * Certain existing, completed clinical pharmacology (e.g. human pharmacokinetic) studies of reboxetine, previously obtained through an exclusive license from Pfizer, are considered sufficient to support an NDA filing for AXS-12. * The extensive package of completed nonclinical studies of reboxetine, previously obtained through an exclusive license from Pfizer, are considered sufficient to support an NDA filing for AXS-12.In August 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-12 for the treatment of cataplexy in narcolepsy. A Breakthrough Therapy designation is granted to potentially expedite development and review timelines for a promising investigational medicine when preliminary clinical evidence indicates it may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for a serious or life-threatening condition. The Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in narcolepsy was supported by the positive results from the Phase 2 CONCERT study, a randomized, double-blind, placebo-controlled, crossover, multicenter U.S. trial. In the trial, 21 patients with a diagnosis of narcolepsy with cataplexy were treated for 2 weeks with AXS-12 or with placebo, followed by a crossover to the other treatment after a 1-week down-titration and washout period. AXS-12 met the primary endpoint demonstrating a highly statistically significant reduction from baseline in the mean weekly number of cataplexy attacks, averaged for the 2-week treatment period (overall treatment effect), as compared to placebo (p<0.001), and at the end of the 2-week treatment period (p=0.002). AXS-12 also significantly improved excessive daytime sleepiness compared to placebo, as measured by the Epworth Sleepiness Scale and by the frequency of inadvertent naps (p=0.003 and p<0.001, respectively). In addition, AXS-12 significantly improved cognitive function compared to placebo over the 2-week treatment period as measured by the Ability to Concentrate item of the Narcolepsy Symptom Assessment Questionnaire (p<0.001). AXS-12 was well tolerated in this trial with the most commonly reported adverse events being anxiety, constipation, and insomnia.Conference Call InformationAxsome will host a conference call and webcast with slides today at 8:00 AM Eastern to discuss the expedited development plan for AXS-12 for the treatment of narcolepsy following a Breakthrough Therapy meeting with the FDA. To participate in the live conference call, please dial (844) 698-4029 (toll-free domestic) or (647) 253-8660 (international), and use the passcode 9584742. The live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.About FDA Breakthrough Therapy DesignationBreakthrough Therapy designation is granted by the FDA in order to expedite the development and review of drugs for serious or life-threatening conditions. In order to receive Breakthrough Therapy designation, a drug must demonstrate preliminary clinical evidence that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Breakthrough Therapy designation provides an organizational commitment involving senior managers from the FDA, more intensive FDA guidance on an efficient drug development program, and greater access to and more frequent communication with the FDA throughout the entire drug development and review process. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, Breakthrough Therapy designated products are eligible for Priority Review, where the FDA has a goal to take action on an application within six months, as opposed to ten months under standard review. Breakthrough Therapy designation does not change the standards for approval.About NarcolepsyNarcolepsy is a serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Narcolepsy afflicts an estimated 185,000 individuals in the U.S. Cataplexy is seen in an estimated 70% of narcolepsy patients and is a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement. Narcolepsy interferes with cognitive, psychological, and social functioning, increases the risk of work- and driving-related accidents, and is associated with a 1.5-fold higher mortality rate.About AXS-12AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor under development for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is an investigational drug product not approved by the FDA.About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, with or without a special protocol assessment); the potential for our clinical trials to provide a basis for accelerated approval of our product candidates for the treatment of several indications and accelerate their development timelines and commercial paths to patients (including, but not limited to, with or without a breakthrough therapy designation); the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com

  • GlobeNewswire

    Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Committee as Featured Presentation

    Data from MOMENTUM Phase 3 trial to be presented at the 2020 AAN Science Highlights PlatformNEW YORK, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Phase 3 data for AXS-07 in the acute treatment of migraine has been selected as a featured presentation at the 2020 American Academy of Neurology (AAN) Science Highlights platform, to be held virtually September 23, 2020 at 12:15 PM Central Time. AXS-07 (MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine. The presentation will highlight new insights from the Phase 3 MOMENTUM trial of AXS-07, and will be followed with live Q&A.The AAN Science Committee reviewed over 150 late-breaking, or Emerging Science, abstracts and selected 12 to be featured presentations on the new 2020 AAN Science Highlights platform. The results of the Phase 3 MOMENTUM trial were one of the 12 selected abstracts. According to the AAN, the selected abstracts contain timely, significant, and innovative content.Details of the presentation are as follows:Title: Efficacy and Safety of AXS-07 for the Acute Treatment of Migraine: Results from the MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 Randomized, Double-blind, Active- and Placebo-controlled Study Session: Emerging Science: Alzheimer's, Migraine, ALS and CIDP Date: Wednesday September 23, 2020 Time: 12:15 – 12:30 PM Central Time Location: The 2020 AAN Science Highlights virtual platform will be available to everyone. Attendees will be asked to register to access the session at: https://www.aan.com/education-and-research/research/2020-aan-science-highlights/. A recording of the webinar will be available on the AAN Science Highlights platform following the session.A copy of the presentation will be available shortly after the meeting on Axsome’s website at www.axsome.com.About AXS-07AXS-07 is a novel, oral, multi-mechanistic, investigational medicine 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/1D 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 Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com

  • Hedge Funds Keep Piling Into Axsome Therapeutics, Inc. (AXSM)
    Insider Monkey

    Hedge Funds Keep Piling Into Axsome Therapeutics, Inc. (AXSM)

    At the end of February we announced the arrival of the first US recession since 2009 and we predicted that the market will decline by at least 20% in (see why hell is coming). We reversed our stance on March 25th after seeing unprecedented fiscal and monetary stimulus unleashed by the Fed and the Congress. […]

  • GlobeNewswire

    Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder

    Rapid, durable, and statistically significant improvement demonstrated in patient-reported depressive symptoms, as measured by the QIDS-SR-16 total score compared to placebo (p=0.001)Clinical response on the QIDS-SR-16 demonstrated in 53% of patients with AXS-05 compared to 33% for placebo (p<0.001)Significant improvement on the PGI-I demonstrated, with 47% of patients reporting their depression being “very much” or “much” improved with AXS-05 versus 31% with placebo (p=0.007)Statistically significant improvement at week 1 versus placebo in QIDS-SR-16 total score (p=0.016), and PGI-I (p=0.008), compared to placeboPotentially first-and-only, oral NMDA receptor antagonist with multimodal activity for the treatment of depressionNEW YORK, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, rapidly and significantly improved patient-reported outcomes of depression in patients with major depressive disorder (MDD) in the GEMINI Phase 3 trial. These findings were presented at the 33rd Congress of the European College of Neuropsychopharmacology (ECNP), being held virtually September 12-15.The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS-05 (dextromethorphan/bupropion modulated delivery tablet) or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks. Two patient-reported outcomes (PROs) for depression were assessed in this trial: the Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16), and the Patient Global Impression of Improvement (PGI-I) for depression. The QIDS-SR-16 is a well-established PRO that was the primary outcome measure in the landmark NIH-funded STAR*D trial of antidepressant treatments3. A PRO is a report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. PROs therefore provide a measurement of patients’ perception of their own depression status as a result of an intervention. The PROs complement the clinician-rated measures, such as the Montgomery-Åsberg Depression Rating Scale (MADRS), that were also assessed in the GEMINI trial.AXS-05 demonstrated a highly statistically significant reduction in patient-reported depressive symptoms compared to placebo at Week 6, with mean reductions from baseline in the QIDS-SR-16 total score of 7.8 points for AXS-05 and 5.4 points for placebo, representing 48% and 34% reductions from baseline, respectively (p=0.001). AXS-05 rapidly and durably improved patient-reported depressive symptoms as compared to placebo with statistical significance on the QIDS-SR-16 total score demonstrated at Week 1 (p=0.016), the earliest time point assessed, at Week 2 (p<0.001), and at all time points thereafter. Clinical response on the QIDS-SR-16 (defined as ≥50% improvement) was statistically significantly greater for AXS-05 compared to placebo at Week 1 (p=0.048), at Week 2 (p<0.001), and at every time point thereafter, being achieved by 53.4% of AXS-05 patients compared to 32.9% of placebo patients at Week 6 (p<0.001).On the patient-reported global measure of depression, the PGI-I, AXS-05 demonstrated highly statistically significant improvements as compared to placebo, with 47.2% of patients treated with AXS-05 reporting that their depression was “very much” or “much” improved compared to 31.3% of placebo patients at Week 6 (p=0.007). Improvement on the PGI-I with AXS-05 as compared to placebo was rapid and durable with statistical significance demonstrated at Week 1 (p=0.008) and at all time points thereafter.The results on these patient-reported measures are consistent with those observed with the corresponding clinician-rated scales, the MADRS and the Clinical Global Impression of Improvement (CGI-I). As previously reported, AXS-05 met the primary endpoint in the GEMINI trial by demonstrating a highly statistically significant reduction in the MADRS total score compared to placebo at Week 6, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo (p=0.002). AXS-05 also demonstrated statistically significant improvement at Week 6 compared to placebo on the CGI-I (p=0.016). Rapid improvement in depressive symptoms was also demonstrated on these clinician-rated scales, with statistically significant improvements starting at Week 1 and every timepoint thereafter (MADRS p=0.007, CGI-I p=0.035)."The positive results with AXS-05 on patient-reported outcomes are significant since depression, by its very nature, involves symptoms that may be unobservable and known only to the patient,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “These patient-reported outcomes mirror the results previously reported with clinician-rated scales and confirm the rapid and substantial antidepressant effects of AXS-05. With its novel oral glutamatergic mechanism targeting NMDA, AXS-05 may help to address the needs of the many patients living with depression, about two thirds of whom fail to respond to currently available antidepressants.”AXS-05 was well tolerated in the trial. The most commonly reported adverse events in the AXS-05 arm were dizziness, nausea, headache, diarrhea, somnolence, and dry mouth. Treatment with AXS-05 was not associated with psychotomimetic effects or weight gain.AXS-05 is a novel, oral, non-competitive NMDA receptor antagonist, also known as a glutamate receptor modulator, a new mechanism of action which is thought to help enhance synaptic connections and improve the communication between brain cells in people with major depressive disorder. In addition, AXS-05 is a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating MDD. The multimodal actions of AXS-05 may be complementary and synergistic for the treatment of this biologically-based condition. AXS-05 is covered by 45 issued U.S. and international patents providing protection out to 2034, and Axsome maintains worldwide rights.AXS-05 was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in March 2019.About the GEMINI TrialGEMINI (Glutamatergic and Monoaminergic Modulation in Depression) was a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial of AXS-05 in patients with major depressive disorder (MDD) conducted in the U.S. A total of 327 patients with a confirmed diagnosis of moderate to severe MDD were randomized in a 1:1 ratio to receive AXS-05 (45 mg dextromethorphan/105 mg bupropion) (n=163), or placebo (n=164), twice daily for 6 weeks. The primary endpoint of the study was the change from baseline in the total score of the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-rated scale, at Week 6. Two patient-reported outcomes (PROs) for depression were also assessed: the Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16), and the Patient Global Impression of Improvement (PGI-I) for depression. The mean MADRS total scores at baseline were 33.6 for the AXS-05 group and 33.2 for the placebo group. The mean QIDS-SR-16 total scores at baseline were 16.2 for the AXS-05 group and 15.8 for the placebo group. P-values were calculated based on least square mean estimates.About the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) is a well-established, 16-item, validated rating scale used to provide a patient-reported assessment of depression. The scale is used to rate the severity of depression as assessed by the patient across nine question domains comprising sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, changes in appetite or weight, and psychomotor agitation or retardation. The total score ranges from 0 to 27 with higher scores indicating more severe depression.About Major Depressive Disorder (MDD)Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and which impairs social, occupational, educational, or other important functioning. In severe cases, MDD can result in suicide. According to the National Institutes of Health, an estimated 7.1% of U.S. adults, or approximately 17 million, experience MDD each year1. According to the World Health Organization (WHO), depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease2. Nearly two thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy3, highlighting the need for additional therapies with new mechanisms of action. The majority of initial failures also fail second-line treatment. Patients diagnosed with MDD are defined as having treatment resistant depression (TRD) if they have failed to respond to two or more antidepressant therapies.About AXS-05AXS-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 45 issued U.S. and international patents which provide protection out to 2034. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of MDD. AXS-05 is not approved by the FDA.About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.References1.        National Institute of Mental Health. (2017). Major Depression. Retrieved from https://www.nimh.nih.gov/health/statistics/major-depression.shtml.2.        World Health Organization. Fact Sheets: Depression, accessed October 9, 2018, http://www.who.int/en/news- room/fact-sheets/detail/depression.3.        Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com   www.axsome.com

  • GlobeNewswire

    Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress

    NEW YORK, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present clinical data on AXS-05 in the treatment of major depressive disorder (MDD) at the 33rd Congress of the European College of Neuropsychopharmacology (ECNP), to be held virtually, September 12-15. AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist. The poster presentation will highlight new insights from the Phase 3 GEMINI trial. Details of the presentation are as follows:Title: Efficacy and safety of AXS-05, an oral, NMDA receptor antagonist with multimodal activity in major depressive disorder Poster Number: P.327 Date: Saturday September 12 – Tuesday September 15, 2020 Location: The 2020 ECNP Virtual Congress will be available to everyone. Attendees will be asked to register to access the meeting platform at: https://www.ecnp.eu/Congress2020/ECNPcongress/registration/Registration.A copy of the presentation will be available shortly after the meeting on Axsome’s website at www.axsome.com.About AXS-05AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder, Alzheimer’s disease agitation, 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, a sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, a nicotinic acetylcholine receptor antagonist, and an inhibitor of microglial activation. 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 42 issued U.S. and international patents which provide protection out to 2034. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for major depressive disorder, Fast Track designation for treatment resistant depression, and Breakthrough Therapy and Fast Track designations for Alzheimer’s disease agitation. AXS-05 is not approved by the FDA.About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.Forward Looking StatementsCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com   www.axsome.com