Latest news with #AXS-05
Hamilton Spectator
05-05-2025
- Business
- Hamilton Spectator
Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Total 1Q 2025 net product revenue of $121.5 million, representing 62% year-over-year growth AUVELITY ® 1Q 2025 net product sales of $96.2 million, representing 80% year-over-year growth SUNOSI ® 1Q 2025 net product revenue of $25.2 million, representing 17% year-over-year growth SYMBRAVO ® approved for the acute treatment of migraine; commercial launch on track for June 2025 NDA for AXS-14 for the management of fibromyalgia submitted to the FDA Supplemental NDA submission for AXS-05 in Alzheimer's disease agitation on track for 3Q 2025 NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 2H 2025 Positive topline results of FOCUS Phase 3 trial of solriamfetol in ADHD announced Initiation of Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness anticipated in 2025 Positive topline results of EMERGE Phase 3 trial of SYMBRAVO in migraine patients with prior inadequate response to oral CGRP inhibitors announced Company to host conference call today at 8:00 AM Eastern NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the first quarter of 2025 and provided a general business update. 'The first quarter was strong and eventful, with the approval of SYMBRAVO for the acute treatment of migraine, continued growth of AUVELITY and SUNOSI, and significant advancements across our broad late-stage neuroscience pipeline,' said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. 'Commercial availability of SYMBRAVO is on track for this June, and preparations are underway to enable a successful launch. We have submitted our NDA for AXS-14 for the management of fibromyalgia, and are on track for our planned NDA submissions this year for AXS-05 in Alzheimer's disease agitation and for AXS-12 in cataplexy in patients with narcolepsy. Our development programs with solriamfetol continue to advance, with the recently announced Phase 3 topline results in ADHD and MDD, and progress across the Phase 3 trials in binge eating disorder and excessive sleepiness associated with shift work disorder. Overall, our neuroscience portfolio positions us to deliver potentially five marketed products across ten indications that collectively impact over 150 million patients in the U.S. alone. We look forward to continued momentum over the balance of 2025 as we execute on our mission to deliver transformative medicines to patients living with serious CNS conditions.' First Quarter 2025 Financial Highlights Financial Guidance Commercial Highlights AUVELITY SUNOSI SYMBRAVO Development Pipeline Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, late-stage, patent-protected product candidates addressing a broad range of serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below. AXS-05 AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer's disease (AD) agitation and smoking cessation. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation. Solriamfetol Solriamfetol is Axsome's dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). SYMBRAVO SYMBRAVO (MoSEIC™ meloxicam-rizatriptan) is Axsome's novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist indicated for the acute treatment of migraine with or without aura in adults. AXS-12 AXS-12 (reboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy. AXS-14 AXS-14 (esreboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. Scientific Presentations Corporate Update Anticipated Milestones Conference Call Information Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its first quarter 2025 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the 'Webcasts & Presentations' page of the 'Investors' section of the Company's website at . A replay of the conference call will be available for approximately 30 days following the live event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company 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 commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, 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 the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; 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 products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic 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 circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@ Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@
Yahoo
09-04-2025
- Health
- Yahoo
AAN 2025: Axsome Therapeutics' treatment for Alzheimer's agitation shows promise
On 7 April 2025 at the American Academy of Neurology (AAN) 2025 annual meeting held in San Diego, California, Axsome Therapeutics presented efficacy and safety data from the Phase III ACCORD-2 (NCT04797715) study evaluating AXS-05 (bupropion + dextromethorphan) for the treatment of agitation associated with Alzheimer's disease. The US Food and Drug Administration (FDA) granted AXS-05 fast track designation then breakthrough therapy designation for Alzheimer's agitation in May 2017 and June 2020. During the presentation, Axsome Therapeutics announced plans to file for FDA approval in the spring/summer of 2025. If approved, AXS-05 would become the second drug available for the treatment of Alzheimer's agitation in the US following years of off-label antipsychotic use, intensifying competition in the space. The primary endpoint in ACCORD-2 was met, as AXS-05 treatment significantly delayed the time to relapse of Alzheimer's agitation compared with placebo, with the risk of relapse with AXS-05 3.6 times less than with placebo. 8.4% of patients in the AXS-05 treatment arm experienced agitation relapse compared with 28.6% of patients in the placebo arm, showing that the drug was also significantly effective in prevention. AXS-05 treatment also significantly reduced the worsening of agitation compared with placebo. A major unmet need in the market is for treatments for the many secondary symptoms that can negatively impact patients' and caregivers' quality of life. Key opinion leaders (KOLs) previously interviewed by GlobalData highlighted agitation as a particularly distressing symptom with a lack of good treatment options. At the AD/PD 2025 International Conference on Alzheimer's and Parkinson's Diseases held in Vienna, Austria, in early April 2025, during a symposium sponsored by Bristol Myers Squibb that focused on the neuropsychiatric dimensions of Alzheimer's, the unmet need for the management of agitation was further highlighted. Up to 75% of patients can present with this issue and it is associated with a more rapid decline in cognition and function, resulting in increased risk of earlier patient institutionalisation and increased risk of mortality. Agitated patients are often prescribed antipsychotic medications and sedatives off-label to alleviate behavioural issues. The FDA states that this practice can be dangerous for the elderly. In 2023, Otsuka Pharmaceuticals' Rexulti (brexpiprazole) became the first FDA-approved treatment for agitation associated with Alzheimer's in the US, but KOLs felt that Rexulti's efficacy was only comparable to other atypical antipsychotics and thus did not provide a significant breakthrough for Alzheimer's agitation treatment. AXS-05's positive efficacy is therefore particularly significant, as it would provide a novel, non-antipsychotic treatment option if approved. AXS-05's novel mechanism of action was highlighted as promising for Alzheimer's agitation during the BMS AD/PD 2025 symposium, particularly when compared to Rexulti. Unfavourable opinion about the use of atypical antipsychotics for Alzheimer's agitation is chiefly due to their side-effect profiles. In ACCORD-2, AXS-05 was well tolerated, with no serious treatment-emergent adverse events (TEAEs) and no-one discontinuing the drug due to TEAEs. AXS-05 was also not associated with sedation or cognitive decline, and the overall safety profile is well established following its approval under the brand name Auvelity for major depressive disorder (MDD) in the US in 2022. Physician experience with Auvelity in MDD and its safety profile should give it a further competitive edge in the AD market. Other products in late-stage development for AD agitation are Suven Life Sciences's 5-hydroxytryptamine receptor 6 antagonist masupirdine and BioXcel Therapeutics' alpha 2 adrenergic receptor agonist Igalmi (dexmedetomidine). BMS's M1–M4 muscarinic agonist Cobenfy (trospium chloride + xanomeline tartrate), which is currently marketed for schizophrenia, is in the late-stage pipeline for psychosis associated with Alzheimer's, for which there are no approved drugs. While these products will begin to help meet the present need, both Axsome Therapeutics and BioXcel Therapeutics are currently focusing on development in the US only, so opportunity will remain outside the US. "AAN 2025: Axsome Therapeutics' treatment for Alzheimer's agitation shows promise" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
12-02-2025
- Business
- Yahoo
Why Axsome Therapeutics (AXSM) Is Advancing Today
Axsome Therapeutics (AXSM) is climbing nearly 4% after Swiss bank UBS increased its price target on the shares to $133 from $105. The bank is confident that the company's potential treatment for Alzheimer's Disease Agitation (ADA) will ultimately be approved by the FDA. UBS' Take on AXSM The bank expects the FDA to accept AXSM's filing of its potential ADA treatment, AXS-05, for the agency's approval, and UBS anticipates that the drug will ultimately be approved by the FDA for this indication. The drug hit its primary endpoints in three trials of its effectiveness as an ADA treatment and failed to meaningfully surpass the placebo in one such trial. AXS-05 is already approved as a treatment for major depressive disorder. UBS reports that there are only limited therapies for ADA at this point, and it kept a Buy rating on AXSM. AXSM Settled Patent Litigation The company disclosed yesterday that it had settled patent litigation with Teva (TEVA) related to AXSM's antidepressant drug, Auvelity. Teva was trying to receive authorization from the FDA to market a generic version of the drug before a number of AXSM's patents expire. Under the deal, Teva will not be allowed to market a generic version of the drug until 2038 or 2039. The settlement will be reviewed by the Department of Justice and the Federal Trade Commission. While we acknowledge the potential of AXSM, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than AXSM but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ ALSO 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock Disclosure: None. This article is originally published at Insider Monkey.
