Latest news with #AUVELITY
Hamilton Spectator
3 days ago
- Health
- Hamilton Spectator
Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
NEW YORK, May 28, 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 presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona. Details of the presentations are as follows: AUVELITY Title: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY®) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations Lead Author: Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the University of Virginia Presentation Date and Time: Wednesday, May 28, 11:15 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session I Poster Number: W25 AXS-05 Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized-Withdrawal Double-Blind Placebo-Controlled Study Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T16 Solriamfetol Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at Witten/Herdecke University, Germany Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T15 About AUVELITY® AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of AUVELITY in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if AUVELITY is safe and effective for use in children. AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? AUVELITY and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: Do not take AUVELITY if you: AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY. Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. Symptoms may include: Unusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). AUVELITY may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. AUVELITY may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: COMMON SIDE EFFECTS The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating. These are not all the possible side effects of AUVELITY. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . BEFORE USING Tell your HCP about all your medical conditions, including if you: Review the list below with your HCP. AUVELITY may not be right for you if: HOW TO TAKE LEARN MORE For more information about AUVELITY, call 866-496-2976 or visit . This summary provides basic information about AUVELITY but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about AUVELITY and how to take it. Your HCP is the best person to help you decide if AUVELITY is right for you. AUV CON BS 10/2022 Please see full Prescribing Information , including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide . 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 Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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@
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
01-03-2025
- Business
- Yahoo
Why Axsome Therapeutics, Inc. (AXSM) is Skyrocketing So Far in 2025
We recently published an article titled . In this article, we are going to take a look at where Axsome Therapeutics, Inc. (NASDAQ:AXSM) stands against the other biotech stocks. No matter the market environment, you'll always find entertainment in the biotech space. There will always be biotech stocks making huge swings in both directions and these stocks can make or break your portfolio in a very small amount of time due to the nature of how important clinical trial results are for these companies. The United Nations forecasts that the over-65 age group will grow by 150% from 800 million in 2024 to 2 billion by 2067. This "older, richer & sicker" population is expected to push global healthcare spending on medicines up 12% to $2.3 trillion by 2028. If you combine that with AI making breakthroughs in healthcare more frequent, you'll see many more biotech stocks starting to pop to the upside over the coming years. For this article, I screened the top-performing biotech stocks year-to-date. I will also mention the number of hedge fund investors in these stocks. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine. Number of Hedge Fund Holders In Q4 2024: 44 Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biopharmaceutical company that makes treatments for CNS disorders that don't have reliable alternative treatments. The stock is up significantly so far in 2025 due to the settlement of patent litigation with Teva Pharmaceuticals regarding AUVELITY, their treatment for major depressive disorder. This agreement prevents Teva from launching a generic version until at least September 2038 (or March 2039 if pediatric exclusivity is granted). Another major catalyst was the FDA approval of SYMBRAVO for the acute treatment of migraine with or without aura in adults. This was announced in early 2025. The company also has positive Phase 3 clinical trials for two key pipeline candidates for Alzheimer's and narcolepsy. The consensus price target of $165.36 implies 30.81% upside. Axsome Therapeutics, Inc. (NASDAQ:AXSM) is up 49.39% year-to-date. Overall AXSM ranks 13th on our list of the biotech stocks that are skyrocketing so far in 2025. While we acknowledge the potential of AXSM as an investment, 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 . READ NEXT: Why These 15 E-Commerce Stocks Are Skyrocketing So Far In 2025 and Disclosure: None. This article is originally published at Insider Monkey.
