Latest news with #AxsomeTherapeutics
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@
Business Insider
19-05-2025
- Business
- Business Insider
Analysts Conflicted on These Healthcare Names: Axsome Therapeutics (AXSM), Waters (WAT) and Cingulate Inc (CING)
Analysts have been eager to weigh in on the Healthcare sector with new ratings on Axsome Therapeutics (AXSM – Research Report), Waters (WAT – Research Report) and Cingulate Inc (CING – Research Report). Confident Investing Starts Here: Axsome Therapeutics (AXSM) In a report issued on May 16, Vikram Purohit from Morgan Stanley maintained a Buy rating on Axsome Therapeutics, with a price target of $190.00. The company's shares closed last Friday at $107.53. According to Purohit 's ranking currently consits of 0 on a 0-5 ranking scale, with an average return of -7.5% and a 30.9% success rate. Purohit covers the Healthcare sector, focusing on stocks such as Recursion Pharmaceuticals, BioMarin Pharmaceutical, and Arcutis Biotherapeutics. Currently, the analyst consensus on Axsome Therapeutics is a Strong Buy with an average price target of $177.85, a 66.6% upside from current levels. In a report issued on May 1, Mizuho Securities also maintained a Buy rating on the stock with a $210.00 price target. Waters (WAT) Bank of America Securities analyst Michael Ryskin reiterated a Hold rating on Waters yesterday and set a price target of $370.00. The company's shares closed last Friday at $359.48. According to Ryskin is a 2-star analyst with an average return of 0.2% and a 45.0% success rate. Ryskin covers the Healthcare sector, focusing on stocks such as Maravai Lifesciences Holdings, West Pharmaceutical Services, and Fortrea Holdings Inc. The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Waters with a $393.77 average price target, representing an 11.9% upside. In a report issued on May 6, TD Cowen also maintained a Hold rating on the stock with a $375.00 price target. Cingulate Inc (CING) In a report released yesterday, Boobalan Pachaiyappan from Roth MKM reiterated a Buy rating on Cingulate Inc, with a price target of $11.00. The company's shares closed last Friday at $3.82, close to its 52-week low of $1.80. According to Pachaiyappan has 0 stars on 0-5 stars ranking scale with an average return of -9.8% and a 31.5% success rate. Pachaiyappan covers the Healthcare sector, focusing on stocks such as Reviva Pharmaceuticals Holdings, Entrada Therapeutics Inc, and Gain Therapeutics.
Globe and Mail
15-05-2025
- Health
- Globe and Mail
Non-Postoperative Acute Pain Market Poised for Significant Expansion by 2034, Amid FDA Approvals and Innovative Therapeutic Pipeline
The non-postoperative acute pain treatment market is positioned for substantial growth, driven by a strategic shift from traditional opioid therapies to advanced multimodal analgesia approaches and novel treatment options. Key pharmaceutical companies, including Vertex Pharmaceuticals, H. Lundbeck, Satsuma Pharmaceuticals, Axsome Therapeutics, Allodynic Therapeutics, and others, are spearheading innovation to address the significant unmet needs in non-postoperative acute pain management. DelveInsight's report titled " Non-Postoperative Acute Pain Market Insight, Epidemiology, and Market Forecast - 2034" provides a thorough analysis of trends in the non-postoperative acute pain market. It covers market drivers and challenges, historical and projected epidemiology, the current treatment landscape, and emerging therapies across the 7MM, which include the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The non-postoperative acute pain market size in the 7MM was valued at USD 3.6 billion in 2023, with significant growth expected at a notable CAGR during the forecast period (2024-2034). This growth is primarily fueled by rising prevalence, enhanced diagnostic capabilities, and the introduction of novel therapeutic options. Download the Non-Postoperative Acute Pain Market Forecast Report to understand which factors are driving the Non-Postoperative Acute Pain market @ Non-Postoperative Acute Pain Market Trends. The US represents the largest share of the non-postoperative acute pain market, with approximately 50 million incident cases reported in 2023. Epidemiological data reveal that moderate to severe cases contributed approximately 60% to the total diagnosed cases in the 7MM. Furthermore, pain cases related to migraine and cluster headaches constituted approximately 40% of total diagnosed cases in 2023 in the US, highlighting the significant burden of headache disorders within the acute pain spectrum. Discover evolving trends in the Non-Postoperative Acute Pain patient pool forecasts @ Non-Postoperative Acute Pain Epidemiological Analysis. The current non-postoperative acute pain treatment paradigm has undergone substantial transformation in recent years, with a notable shift away from opioid-based therapies toward multimodal analgesia (MMA) models. NSAIDs continue to play a crucial role in pain management, recognized for their ability to decrease opioid consumption by approximately 50%, positioning them as first-line medications for mild-to-moderate pain. Despite the availability of numerous generic NSAIDs following patent expirations, branded innovations continue to emerge, offering improved delivery systems and enhanced efficacy profiles. Among the recently approved medications, ELYXYB (celecoxib) by Scilex Holding (NASDAQ: SCLX) represents a breakthrough as the first and only ready-to-use oral solution designed for fast and long-lasting migraine relief with COX-2 selectivity. Other significant market entrants include ZAVZPRET (zavegepant) by Pfizer (NYSE: PFE), the first calcitonin gene-related peptide (CGRP) receptor antagonist available as a nasal spray, and NURTEC ODT by Pfizer/Biohaven Pharmaceutical (NYSE: BHVN), expanding treatment options for patients suffering from acute migraines. Furthermore, in January 2025, SYMBRAVO (AXS-07) was approved by the FDA for the acute treatment of migraine with or without aura in adults. The drug is a novel oral, rapidly-absorbed, multi-mechanistic investigational medicine combining MoSEIC meloxicam and rizatriptan for the acute treatment of migraine, with patent protection extending to 2036. The non-postoperative acute pain therapeutic pipeline shows significant promise, with several advanced candidates in late-stage development. VYEPTI (eptinezumab) by H. Lundbeck A/S (CPH: HLUN-B), a monoclonal immunoglobulin G1 antibody that specifically binds to human calcitonin gene-related peptide, is currently in Phase III development for cluster headache following its FDA approval for migraine prevention in adults in February 2020. Satsuma Pharmaceuticals (NASDAQ: STSA) is developing STS101, a dihydroergotamine nasal powder, which has demonstrated significant efficacy in providing sustained pain freedom and reduced need for rescue medication. Other notable pipeline candidates include Naltrexone Cetaminophen by Allodynic Therapeutics, further diversifying the therapeutic landscape Discover evolving trends in the Non-Postoperative Acute Pain treatment landscape @ Non-Postoperative Acute Pain Recent Developments. According to DelveInsight's specialists in the field, emerging therapies like STS101 DHE nasal powder have shown significant effectiveness in providing sustained pain relief with lower rescue medication requirements. The FDA's approval of therapies like EMGALITY for reducing the frequency of episodic cluster headache attacks represents a milestone in addressing previously undertreated acute pain conditions. These developments signal a positive trajectory for patients seeking more effective and targeted pain relief options. Despite therapeutic advances, challenges remain in the non-postoperative acute pain landscape, including the need for improved diagnostic accuracy, personalized treatment approaches, and enhanced accessibility to innovative therapies. As the field continues to evolve, increasing focus on biomarker-guided therapy selection and integration of non-pharmacological approaches alongside pharmaceutical interventions will likely reshape treatment strategies, offering improved outcomes for the millions affected by acute pain conditions worldwide. The integration of emerging digital health technologies and improved understanding of pain neurobiology is expected to further revolutionize acute pain management, moving toward more personalized, effective, and safer treatment paradigms that significantly enhance patient quality of life while minimizing the risks associated with traditional pain management approaches. Table of Contents 1. Key Insights 2. Executive Summary of Non-Postoperative Acute Pain 3. Non-Postoperative Acute Pain Competitive Intelligence 4. Non-Postoperative Acute Pain: Market Overview at a Glance 5. Non-Postoperative Acute Pain: Disease Background and Overview 6. Patient Journey 7. Non-Postoperative Acute Pain Epidemiology and Patient Population 8. Treatment Algorithm, Current Treatment, and Medical Practices 9. Non-Postoperative Acute Pain Unmet Needs 10. Key Endpoints of Non-Postoperative Acute Pain Treatment 11. Non-Postoperative Acute Pain Marketed Products 12. Non-Postoperative Acute Pain Emerging Therapies 13. Non-Postoperative Acute Pain: Seven Major Market Analysis 14. Attribute analysis 15. 7MM: Market Outlook 16. Access and Reimbursement Overview of Non-Postoperative Acute Pain 17. KOL Views 18. Non-Postoperative Acute Pain Market Drivers 19. Non-Postoperative Acute Pain Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Medscape
15-05-2025
- Health
- Medscape
FDA Approves Self-Administered Migraine Treatment
(Reuters) -The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals' self-administered migraine drug, giving way to a quick and more convenient treatment option for patients. The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday. Migraine, characterized by recurrent attacks of throbbing pain on one side of the head, causes symptoms such as nausea, vomiting and sensitivity to light. The treatment offers a beneficial alternative to those who respond poorly to oral therapies, Amneal said. Oral migraine treatments include Axsome Therapeutics' recently approved Symbravo and Pfizer's Nurtec ODT. Pfizer also sells a nasal spray, Zavzpret, for the treatment of acute migraine. Amneal's single-dose drug can be administered by patients into the middle of the thigh and does not require refrigeration or assembly of the device. Brekiya will be available in the U.S. by the second half of the year and Amneal will disclose price details close to the launch, it said. The FDA had previously declined to approve the application citing issues at a third-party manufacturing site. The company said last year it had transferred production to an in-house facility. (Reporting by Mariam Sunny and Puyaan Singh in Bengaluru; Editing by Devika Syamnath)
Globe and Mail
15-05-2025
- Business
- Globe and Mail
Is Axsome Therapeutics Stock Worth the Risk? A Comprehensive Analysis
Explore the exciting world of Axsome Therapeutics (NASDAQ: AXSM) with our expert analysts in this Motley Fool Scoreboard episode. Check out the video below to gain valuable insights into market trends and potential investment opportunities! *Stock prices used were the prices of April 9, 2025. The video was published on May 14, 2025. Should you invest $1,000 in Axsome Therapeutics right now? Before you buy stock in Axsome Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Axsome Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $613,951!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $796,353!* Now, it's worth noting Stock Advisor 's total average return is948% — a market-crushing outperformance compared to170%for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of May 12, 2025
