Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
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
www.fda.gov/medwatch
.
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
AUVELITY.com
.
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
www.axsome.com
and follow us on
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@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
3 Dow Jones Dividend Stocks With Above-Average Yields You Can Buy Now and Hold for at Least a Decade
Key Points UnitedHealth Group's reduced profit forecast for 2025 is disappointing, but the health insurance business is in a good position to bounce back. Coca-Cola's dividend payout has risen for 63 consecutive years. Amgen sells over a dozen drugs that are growing sales at a double-digit annual percentage. 10 stocks we like better than UnitedHealth Group › Income-seeking investors who value their time know the best dividend stocks don't need a lot of babysitting. Some go on decades-long payout-raising streaks. The Dow Jones Industrial Average (DJINDICES: ^DJI) is one of the best places to find reliable dividend payers. Stocks aren't added to this exclusive list unless they have already demonstrated an ability to produce profits in good economic times and bad ones, too. The average dividend payer in the Dow Jones Industrial Average offers a measly 1.6% yield at recent prices. UnitedHealth Group (NYSE: UNH), Coca-Cola (NYSE: KO), and Amgen (NASDAQ: AMGN) stand out with above-average yields. Here's why they could be great additions to a long-term dividend investor's portfolio. 1. UnitedHealth Group Shares of UnitedHealth Group collapsed in May, after the company simultaneously suspended its 2025 outlook and announced an abrupt CEO exit. To top it off, the company felt it was necessary to issue responses to several Wall Street Journal articles and a Department of Justice investigation regarding its Medicare business. The stock is down, but its dividend payout is way up. The company raised it by 76.8% over the past five years. At its beaten-down price, the stock offers a 2.7% yield. Health insurance businesses operate on thin margins. It turns out that UnitedHealth mispriced premiums going into 2025. Healthcare providers are charging more than the company anticipated, plus the amount of care new members have been using is also higher than expected. Smart investors such as Warren Buffett know that UnitedHealth Group is mostly a middleman that can pass increased costs on to health plan sponsors. It may have mispriced premiums going into 2025, but this isn't a mistake its recently refreshed management team is likely to make again in the decade ahead. 2. Coca-Cola Unlike UnitedHealth, Coca-Cola stock is up near its all-time high. The soda giant's dividend hasn't risen as sharply as the health insurer's, but it's still up by 24.4% over the past five years. Being the only company that can sell many of the world's most popular beverage brands is a strong advantage that leads to consistent profits. In February, the company announced a dividend raise for the 63rd year in a row. Shares of Coca-Cola offer a 2.9% yield at recent prices, and another decade of significant dividend raises isn't an unreasonable expectation. Second-quarter unit case volume fell by 1%, but the strength of its brands allowed organic revenue to rise by 5% year over year. Sales of sugary sodas have been losing ground to sports drinks, but the company has this base covered. Its BodyArmor brand boasts a double-digit share of the U.S. market, and its older Powerade brand is even more popular. Adding some shares of this stock to a diverse portfolio is an almost certain way to boost your passive income stream over time. 3. Amgen Shares of biotechnology pioneer Amgen have been trading about 12% below the all-time high they set last year. Amgen began paying a dividend in 2011 and has been able to increase it every year since. The drugmaker raised its payout by 48.8% over the past five years. At recent prices, it offers a 3.2% yield. Two of Amgen's top revenue streams, Enbrel and Prolia, are drying up thanks to biosimilar competition. Fortunately, the losses are easily offset by a slew of more recently launched products. Amgen recently reported year-over-year sales increases at a double-digit percentage for 15 products in the second quarter. New competition for Enbrel and Prolia limited second-quarter sales growth to 9% year over year. Enbrel and Prolia losses will most likely reach a bottom long before Amgen's new growth drivers run out of fuel. With a strong lineup of new products, this company could report strong sales growth in the decade ahead. Should you buy stock in UnitedHealth Group right now? Before you buy stock in UnitedHealth Group, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and UnitedHealth Group 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 $671,466!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,115,633!* Now, it's worth noting Stock Advisor's total average return is 1,077% — a market-crushing outperformance compared to 185% 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 August 18, 2025 Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Amgen. The Motley Fool recommends UnitedHealth Group. The Motley Fool has a disclosure policy. 3 Dow Jones Dividend Stocks With Above-Average Yields You Can Buy Now and Hold for at Least a Decade was originally published by The Motley Fool
Yahoo
an hour ago
- Yahoo
Achieve Life Sciences Inches Closer To FDA Nod For First New Quit-Smoking Drug In 20 Years
Achieve Life Sciences Inc. (NASDAQ:ACHV) is moving closer to a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades, positioning the company for a high-stakes commercial launch in 2026. In a vote of confidence for the late-stage specialty pharmaceutical company's pipeline with a focus on smoking health and nicotine dependence, HC Wainwright has initiated coverage on Achieve Life Sciences with a Buy rating and a $12 price forecast. In June, Achieve Life Sciences submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline for nicotine dependence for smoking cessation in cytisinicline NDA is supported by a combination of efficacy and well-tolerated safety results from two Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation. In both studies, cytisinicline administered for 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and long-term abstinence through week 24 compared to placebo. The company has also included safety data on over 300 participants with at least six months of cumulative cytisinicline exposure. In June, the company raised around $45 million to fund continued advancement of cytisinicline through potential FDA marketing approval of cytisinicline and for working capital and general corporate purposes. The company expects the funding to provide runway into the second half of 2026. Analyst Brandon Folkes says, 'With the New Drug Application (NDA) now submitted, and a potential FDA approval and commercial launch in 2026, we view the next 12 to 18 months as a period of potential significant value inflection for ACHV stock.' Achieve Life Sciences' shares undervalue the commercial potential of cytisinicline, given the shortcomings of current therapies, rising smoking and vaping rates, and its superior efficacy and tolerability versus Pfizer Inc.'s (NYSE:PFE) Chantix (varenicline) and generics. Folkes sees tolerability as a key edge for cytisinicline, noting varenicline's side effects have limited its use. He argues that Achieve Life Sciences' valuation fails to capture the strong NDA data or the sizable market opportunity, where peak sales could far exceed the company's current worth. According to an investor note from Folkes, a rational pricing strategy for cytisinicline, potentially ranging from $500 to $3,000 per month, could be justified by the significant health economic costs associated with smoking. Cytisinicline could become the first FDA-approved smoking cessation therapy in nearly 20 years, with a U.S. launch expected in 2026. Its differentiated profile, flexible dosing, and broad adoption potential position it well in a $13 billion global market. Before its withdrawal, Pfizer's Chantix generated nearly $1 billion annually in U.S. sales, highlighting the sizable opportunity relative to Achieve's current valuation. Price Action: ACHV stock is trading higher by 14.92% to $2.97 at last check Thursday. Image via Shutterstock Latest Ratings for ACHV Date Firm Action From To Oct 2021 Alliance Global Partners Initiates Coverage On Buy Jun 2021 Oppenheimer Initiates Coverage On Outperform Sep 2020 Lake Street Initiates Coverage On Buy View More Analyst Ratings for ACHV View the Latest Analyst Ratings Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Achieve Life Sciences Inches Closer To FDA Nod For First New Quit-Smoking Drug In 20 Years originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
Yahoo
3 hours ago
- Yahoo
Applied StemCell Appoints Dolores Baksh, Ph.D., as Chief Executive Officer
Dolores Baksh, Ph.D. MILPITAS, Calif., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Applied StemCell, a genome engineering product and services company, announced today the appointment of Dolores Baksh, Ph.D., as Chief Executive Officer. Company founder and former CEO Ruby Tsai, Ph.D., will continue to guide scientific strategy, innovation, and strategic collaborations as President and Chief Scientific Officer (CSO). 'Dolores brings exactly the kind of leadership we need to help scale Applied StemCell,' said Dr. Tsai. 'Her deep experience in commercializing advanced therapies, combined with her ability to execute high growth-oriented strategies, makes her an ideal partner for our next phase of growth. I am excited to focus on the tremendous opportunity to advance Applied StemCell's proprietary genome engineering platforms to help accelerate the adoption of cell and gene therapies.' Dr. Baksh joins Applied StemCell with more than 20 years of leadership in the life sciences industry, including prior roles as founding CEO of Hyperius Biotech and CEO of TAAV Biomanufacturing Solutions. She has helped build and scale companies at the forefront of cell and gene therapy manufacturing, with a focus on enabling technologies that improve quality, reduce cost, and accelerate access for patients. 'I'm thrilled to join Applied StemCell at such a pivotal time,' said Dr. Baksh. 'Ruby and the team have built a remarkable foundation of innovation, and I look forward to helping amplify that legacy by expanding our commercial reach, accelerating new product development, and forging partnerships that translate scientific breakthroughs into real-world impact.' Applied StemCell is known for its proprietary TARGATT™ large knock-in technology, custom iPSC services, and GMP-compliant cell lines that support both research and therapeutic development. With Dr. Baksh's appointment, the company is poised to strengthen its position as a trusted partner to biopharma companies advancing next-generation therapies. About Applied StemCellFounded in 2008 to provide industry and academic researchers with the ability to leverage the power of gene editing and induced pluripotent stem cells (iPSC), Applied StemCell continues to use our innovative technologies to power the discovery and development of advanced therapeutics. With a focus on genome engineering products and services, our patented technologies ensure a clear IP path to commercialization. For media inquiries, please contact:Pia Abola, of MarketingApplied 457-1312 A photo accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
