Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
NEW YORK, June 11, 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 seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington.
Details for the presentations are as follows:
AXS-12
Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy
Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC
Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT
Poster Session: P-51
Poster Number: 405
Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
Oral Presentation Date and Time: Wednesday, June 11, 3:45 - 4 p.m. PT
Oral Session: O-24
Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT
Poster Session: P-51
Poster Number: 390
Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
Oral Presentation Date and Time: Wednesday, June 11, 4 - 4:15 p.m. PT
Oral Session: O-24
Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT
Poster Session: P-51
Poster Number: 391
Solriamfetol
Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT
Poster Session: P-50
Poster Number: 366
Title: Real-World Use of Solriamfetol for Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnea in the US
Lead Author: Yang Zhao, PhD, Axsome Therapeutics
Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT
Poster Session: P-50
Poster Number: 369
About AXS-12
AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA.
About Solriamfetol
Solriamfetol is a 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), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
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
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@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
2 hours ago
- Yahoo
Investors should consider this growth stock… it's SpaceX's competition
Rocket Lab (NASDAQ:RKLB) is a US-listed growth stock that gives investors rare access to the commercial space sector. As a vertically integrated launch and space systems provider, Rocket Lab is often compared to SpaceX in its ambition and capabilities. But there's one crucial difference: you can actually buy shares in Rocket Lab, while SpaceX remains private. Rocket Lab delivers launch services, builds small and medium-class rockets, and manufactures spacecraft components for a range of commercial, government, and defense customers. With rapid revenue growth, an impressive order book, and expansion into new markets, Rocket Lab offers public market investors a way to participate in the booming space economy. It targets many of the same opportunities as its more famous, privately held peer. Rocket Lab and SpaceX operate in the same commercial space sector but differ significantly in scale, maturity, and valuation. Rocket Lab's market cap is currently $12.85bn, with trailing 12 months (TTM) revenue of approximately $460m. Despite strong growth — revenue nearly doubled from $240m in 2023 — Rocket Lab remains a smaller, earlier-stage player focused on small to medium launch vehicles and spacecraft manufacturing. Its valuation multiples are extremely high, with a forward price-to-sales ratio of 22.3 times, reflecting investor optimism. SpaceX, by contrast, is a far more mature private company valued at about $350bn. It's projected to generate $15.5bn in revenue in 2025. This is driven by its dominant Falcon 9 launch services and rapidly growing Starlink satellite internet business. SpaceX's valuation implies roughly a 22.5 times multiple on forward revenue. This is broadly in line with Rocket Lab. Focusing on Rocket Lab, the company is projected to deliver rapid revenue growth over the next several years, with estimates rising from $573m in 2025 to $889 in 2026, $1.2bn in 2027, and $1.69bn in 2028. This represents annual growth rates consistently above 30%, and even a jump of nearly 77% in 2030. However, the number of analysts providing forecasts declines sharply after 2027, dropping from 11–14 analysts in the near term to just two or one by 2028 and 2030. The one analyst projecting as far as 2030 sees $4bn in revenue for the year. I had the chance to buy Rocket Lab shares at $15 just two months ago. I missed out as unfortunately my attention had been diverted elsewhere. However, I found another entry point. And personally, I see this as an investment to hold for a very long period. The space industry is still in its early innings, with enormous potential as satellite launches, lunar missions, and in-orbit services become increasingly mainstream. And like any investment, there are risks. Rocket Lab remains loss-making. It's expected to turn a profit in 2026, when it will trade at 620 times earnings. And while this moderates to 140 times in 2027, it's still expensive and introduces plenty of execution risk. However, I certainly believe UK investors should consider this one. It could be a real winner going forward. The post Investors should consider this growth stock… it's SpaceX's competition appeared first on The Motley Fool UK. More reading 5 Stocks For Trying To Build Wealth After 50 One Top Growth Stock from the Motley Fool James Fox has positions in Rocket Lab. The Motley Fool UK has no position in any of the shares mentioned. Views expressed on the companies mentioned in this article are those of the writer and therefore may differ from the official recommendations we make in our subscription services such as Share Advisor, Hidden Winners and Pro. Here at The Motley Fool we believe that considering a diverse range of insights makes us better investors. Motley Fool UK 2025 Sign in to access your portfolio
Business Upturn
3 hours ago
- Business Upturn
Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA
By GlobeNewswire Published on June 21, 2025, 04:38 IST Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy ® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo 1 (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo Safety and tolerability of the higher dose of Wegovy ® (semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) 1 (semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) The STEP UP data add to the existing evidence base on the value of Wegovy® in delivering significant weight loss and health gains for people living with obesity Bagsværd, Denmark, 21 June 2025 – Novo Nordisk today presented the results from the phase 3b STEP UP trial in people with obesity without diabetes at the American Diabetes Association (ADA) Scientific Sessions, in Chicago, US. In the STEP UP trial, the higher dose of Wegovy® (semaglutide 7.2 mg) demonstrated a mean weight loss of 21%, with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1 'The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide's established safety profile. This may offer another option to people who do not attain their weight goals,' said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. 'We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.' STEP UP co-primary endpoints at 72 weeks *1 : semaglutide 7.2 mg semaglutide 2.4 mg PlaceboWeight loss 20.7% 17.5% 2.4% 5% or more weight loss 93.2% 92.5% 35.7% When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo. 'With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. This includes maximising the value of semaglutide for individuals, healthcare systems and society, and developing a new oral formulation of Wegovy® that, pending FDA approval, can become the first GLP-1 pill to offer double-digit weight loss.' In the STEP UP trial, semaglutide 7.2 mg demonstrated a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.1 The most common adverse events were gastrointestinal, and the vast majority were mild to moderate during dose escalation and diminished over time, consistent with the GLP-1 class.1 In STEP UP, 3.3% of people treated with semaglutide 7.2 mg discontinued due to gastrointestinal adverse events, compared to 2.0% with semaglutide 2.4 mg and 0% with placebo.1 Novo Nordisk expects to file the higher dose of Wegovy® for a label update in the EU in the second half of 2025, followed by regulatory submissions in other markets where Wegovy® is already approved. STEP UP selected confirmatory secondary endpoints at 72 weeks * 1 : semaglutide 7.2 mg semaglutide 2.4 mg Placebo10% or more weight loss 86.0% 77.6% 20.0%15% or more weight loss 70.4% 57.5% 7.9%20% or more weight loss 50.9% 35.1% 2.9% 25% or more weight loss 33.2% 16.7% 0% * Based on the trial product estimand: treatment effect if all people adhered to treatment. About the STEP UP trials Novo Nordisk has completed two trials, STEP UP and STEP UP T2D, investigating the efficacy and safety of semaglutide 7.2 mg in people with obesity with or without type 2 diabetes. The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy and safety of semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included 1,407 adults with a BMI ≥30 kg/m2 without diabetes. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key confirmatory secondary endpoints included the number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively. The 72-week STEP UP T2D trial investigated semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. About Wegovy® Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis. In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References Wharton, S, et al. (2025). Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. 1966-LB poster. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025.17. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Upturn
3 hours ago
- Business Upturn
ImpactLife shares highlights from World Sickle Cell Disease Awareness Day event
Davenport, Iowa, June 20, 2025 (GLOBE NEWSWIRE) — ImpactLife hosted a special event at its Davenport, Iowa headquarters to recognize World Sickle Cell Disease Awareness Day as part of local celebrations of the Juneteenth federal holiday. The Juneteenth holiday — commemorating the emancipation of enslaved people in the United States — is also recognized as World Sickle Cell Awareness Day with the goal to increase public knowledge of sickle cell disease and the challenges experienced by patients and caregivers. Community members and blood center employees gathered on Thursday, June 19, to learn about the importance of blood transfusions in providing supportive care for sickle cell patients and to hear personal experiences from those who live with sickle cell disease, or who have lost loved ones to the genetically inherited blood disorder. Speakers included Beleta Rush, who shared writings and experiences from the lives of her two daughters, Lynn and Bobbie. View and download video clips from the event, below, or on the ImpactLife web site. Dr. Meredith Parsons, Clinical Assistant Professor of Pathology from University of Iowa, provided an overview on sickle cell disease, how it affects patients, and the importance of having appropriately matched units of blood available for patients who are likely to receive multiple rounds of blood transfusions throughout their lives. Shyneeta Rush, Supervisor, Donor Services, described the blood center's Red4Life program and efforts by the blood center to identify donors who are an appropriate match for sickle cell disease patients. Cheryl Easley, of the ImpactLife donor scheduling team, helped organize the event, and recognized sickle cell 'Warriors In Battle' as well as 'Winged Warriors,' who have passed after living with the disease throughout their lives. Lamour Bluitt has two sisters living with sickle cell disease, and has authored a book on their experiences, A Child Born with Sickle Cell: the Untold Secret. About Sickle Cell Disease Sickle dell disease is an inherited blood disorder that affects red blood cells. It is the most common hereditary disorder and currently affects more than 100,000 Americans, predominantly people of African descent. The red blood cells in patients with sickle cell disease can become 'sickled' in shape, which can cause the cells to become stuck in small blood vessels. Patients can experience pain and anemia and are at increased risk for strokes and other types of organ damage. When patients experience a sickle cell crisis, red cell transfusion is a major form of therapy to relieve symptoms. Patients with sickle cell disease frequently receive transfusions of red blood cells to help treat symptoms of a sickle cell crisis. But finding appropriately matched units for sickle cell disease patients is a challenge for blood providers. With more frequent blood transfusions, patients with sickle cell disease can develop antibodies that are directed against red blood cell antigens. This process, called alloimmunization, makes it important for patients to receive antigen-negative blood types that are more generally found in donors of African descent. To help increase the diversity of the blood center's donor base, ImpactLife has created a donor program called Red4Life. Under Red4Life, the blood center identifies and recruits donors who may be an appropriate antigen match for patients with sickle cell disease. These donors are then invited to join the Red4Life program and receive special donor rewards and additional points to use in the ImpactLife Donor Loyalty Store. (Learn more at About ImpactLife ImpactLife's mission is to save lives by engaging donors, supporting partners, and advancing medicine. Founded in 1974, ImpactLife supplies blood products and services to hundreds of hospitals, emergency services organizations, clinical researchers, and other blood centers throughout Iowa, Illinois, Wisconsin, and Missouri. The nonprofit blood provider is ranked among the leading 12 blood suppliers in the United States. For more information on current blood inventory levels, our donor promotions, and more, see and find us @impactlifeblood on Facebook, X, Instagram, Threads, YouTube, and LinkedIn. Attachments Beleta Rush ImpactLife – World Sickle Cell Disease Awareness Day group photo Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
