Jazz Pharmaceuticals presents late-breaking phase 4 data showcasing Xywav
Jazz Pharmaceuticals (JAZZ) 'announced late-breaking Phase 4 data evaluating treatment benefits of Xywav oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies. Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.'
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Medscape
13-06-2025
- Medscape
Daytime Sleepiness Tied to Risk for Early Death in Women
SEATTLE — Excessive daytime sleepiness (EDS) was associated with a significantly increased risk for all-cause mortality in women, results of a large observational study showed. After adjusting for health and demographic factors, women aged 50 and 65 years with high scores on the Epworth Sleepiness Scale (ESS) were 16% more likely to die from any cause than their counterparts who had normal levels of sleepiness on this tool. This association was not found in younger women or in those over age 65 years. 'Identifying middle age as a critical period suggests clinicians should prioritize an Epworth Sleepiness Scale assessment and excessive daytime sleepiness management in women approaching their 50s and early 60s,' lead author Arash Maghsoudi, PhD, with Baylor College of Medicine in Houston, said in a news release. The findings were presented on June 9 at SLEEP 2025. Data Gap in Women EDS has been associated with all-cause mortality in previous studies, which primarily focused on men. Maghsoudi and colleagues analyzed the medical records of 40,250 female veterans (mean age, 48 years) from 1999 to 2022, focusing on individuals with sleep-related International Classification of Diseases, 9th/10th Revision codes, or those who had received clinical sleep services. They used a validated natural language processing tool to extract ESS scores from clinical notes, with scores categorized as normal (0-10) or high (11-24). Participants were further stratified into three age groups: Young (< 50 years), middle-aged (≥ 50 to < 65 years), and older adults (≥ 65 years). The results were adjusted for age, race, ethnicity, BMI, and Charlson Comorbidity Index. In the overall cohort, the adjusted odds ratio for all-cause mortality in those with high ESS scores compared to those with normal ESS scores was not statistically significant. However, when stratified by age, middle-aged women with high ESS scores had a significantly higher likelihood of all-cause mortality (adjusted odds ratio, 1.16), with no significant associations seen in the younger or older age groups. The researchers said further studies are needed to explore potential mechanisms, including sex-specific responses to sleepiness and the role of age in this association. 'Intriguing' Data Commenting on this research for Medscape Medical News , Indira Gurubhagavatula, MD, MPH, director of the Sleep Medicine Fellowship and professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia, said the finding that subjectively reported EDS in middle-aged women is associated with mortality strengthens the American Academy of Sleep Medicine (AASM) position that 'sleepiness matters.' The AASM recently published a position statement highlighting how sleepiness can interfere with daily functioning and serve as a marker for other conditions such as mental health problems, sleep disorders, or side effects of medications, as previously reported by Medscape Medical News . 'For these reasons, it is important for clinicians to ask their patients about sleepiness,' said Gurubhagavatula, a spokesperson for AASM. 'The Epworth Sleepiness Scale is a method to get quick, subjective responses and can help guide next steps in clinical evaluation. Improving sleepiness by treating the underlying cause can help restore daytime functioning at home and work, reduce risks of chronic health conditions, and improve people's quality of life,' Gurubhagavatula said. She noted that mechanistic reasons for the relationship between sleepiness and mortality in middle-aged women remain unknown. 'We need more studies to investigate the causal factors that would explain why this association exists,' she added. That said, 'the adjusted odds ratio is just above 1 (average 1.16) in the middle age group. If this is confirmed to be true, even though the risk seems small at an individual level, when you consider it across an entire population, the risk burden to society may be significant,' Gurubhagavatula told Medscape Medical News . She also cautioned that the study involved women veterans, whose risks for sleepiness and mortality may be different than those in other populations. Moreover, the results may not necessarily generalize to other groups. 'The bottom line is that the report is intriguing and calls for more studies to confirm this finding and help explain the mechanism,' Gurubhagavatula concluded.
Yahoo
12-06-2025
- Yahoo
Jazz Pharmaceuticals Releases Unexpected Phase 4 Results Highlighting Xywav®
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is one of the 13 Biotech Stocks with Huge Upside Potential. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is one of the stocks with the biggest upside. It presented late-breaking Phase 4 data on Xywav® at SLEEP 2025, which included findings from the XYLO and DUET trials. A biopharmaceutical scientist in their lab, studying a newly-diagnosed therapy-related acute myeloid leukemia. . In the XYLO study (n=43), moving from high-sodium to low-sodium oxybate resulted in a substantial decrease in 24-hour ambulatory systolic blood pressure (−4.1 mmHg; P=0.0019). SBP reduction during the day (−5.1 mmHg; P=0.0003) and while seated (−9.2 mmHg; P<0.0001) were secondary objectives. The TEAEs were moderate or mild. DUET data from 24 subjects taking 9-12g Xywav nightly displayed improvement in excessive daytime sleepiness and narcolepsy severity with an average dose of 11.2g during the stable period. Xywav is the sole FDA-approved low-sodium oxybate for cataplexy or EDS in narcolepsy and idiopathic hypersomnia. Xywav reduces nightly sodium intake by up to 92% compared to Xyrem®, lowering cardiovascular risk, which is a serious issue in narcolepsy patients. Both indications were awarded Orphan Drug Exclusivity by the FDA. Jazz Pharmaceuticals plc (NASDAQ:JAZZ)'s data underscores how crucial it is to lower sodium intake in long-term sleep disorder treatment plans. While we acknowledge the potential of JAZZ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error 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
Hamilton Spectator
11-06-2025
- Hamilton Spectator
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 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@
