Latest news with #AXS-12
Hamilton Spectator
3 days ago
- Health
- 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@
Yahoo
16-02-2025
- Business
- Yahoo
This Stock Is Already Up by 55% in 2025: Is It Too Late to Buy?
It's only mid-February, but as of this writing biotech company Axsome Therapeutics (NASDAQ: AXSM) is up by 55% year to date. Substantial stock-market gains over short periods aren't that rare in the industry. For those who missed Axsome's rally this year, the question is whether the company can perform well over the long run. If that's the case, its shares might still be worth investing in even after their rise. Let's find out whether there's more upside ahead for Axsome Therapeutics. Let's start with a development that recently sent Axsome's stock soaring by about 25% in one day. The company settled a patent lawsuit related to Auvelity, a medicine for major depressive disorder (MDD), with generic drugmaker Teva Pharmaceutical Industries. Auvelity was first approved in 2022; it's one of only three medicines Axsome has on the market. If Teva had launched a generic version of Auvelity, that would have been a significant headwind for Axsome and completely altered its prospects. Fortunately, Teva's settlement with Axsome now means the former won't be able to launch a generic version of Auvelity until 2038 at the earliest. Axsome will grant Teva a license to launch an Auvelity generic at that point, but it's still 13 or more years away. That's excellent news for Axsome Therapeutics and its shareholders. Besides Auvelity, Axsome's lineup features a treatment for narcolepsy, Sunosi, and the newly approved therapy for migraine, Symbravo. Sunosi and Auvelity are driving strong revenue growth. While Axsome has yet to release its fourth-quarter and full-year 2024 financial results, it gave investors a sneak peek. It expects product revenue of $385.2 million for 2024, compared to total revenue of $270.6 million reported last year. So Axsome's 2024 top line should grow by at least 42% compared to 2023. The addition of Symbravo will make an impact on financial results this year. Moreover, the company should make clinical and regulatory progress. It plans to submit Auvelity to the U.S. Food and Drug Administration (FDA) as a potential treatment for Alzheimer's disease (AD) agitation in the second half of the year. In December, Axsome released data from two phase 3 clinical trials from its lead medicine in this indication; Auvelity hit its primary endpoint in the first study but missed it in the second. However, considering there's a high unmet need in AD -- and very few treatments for the disease have been approved in the past two decades -- there's still an excellent chance the FDA will give the go-ahead. Also in December, Axsome reported that an investigational medicine called AXS-12 aced a phase 3 study in treating narcolepsy. The FDA granted AXS-12 its orphan drug designation, which helps expedite the development of promising medications for orphan diseases (life-threatening conditions that affect fewer than 200,000 people in the U.S.). So the company will move forward with AXS-12, too. Elsewhere, Axsome expects late-stage clinical trial results for Sunosi in MDD and attention-deficit/hyperactivity disorder (ADHD) in the first quarter of 2025. It's also working on the submission of a regulatory application for AXS-14 in fibromyalgia. Axsome could launch at least one product and earn a key indication for another (Auvelity) in the next 18 months. In the next three years, it could have two other brand-new medicines in its portfolio on top of that. These drugs will drive solid top-line growth well into the 2030s. In my view, Axsome Therapeutics has yet to peak. The biotech company could deliver solid returns in the next five years and beyond, so it's not too late to invest in the stock. Ever feel like you missed the boat in buying the most successful stocks? Then you'll want to hear this. On rare occasions, our expert team of analysts issues a 'Double Down' stock recommendation for companies that they think are about to pop. If you're worried you've already missed your chance to invest, now is the best time to buy before it's too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you'd have $360,040!* Apple: if you invested $1,000 when we doubled down in 2008, you'd have $46,374!* Netflix: if you invested $1,000 when we doubled down in 2004, you'd have $570,894!* Right now, we're issuing 'Double Down' alerts for three incredible companies, and there may not be another chance like this anytime soon.*Stock Advisor returns as of February 3, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Axsome Therapeutics. The Motley Fool has a disclosure policy. This Stock Is Already Up by 55% in 2025: Is It Too Late to Buy? was originally published by The Motley Fool Sign in to access your portfolio
