Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
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
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
Fast Company
18 minutes ago
- Fast Company
Heartflow stock listing and IPO date draw near: AI-powered medtech aims for $1.3 billion valuation
It seems there's fresh blood pumping back into the IPO market. After a blowout initial public offering from Figma last week, investors might have another chance to get their heart rates up again soon. Heartflow, a California-based medtech company that utilizes AI with imaging and diagnostics software to help evaluate cardiac and coronary diseases, is looking to list shares on the Nasdaq. In paperwork filed on Friday with the Securities and Exchange Commission (SEC), Heartflow said it plans to offer 12.5 million shares, priced between $15 and $17. That could potentially raise more than $208 million. According to Reuters, Heartflow's target valuation could be as high as $1.3 billion. The company plans to trade under the ticker 'HTFL.' Subscribe to the Daily newsletter. Fast Company's trending stories delivered to you every day Privacy Policy | Fast Company Newsletters Personalized 3D-models of people's hearts Heartflow uses AI and other technology to scan patients for coronary and cardiac problems, creating three-dimensional models of patients' hearts. The Food and Drug Administration (FDA) gave the software the green light in 2022, and it's now being used in some markets to diagnose patients. Additionally, the company got a leg up last year when the U.S. Centers for Medicare and Medicaid Services (CMS) expanded Medicare coverage to include platforms that use imaging results to look for signs of coronary disease, and the American Medical Association (AMA) issued a new Category I CPT code for those platforms. That gives doctors and clinics the go-ahead to start using the technology on a broader scale starting next year. According to the company's SEC filing, Heartflow says that as of the end of March 2025, it's been used to assess more than 400,000 patients. Revenues are growing but profits are elusive Heartflow generated $125.8 million in 2024, a 44% increase over the $87.2 million it made the year before, the company says. Revenue likewise grew 39% for the first quarter of 2025 to $37.2 million. However, the company saw a net loss of $96.4 million in 2024, wider than its net loss of $95.7 million in 2023. It warns in the filing that it expects to incur 'substantial losses in the foreseeable future [and] may not be able to achieve or sustain profitability.' Bain Capital, Panorama Point Partners, and Capricorn Investment Group are among Heartflow's backers, according to Crunchbase. Bain led its most recent fundraising round, a Series F round in 2023, which raised $215 million. This is not the first time that Heartflow has attempted to go public. The company had planned to merge with a special purpose acquisition company during the SPAC frenzy of the early pandemic years, but it halted the plan in 2022, citing 'unfavorable market conditions,' as Fierce Biotech reported. Heartflow's IPO comes on the heels of another growing medtech company's public debut. Carlsmed, which specializes in AI-driven spine surgery technology, recently went public as well, with shares trading on July 23. Since then, the stock is down around 4.5%. Heartflow has not said when it plans to list its stock. Fast Company reached out for more details on the timeline and will update this post if we hear back.
UPI
an hour ago
- UPI
Rocket Lab launches Japanese radar satellite
Rocket lab launched a synthetic aperture radar satellite dubbed QPS-SAR-12 for the Japanese company IQS on Tuesday morning apart of a mission to build their constellation in low Earth Orbit. Photo courtesy of Rocket Lab Aug. 5 (UPI) -- Rocket Lab launched a synthetic aperture radar satellite dubbed QPS-SAR-12 for the Japanese company IQS on Tuesday morning, part of a mission to build its constellation in low Earth Orbit. The mission "The Harvest Goddess Thrives" lifted off from Rocket Lab's launch complex 1 at the New Zealand site at 12:10 a.m. EDT. The deployed satellite went into circular orbit 357 miles above Earth after about 54 minutes, Rocket Lab said on X. "Every Electron launch is a demonstration of payload deployment precision for our customers -- an especially critical element when scaling satellite constellations," Rocket Lab Founder and CEO Sir Peter Beck said in a press release. Today's fifth and flawless deployment for iQPS once again underscores Electron's reliability and continues to prove that consistent tailored access to space is a reality for Electron for our customers." "The data gathered by QPS-SAR constellation has the potential to revolutionize industries and reshape the future," Rocket Lab wrote in the mission's press release. "The Harvest Goddess Thrvies" is Rocket Lab's 11th Electron Mission this year and 69th launch overall.
San Francisco Chronicle
2 hours ago
- San Francisco Chronicle
Philippines condemns China's rocket launch after suspected debris sparked alarm
MANILA, Philippines (AP) — A top Philippine security official on Tuesday condemned China's latest rocket launch, which caused suspected debris to fall near a western Philippine province. Authorities said the incident sparked alarm and posed a danger to people, ships, and aircraft. There were no immediate reports of injuries or damage from the suspected Chinese rocket debris that fell near Palawan province Monday night, National Security Adviser Eduardo Año said. However, he added that these posed 'a clear danger and risk to land areas and to ships, aircraft, fishing boats and other vessels' near the expected drop zones. 'We condemn in no uncertain terms the irresponsible testing done by the People's Republic of China of its Long March 12 rocket which alarmed the public and placed the people of Palawan at risk,' Año said in a statement. People were alarmed after hearing loud explosions Monday night in Palawan's Puerto Princesa city and nearby towns, Año said, adding that 'local residents also saw a fireball cross the sky that later exploded causing the ground to shake.' Chinese officials did not immediately comment on Año's statement. China's official Xinhua News Agency reported that the Long March-12 rocket that lifted off Monday night from a commercial spacecraft launch site on the southern island province of Hainan successfully carried a group of internet satellites into pre-set orbit. It was the 587th mission by the Long March carrier rockets, Xinhua said, citing the launch site. It was not immediately clear if Chinese authorities notified nearby countries like the Philippines of possible debris from its latest rocket launch. The Philippine Space Agency said Monday that debris from the rocket launch was expected to have fallen within two identified drop zones about 21 nautical miles (39 kilometers) from Puerto Princesa City in Palawan and 18 nautical miles (33 kilometers) from Tubbataha Reef Natural Park, an area of coral reefs in the Sulu Sea off eastern Palawan that is popular among divers and conservators. 'Unburned debris from rockets, such as the booster and fairing, are designed to be discarded as the rocket enters outer space,' the space agency said. 'While not projected to fall on land features or inhabited areas, falling debris poses danger and potential risk to ships, aircraft, fishing boats and other vessels that will pass through the drop zone.' Philippine aircraft and vessels were deployed Tuesday to search for the rocket debris, Año said. He asked the public to notify authorities if they find any piece of debris but warned them not to touch them because of possible toxic fuel residues.
