Axsome Therapeutics Presents New Data Highlighting its Innovative Sleep Medicine Portfolio at SLEEP 2026

Rhea-AI Summary

Axsome Therapeutics (NASDAQ: AXSM) is presenting new data on its sleep medicine portfolio at SLEEP 2026 in Baltimore. Posters cover AXS-12 in narcolepsy with cataplexy, solriamfetol for excessive daytime sleepiness in narcolepsy and OSA, and symptom burden and quality of life in narcolepsy.

News Market Reaction – AXSM

-0.69%

-0.69% Session close to close

In the Jun 15 session, AXSM declined 0.69%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights Axsome’s expanding sleep-medicine footprint, with Phase 3 ENCORE data f...

Analysis

This announcement highlights Axsome’s expanding sleep-medicine footprint, with Phase 3 ENCORE data for AXS-12 in narcolepsy with cataplexy and solriamfetol analyses in narcolepsy and obstructive sleep apnea. It follows recent AUVELITY, SUNOSI, and migraine data, underscoring a steady cadence of CNS updates. Investors may watch for detailed efficacy and functional outcomes from these Phase 3 studies and survey findings on residual cataplexy symptom burden and quality of life.

Key Figures

Conference dates: June 14–17, 2026 Annual meeting number: 40th annual Session time: 10:00–11:45 a.m. ET +5 more

8 metrics

Conference dates June 14–17, 2026 SLEEP 2026 APSS annual meeting dates

Annual meeting number 40th annual 40th annual meeting of APSS (SLEEP 2026)

Session time 10:00–11:45 a.m. ET AXS-12 and solriamfetol presentations on June 15

Poster number 375 AXS-12 ENCORE trial poster at SLEEP 2026

Poster number 386 Solriamfetol narcolepsy and OSA Phase 3 analysis poster

Poster number 316 CRESCENDO survey residual cataplexy quality-of-life poster

Trial phase Phase 3 ENCORE trial of AXS-12 in narcolepsy with cataplexy

Annual meeting year 2026 SLEEP 2026 and associated presentations

Historical Context

5 past events · Latest: Jun 04 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 04	Migraine data presentations	Neutral	-0.9%	New SYMBRAVO migraine Phase 3 analyses at AHS scientific meeting.
Jun 03	Patent litigation settlement	Positive	+5.1%	Settlement resolving all U.S. SUNOSI patent litigation with generics.
Jun 01	Awareness partnership	Neutral	-1.8%	Migraine awareness initiatives and campaign support during awareness month.
May 27	Investor conferences	Neutral	+0.1%	Participation in multiple June investor conferences and webcasts.
May 26	Depression/sleep data	Neutral	-0.8%	AUVELITY and solriamfetol data presentations at ASCP 2026 meeting.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news has largely centered on data presentations, legal resolutions, and conferences, with mostly modest single-day price reactions.

Recent Company History

Over the past few weeks, Axsome has released multiple updates featuring new clinical data and corporate activities. On May 26, it highlighted AUVELITY and solriamfetol data at the ASCP 2026 meeting. Subsequent headlines covered investor conference participation on May 27, advocacy and awareness partnerships on June 1, and a SUNOSI patent litigation settlement on June 3. On June 4, Axsome presented new SYMBRAVO migraine data. Today’s SLEEP 2026 presentations on AXS-12 and solriamfetol fit this ongoing pattern of frequent CNS and sleep-related data disclosures.

Key Terms

phase 3, open-label extension, randomized-withdrawal, post-hoc, +4 more

8 terms

phase 3 medical

"Cognitive and Functional Outcomes from the Phase 3 Open-Label Extension..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

open-label extension medical

"Outcomes from the Phase 3 Open-Label Extension and Randomized-Withdrawal ENCORE..."

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

randomized-withdrawal medical

"Phase 3 Open-Label Extension and Randomized-Withdrawal ENCORE Trial of AXS-12..."

A randomized-withdrawal design is a clinical trial method where patients who show benefit from a treatment are first kept on it, then randomly assigned either to continue the treatment or to stop (often switching to a placebo) to see whether the benefit persists. For investors, this reveals how durable a drug’s effects and safety profile are over time—similar to checking whether a repaired appliance keeps working when you remove the new part—which affects regulatory approval, labeling, market demand and revenue forecasts.

post-hoc medical

"Post-hoc Multi-dimensional Composite Endpoint Analysis of Phase 3 Trials"

An observation or analysis done after an event has already happened, often looking for patterns or explanations that were not planned in advance. For investors, post-hoc conclusions can highlight possible causes of a stock move or trial result, but they can also be misleading because they may fit a story to the outcome rather than predict it—like drawing a target around an arrow after it hits the wall.

composite endpoint medical

"Post-hoc Multi-dimensional Composite Endpoint Analysis of Phase 3 Trials"

A composite endpoint is a single result used in clinical studies that combines several different outcomes—such as hospitalization, disease progression, or death—into one measure. For investors, it matters because bundling outcomes can change how a trial’s success looks: it can make a treatment appear more or less effective depending on which events are included, so it affects regulatory chances, market expectations, and the perceived commercial value of a therapy. Think of it as averaging multiple exam scores into one final grade.

obstructive sleep apnea medical

"Solriamfetol for Excessive Daytime Sleepiness in Narcolepsy and OSA..."

Obstructive sleep apnea is a common medical condition where the throat repeatedly narrows or closes during sleep, causing short pauses in breathing, drops in blood oxygen and fragmented rest. It matters to investors because it creates ongoing demand for medical devices, diagnostics, treatments and sleep-monitoring services, and it can affect population health, workforce productivity and healthcare spending—like a recurring leak in a system that requires continual repair and monitoring.

cataplexy medical

"AXS-12 in Narcolepsy with Cataplexy... residual cataplexy: Subgroup Analysis"

Cataplexy is sudden, brief loss of muscle control triggered by strong emotions such as laughter, surprise or anger; it can range from drooping facial muscles to full body collapse while the person remains conscious. For investors, cataplexy matters because its severity and chronic nature drive demand for treatments, influence clinical trial design and regulatory review, and affect market size, pricing and healthcare costs in neurology and sleep disorder portfolios.

narcolepsy medical

"AXS-12 in Narcolepsy with Cataplexy... Symptom Burden and Quality of Life in Patients with Narcolepsy"

A chronic neurological condition that causes sudden, uncontrollable episodes of deep sleep and extreme daytime drowsiness, like a phone that unexpectedly shuts off during the day. It matters to investors because it defines the market need for treatments, influences clinical trial results and regulatory decisions, and can drive revenue or risk for companies developing medications, devices, or diagnostics tied to sleep disorders.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

NEW YORK, June 15, 2026 (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 presentations of new data on AXS-12 and solriamfetol at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 14-17, 2026, in Baltimore, Maryland.

Details of the presentations are as follows:

• Title: Cognitive and Functional Outcomes from the Phase 3 Open-Label Extension and Randomized-Withdrawal ENCORE Trial of AXS-12 in Narcolepsy with Cataplexy
  Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
  Lead Author: Bruce Corser MD, FAASM, Medical Director of Intrepid Research, Cincinnati, OH
  Poster Presentation Session: P-16
  Poster Number: 375

• Title: Solriamfetol for Excessive Daytime Sleepiness in Narcolepsy and OSA: Post-hoc Multi-dimensional Composite Endpoint Analysis of Phase 3 Trials
  Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
  Lead Author: Ellen Wertmer, FNP-BC, DBSM, FAASM, Founder of Restorative Sleep Medicine, Charlottesville, VA
  Poster Presentation Session: P-16
  Poster Number: 386

• Title: Symptom Burden and Quality of Life in Patients with Narcolepsy Who Experience Residual Cataplexy: Subgroup Analysis from the CRESCENDO Survey
  Presentation Date and Time: Tuesday, June 16, 10:00 - 11:45 a.m. ET
  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
  Poster Presentation Session: P-34
  Poster Number: 316
  
  

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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
adong@axsome.com

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com

FAQ

What is Axsome Therapeutics (NASDAQ: AXSM) presenting at SLEEP 2026?

Axsome Therapeutics is presenting new data on AXS-12 and solriamfetol at SLEEP 2026. According to Axsome, the posters address narcolepsy with cataplexy, excessive daytime sleepiness in narcolepsy and OSA, and quality-of-life impacts in narcolepsy.

When are Axsome Therapeutics’ AXS-12 ENCORE trial results presented at SLEEP 2026?

The AXS-12 ENCORE trial data are presented Monday, June 15, 2026, from 10:00 to 11:45 a.m. ET. According to Axsome, this poster reports cognitive and functional outcomes in narcolepsy with cataplexy from a Phase 3 open-label extension and randomized-withdrawal study.

What does the solriamfetol Phase 3 analysis from Axsome (AXSM) focus on at SLEEP 2026?

The solriamfetol poster examines excessive daytime sleepiness in narcolepsy and OSA using a post-hoc multi-dimensional composite endpoint analysis of Phase 3 trials. According to Axsome, this analysis is presented Monday, June 15, 2026, during session P-16, poster number 386.

Which Axsome (AXSM) poster at SLEEP 2026 evaluates quality of life in narcolepsy?

A poster titled “Symptom Burden and Quality of Life in Patients with Narcolepsy Who Experience Residual Cataplexy” evaluates quality-of-life impacts. According to Axsome, this CRESCENDO survey subgroup analysis is presented Tuesday, June 16, 2026, session P-34, poster number 316.

Who are the lead authors on Axsome Therapeutics’ SLEEP 2026 posters?

The lead authors are Bruce Corser for the AXS-12 ENCORE trial, Ellen Wertmer for the solriamfetol analysis, and Michael Thorpy for the CRESCENDO survey. According to Axsome, each author presents within designated poster sessions P-16 and P-34.

Where is the SLEEP 2026 conference featuring Axsome (AXSM) sleep medicine data held?

SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies, is held in Baltimore, Maryland, June 14–17, 2026. According to Axsome, its AXS-12, solriamfetol, and CRESCENDO survey posters are scheduled within this meeting.