Axsome Therapeutics Initiates SUMMIT Phase 3 Trial of AXS-05 in Smoking Cessation

Rhea-AI Summary

Axsome Therapeutics (NASDAQ: AXSM) reported dosing the first patient in SUMMIT, a Phase 3 trial of AXS-05 for smoking cessation. The randomized, double-blind, active- and placebo-controlled multicenter study will compare AXS-05, bupropion, and placebo over approximately 12 weeks in adult smokers, with the primary endpoint of smoking abstinence at week 12.

Market Context

The prior FOCUS-3 initiation was followed by a 1.83% 24-hour move, framing SUMMIT within mixed trial...

Analysis

The prior FOCUS-3 initiation was followed by a 1.83% 24-hour move, framing SUMMIT within mixed trial-start history; recent insider context showed Net Selling, a risk factor to monitor alongside endpoint execution.

Key Figures

Trial phase: Phase 3 Randomization ratio: 1:1:1 Treatment period: 12 weeks

3 metrics

Trial phase Phase 3 SUMMIT trial of AXS-05

Randomization ratio 1:1:1 AXS-05, bupropion, or placebo

Treatment period 12 weeks Smoking cessation trial

Previous Clinical trial Reports

5 past events · Latest: Jul 15 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 15	FDA filing acceptance	Positive	+1.0%	FDA accepted the AXS-12 NDA and assigned a May 1, 2027 PDUFA date.
Jul 07	Phase 3 trial initiation	Positive	+3.0%	First patient dosed in FOCUS-2 trial for pediatric ADHD.
Jun 26	Phase 3 trial initiation	Positive	+1.8%	First patient dosed in FOCUS-3 trial for adolescent ADHD.
Feb 24	Phase 3 trial initiation	Positive	-2.8%	First patient dosed in CLARITY trial for depression with daytime sleepiness.
Jan 15	Phase 3 trial initiation	Positive	-1.6%	First patient dosed in FORWARD trial for fibromyalgia.

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

Pattern Detected

Three of five tag-specific clinical-trial announcements were followed by positive reactions, while two diverged.

Key Terms

nmda, sigma-1, double-blind, placebo-controlled

4 terms

nmda medical

"SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment)"

An NMDA receptor is a protein on nerve cells that acts like a gate controlling certain electrical signals and calcium flow in the brain; drugs that block or activate this gate can change how neurons communicate. Investors care because medicines that target NMDA receptors can treat conditions such as pain, depression, and neurological disorders, so progress or setbacks in trials, safety findings, or approvals can strongly affect a biotech company's value.

sigma-1 medical

"SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment)"

A sigma-1 is a type of protein receptor found in cells, especially in the brain and nervous system, that helps regulate how cells respond to stress and control signals between different cell parts. It matters to investors because drugs that activate or block this receptor are being studied as potential treatments for neurological, psychiatric, and other diseases; success or failure in trials can strongly affect companies developing those medicines.

double-blind medical

"a Phase 3 randomized, double-blind, active- and placebo-controlled"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"double-blind, active- and placebo-controlled, multicenter trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

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, Aug. 31, 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 that the first patient has been dosed in the SUMMIT Phase 3 trial of AXS-05 for smoking cessation.

SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment) is a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 as a smoking cessation treatment in adults. Active smokers will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for approximately 12 weeks. The primary endpoint will be smoking abstinence at the end of the 12-week treatment period.    

About Smoking Cessation

Approximately 34 million adults in the U.S. smoke cigarettes and more than half of those live with a smoking-related disease.¹ Smoking is the single largest cause of preventable disease in the U.S., accounting for 1 in 5 deaths.² The overall cost of smoking exceeds $300 billion annually in the U.S. making it a significant health-economic need.¹ Nearly 70% of adult smokers say they want to quit but only 3-5% who attempt to quit without assistance are successful for 6-12 months.^1,3

About AXS-05

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for smoking cessation. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 (AUVELITY^®) is approved in the U.S. for the treatment of major depressive disorder in adults and agitation associated with dementia due to Alzheimer’s disease. AXS-05 is not approved by the FDA as a smoking cessation treatment.

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, 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:
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

References:

1. U.S. Department of Health and Human Services. (2020). Smoking Cessation: A Report of the Surgeon General.
2. U.S. Centers for Disease Control and Prevention. (2020). Tobacco-Related Mortality
3. Hughes, J.R. et al. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2003. (99):29-38.
   

FAQ

What did Axsome Therapeutics (AXSM) announce about the AXS-05 SUMMIT Phase 3 trial?

Axsome Therapeutics announced that the first patient has been dosed in the SUMMIT Phase 3 trial of AXS-05 for smoking cessation. According to Axsome, this multicenter study will evaluate efficacy and safety versus bupropion and placebo over about 12 weeks.

What is the design of Axsome's SUMMIT Phase 3 AXS-05 smoking cessation trial (AXSM)?

The SUMMIT trial is a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter study in adult smokers. According to Axsome, participants are randomized 1:1:1 to AXS-05, bupropion, or placebo and treated for approximately 12 weeks.

What is the primary endpoint in Axsome Therapeutics' SUMMIT Phase 3 trial of AXS-05 (AXSM)?

The primary endpoint is smoking abstinence at the end of the 12-week treatment period. According to Axsome, the trial will assess whether AXS-05 improves quit rates compared with bupropion and placebo in adult smokers.

How long will participants be treated in Axsome's AXS-05 SUMMIT Phase 3 smoking cessation trial?

Participants will receive study treatment for approximately 12 weeks. According to Axsome, adult smokers are randomized to AXS-05, bupropion, or placebo in a 1:1:1 ratio, with smoking abstinence at 12 weeks as the primary outcome.

Which treatments are being compared in Axsome Therapeutics' SUMMIT Phase 3 smoking cessation study (AXSM)?

The SUMMIT trial compares AXS-05, bupropion, and placebo in adult smokers. According to Axsome, participants are randomized equally among the three arms to evaluate the efficacy and safety of AXS-05 for smoking cessation.