reboxetine (AXS-12) / Pfizer, Axsome Therap - LARVOL DELTA

Axsome Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. (Yahoo Finance) - "The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027."

FDA filing • PDUFA • Cataplexy • Narcolepsy

Axsome Therapeutics…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... (GlobeNewswire)

Clinical data • Narcolepsy • Sleep Disorder

Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results From the Phase Three SYMPHONY Trial (AAN 2026) - "Conclusions AXS-12 demonstrated a reduction in clinical impression of overall narcolepsy symptom severity, functional impairment due to EDS, and improved mood-related symptoms. Combined with prior findings, these results highlight the potential of AXS-12 to address narcolepsy symptoms affecting quality of life and functioning."

Cataplexy • CNS Disorders • Depression • Mood Disorders • Narcolepsy • Sleep Disorder

ENCORE: Topline Results of a Phase Three Open-label Extension and Randomized-withdrawal Trial of AXS-12 in Narcolepsy (AAN 2026) - "Switching to placebo resulted in significant worsening of cataplexy attack frequency relative to continued AXS-12 treatment. These results support the therapeutic impact of AXS-12 for narcolepsy."

Clinical • Cardiovascular • Cataplexy • Narcolepsy • Sleep Disorder

FORWARD: Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design (clinicaltrials.gov) - P3 | N=620 | Recruiting | Sponsor: Axsome Therapeutics, Inc.

New P3 trial • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission (GlobeNewswire) - "Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an NDA for AXS-12 for the treatment of cataplexy in narcolepsy. Axsome anticipates completing the NDA submission in January 2026. Acceptance of the final NDA will be subject to the FDA’s review of the complete filing."

FDA event • FDA filing • Narcolepsy

Axsome Therapeutics Highlights Data Across Its Leading Neuroscience Pipeline at Psych Congress 2025 (GlobeNewswire) - "Six poster presentations showcase clinical and real-world data in major depressive disorder, Alzheimer’s disease agitation, narcolepsy, and obstructive sleep apnea."

Clinical data • Alzheimer's Disease • Major Depressive Disorder • Narcolepsy • Obstructive Sleep Apnea

Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline (GlobeNewswire) - "Dr. Chadwick will provide an overview of fibromyalgia and of the previously completed Phase 2 and Phase 3 clinical trials of AXS-14 in the indication...Dr. Cummings will provide an overview of Alzheimer's disease (AD) agitation and discuss the results of the ADVANCE and ACCORD Phase 3 trials of AXS-05 in the indication...Cutler will provide an overview of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), and excessive sleepiness associated with shift work disorder (SWD), and discuss the results of the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively...Dr. Tepper will provide an overview of migraine and will discuss results from the MOMENTUM and INTERCEPT Phase 3 trials of SYMBRAVO in the acute treatment of migraine with and without aura....Dr. Thorpy will provide an overview of narcolepsy and will discuss the results of the clinical trial program of AXS-12 in the indication."

Clinical data • Trial status • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Excessive Daytime Sleepiness • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy • Psychiatry • Sleep Disorder

Anticipated Milestones (GlobeNewswire) - "Regulatory and Commercial: AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025); AXS-12 for narcolepsy, NDA submission (4Q 2025)...Clinical Trial Initiations and Progress....Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (4Q 2025); Phase 3 trial of solriamfetol in MDD with EDS, initiation (4Q 2025)."

FDA filing • New P2/3 trial • New P3 trial • Alzheimer's Disease • Excessive Daytime Sleepiness • Major Depressive Disorder • Narcolepsy

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Regulatory and Commercial: SYMBRAVO for the acute treatment of migraine, commercial launch (June 2025); AXS-14 for fibromyalgia, FDA filing acceptance decision (2Q 2025); AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025); AXS-12 for narcolepsy, NDA submission (2H 2025)."

FDA filing • Launch • Alzheimer's Disease • Fibromyalgia • Migraine • Narcolepsy

AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial (AAN 2025) - "Stable concurrent modafinil/armodafinil use was allowed. AXS-12 met its primary endpoint, leading to a substantial, statistically significant reduction in weekly cataplexy attacks. Improvements in EDS and cognition were also observed, suggesting AXS-12 may offer effective treatment for multiple narcolepsy symptoms with a favorable safety profile."

P3 data • P3 data: top line • Alzheimer's Disease • Cataplexy • Cognitive Disorders • Constipation • Excessive Daytime Sleepiness • Gastroenterology • Gastrointestinal Disorder • Narcolepsy • Sleep Disorder • Xerostomia

Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated Milestones - Regulatory and Commercial: AXS-14 for fibromyalgia, NDA submission (1Q 2025)....AXS-12 for narcolepsy, NDA submission (2H 2025). Clinical Trial Topline Results: Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025); Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025); Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025); Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026); Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)."

P3 data: top line • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE) (clinicaltrials.gov) - P3 | N=68 | Completed | Sponsor: Axsome Therapeutics, Inc. | Enrolling by invitation ➔ Completed

Trial completion • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SYMPHONY: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy (clinicaltrials.gov) - P3 | N=90 | Completed | Sponsor: Axsome Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Trial completion • Trial completion date • Trial primary completion date • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (clinicaltrials.gov) - P3 | N=90 | Enrolling by invitation | Sponsor: Axsome Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (clinicaltrials.gov) - P3; N=90; Enrolling by invitation; Sponsor: Axsome Therapeutics, Inc.

Clinical • New P3 trial • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SYMPHONY: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy (clinicaltrials.gov) - P3; N=90; Recruiting; Sponsor: Axsome Therapeutics, Inc.

Clinical • New P3 trial • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Axsome Therapeutics Initiates SYMPHONY Phase 3 Trial of AXS-12 in Narcolepsy (GlobeNewswire) - "Axsome Therapeutics, Inc...enrolled the first patient in SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy), a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-12 in patients with narcolepsy....Topline results from the SYMPHONY trial are anticipated in the first half of 2023."

P3 data: top line • Trial status • CNS Disorders • Narcolepsy • Sleep Disorder

Axsome breakthrough therapy designation for narcolepsy therapy removed by FDA (SeekingAlpha) - "Axsome Therapeutics...announced that the FDA has canceled the Breakthrough Therapy Designation granted for AXS-12, a product candidate targeting cataplexy in narcolepsy. The decision followed the approval of an additional drug for the indication after AXS-12 was granted the Breakthrough Therapy Designation. 'The Company does not currently anticipate any changes to the development plans or associated timelines for AXS-12 as a result of this change,'..."

Breakthrough therapy designation • Cataplexy • CNS Disorders • Narcolepsy • Sleep Disorder

Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-07; Axsome plans to announce the FDA’s decision regarding its acceptance of the NDA filing in the third quarter of 2021. AXS-12; Narcolepsy: Axsome is planning to initiate a Phase 3 trial of AXS-12 in the treatment of narcolepsy early in the third quarter of 2021. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study."

FDA event • New P3 trial • CNS Disorders • Migraine • Narcolepsy • Pain • Sleep Disorder

Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-07: AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine...Axsome is compiling the NDA for AXS-07 for the acute treatment of migraine. Submission of this NDA is expected in early second quarter....Axsome is planning to initiate a Phase 3 trial of AXS-12 in the treatment of narcolepsy in the second quarter. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study....Clinical Trial Initiations: Phase 3 trial of AXS-12 in the treatment of narcolepsy (2Q 2021)...FDA Meetings: AXS-14 for fibromyalgia (2Q 2021)."

FDA event • NDA • New P3 trial • CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Narcolepsy • Pain • Sleep Disorder

Advances in treatment of narcolepsy (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - "Pitolisant (a histamine H3 receptor antagonist) and solriamfetol (a norepinephrine reuptake inhibitor) have recently been approved effective for narcolepsy in the United States and the European Union. These new drugs include new hydroxybutyrate preparations (controlled release sodium hydroxybutyrate FT218, low sodium hydroxybutyrate JZP-258), selective norepinephrine reuptake inhibitor (AXS-12), and modafinil combined with astroglial junction protein inhibitor (THN102). This paper reviews the recently approved drugs and potential treatments for narcolepsy."

Journal • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Obstructive Sleep Apnea • Psychiatry • Sleep Disorder

Axsome Therapeutics: An Excellent Pipeline Of Approvable CNS Products (SeekingAlpha) - P2, N=21; CONCERT (NCT03881852); Sponsor: Axsome Therapeutics, Inc.; "The name of the trial was CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy...AXS-12 met the prespecified primary endpoint...AXS-12 was safe and well-tolerated. There were no serious adverse events reported in the trial, and no discontinuations due to adverse events."

P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Sleep Disorder

Axsome Therapeutics Announces $225 Million Term Loan Facility with Hercules Capital (GlobeNewswire) - "Axsome Therapeutics, Inc....has secured a $225 million term loan facility with Hercules Capital, Inc....The committed capital strengthens the Company’s balance sheet through the anticipated commercial launches of its two lead product candidates, AXS-05 for major depressive disorder (MDD) and AXS-07 for migraine....'We will continue to advance the rest of our differentiated late-stage CNS pipeline...AXS-05 in Alzheimer’s disease agitation and AXS-12 in narcolepsy'....$60 million may be drawn at closing; $115 million may be drawn at the Company’s option, in three separate tranches, upon approval of AXS-05 in MDD, upon approval of AXS-07 in migraine, and upon certain combined sales criteria for AXS-05 and AXS-07."

Financing • Alzheimer's Disease • CNS Disorders • Depression • Migraine • Narcolepsy • Pain

Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc....today announced that the development plan for AXS-12 for the treatment of narcolepsy has been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA)....The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of an NDA (New Drug Application) for approval of AXS-12 for the treatment of cataplexy in narcolepsy....Axsome intends to initiate this trial in 1Q 2021. Patients completing this trial will be eligible to enroll in an open-label safety extension study."

New P3 trial • New trial • CNS Disorders • Narcolepsy • Sleep Disorder