SUNOSI


Associated tags: Pharmaceutical industry, Therapy, Narcolepsy, Patient, EDS, CNS, Solriamfetol, Central nervous system, Obstructive sleep apnea, MD, OSA, Somnolence, SHARP, Migraine, Wakefulness, Safety

Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones

Retrieved on: 
Thursday, January 4, 2024
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“Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients.

Key Points: 
  • “Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients.
  • Auvelity® net product sales are expected to be approximately $49 million and $130 million for the fourth quarter and full year of 2023, respectively.
  • Sunosi® net product revenue is expected to be $22 million and $74 million for the fourth quarter and full year of 2023, respectively.
  • Net product revenue excludes $66 million in license revenue recognized by Axsome in the first quarter of 2023.

Axsome Therapeutics to Present New Sunosi® Data at SLEEP 2023

Retrieved on: 
Thursday, June 1, 2023
Cognition, Central nervous system, University, Solriamfetol, Harm, Somnolence, EDS, Sleep Research Society, American Academy, Department of Neurology, Xuanwu hospital, Date, Doctor of Philosophy, CNS, Epilepsy, American Academy of Sleep Medicine, Number needed to treat, Patient, Randomness, Therapy, SHARP, Obstructive sleep apnea, Washington State University, Pharmaceutical industry, Flour, Narcolepsy, Apnea, MD

NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Sunosi® (solriamfetol) at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held in Indianapolis, Ind., from June 3-7, 2023.

Key Points: 
  • NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Sunosi® (solriamfetol) at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held in Indianapolis, Ind., from June 3-7, 2023.
  • The presentations include new data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA), demonstrating sustained improvement with Sunosi on measures of cognition across 8-hours with once daily dosing.
  • Additional new data and analyses include real-world data from OSA patients taking Sunosi as part of the SURWEY study in Germany, healthcare resource use in OSA patients with residual EDS, and effect sizes and numbers needed to treat analyses.
  • “Cognitive impairment is a substantial burden to many patients with EDS and OSA.

Axsome Therapeutics to Present Data and Post-Hoc Analyses on Auvelity® and Sunosi® at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023
Presenteeism, Major depressive disorder, Central nervous system, Solriamfetol, Obstructive sleep apnea, Somnolence, State University of New York Upstate Medical University, EDS, Narcolepsy, Disability, Functional disorder, OSA, CNS, ASCP, Drug, MDD, MD, Patient, Domain, Ontario Prehospital Advanced Life Support Studies, Randomness, Medication discontinuation, Annual general meeting, Magnetic resonance, United, Therapy, SHARP, Society, Dextromethorphan/bupropion, Cognitive deficit, Pharmaceutical industry, Medical device, Apnea

NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Auvelity® (dextromethorphan-bupropion), Sunosi® (solriamfetol), and disease state at the upcoming American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30-June 3 in Miami. The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD). The presentations on Sunosi include data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).

Key Points: 
  • NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Auvelity® (dextromethorphan-bupropion), Sunosi® (solriamfetol), and disease state at the upcoming American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30-June 3 in Miami.
  • The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD).
  • The presentations on Sunosi include data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).
  • “MDD is the leading cause of disability worldwide and improvement in functioning is critically important to people with MDD.

Axsome Therapeutics to Present Five Abstracts Including New Data from the Positive SHARP Study of SUNOSI® (solriamfetol) in Participants with Cognitive Impairment with Excessive Daytime Sleepiness in Obstructive Sleep Apnea at the 2023 American Academy of

Retrieved on: 
Friday, April 21, 2023
Abstract, Migraine, Narcolepsy, Central nervous system, University, Obstructive sleep apnea, Somnolence, EDS, AAN, Deficit spending, TAAR1, American Academy, OSA, CNS, Patient, Annual general meeting, Magnetic resonance, Cognitive deficit, Therapy, SHARP, Washington State University, American Academy of Neurology, Pharmaceutical industry, Solriamfetol, Safety

NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston.

Key Points: 
  • NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston.
  • These presentations include new data from the SHARP study, a randomized, double-blind, placebo-controlled, crossover, multicenter trial in 59 patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) and impaired cognitive function, from which positive topline results were announced in October 20221.
  • “The SHARP study is exciting because it overcomes treatment barriers associated with the complex relationship between cognitive impairment and OSA,” said Hans Van Dongen, Ph.D., Professor at Washington State University and first author of the SHARP study abstract.
  • “Endpoints from the SHARP study show potential clinical benefit for patients taking solriamfetol versus placebo, suggesting it can be a robust option for the treatment of patients with EDS due to OSA.

Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi® (solriamfetol) in Europe

Retrieved on: 
Wednesday, February 22, 2023
Marketing, Safety, Therapy, OSA, Central nervous system, MD, EDS, LLP, Morgan Stanley, Narcolepsy, European Medicines Agency, Patient, CNS, Dopamine, Wakefulness, EMA, Obstructive sleep apnea, DLA Piper, Pharmaceutical industry, Solriamfetol

NEW YORK, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has entered into an exclusive license agreement with Pharmanovia to commercialize and further develop Sunosi® (solriamfetol), the first and only dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA), in Europe and certain countries in the Middle East and North Africa (MENA).

Key Points: 
  • Under the terms of the agreement, Pharmanovia will be responsible for marketing Sunosi in Europe and MENA regions and will assume responsibility for all local clinical and regulatory activities and requirements including studies in pediatric patients.
  • Axsome will receive an upfront payment of $66 million and is eligible to receive sales-based and other milestones totaling up to $101 million.
  • Axsome will receive a royalty percentage in the mid-twenties on net sales.
  • We are delighted to partner with Axsome, a leading CNS-focused biopharmaceutical company, and to expand the overseas launch and further the clinical development of Sunosi.

Pharmanovia Enters In-Licensing Agreement With Axsome Therapeutics to Market and Further Develop Sunosi® (solriamfetol), a First-In-Class Treatment for Excessive Daytime Sleepiness (EDS) in People With Narcolepsy and Obstructive Sleep Apnoea

Retrieved on: 
Wednesday, February 22, 2023
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, Safety, Therapy, OSA, EDS, Narcolepsy, Partnership, Brain, Patient, Sleep, Wakefulness, Attention deficit hyperactivity disorder, Fatigue, Sleep apnea, ADHD, Pharmaceutical industry

The agreement gives Pharmanovia the exclusive marketing rights to Sunosi® (solriamfetol), a first in class medicine used to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnoea (OSA)1, in Europe and MENA regions.

Key Points: 
  • The agreement gives Pharmanovia the exclusive marketing rights to Sunosi® (solriamfetol), a first in class medicine used to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnoea (OSA)1, in Europe and MENA regions.
  • Pharmanovia will continue researching solriamfetol’s potential in children.
  • The agreement also allows Pharmanovia to explore solriamfetol’s potential in other neurological conditions, such as attention deficit hyperactivity disorder (ADHD).
  • Partnering with Pharmanovia is a natural choice for us, given their alignment with us on the value that solriamfetol presents and their plans to expand access.”

Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today

Retrieved on: 
Thursday, October 27, 2022
Boxed warning, Nasdaq MarketSite, Narcolepsy, Company, CNS, OSA, Dopamine, MD, NASDAQ, Depression, Wakefulness, Breakthrough therapy, Food, Physician, EDS, Excessive daytime sleepiness, Food and Drug Administration, NMDA, Schedule, Dextromethorphan, Hydrogen chloride, MDD, Patient, Bupropion, Adult, Research, GLOBE, Nasdaq, Obstructive sleep apnea, Therapy, FDA, HBR, Times Square, CYP2D6, Medication, Migraine, Central nervous system, Pharmaceutical industry, Solriamfetol, COVID-19

NEW YORK, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsomes Chief Executive Officer, the rest of the management team, along with other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Thursday, October 27, 2022, to commemorate the availability of AUVELITY in the United States by prescription.

Key Points: 
  • NEW YORK, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsomes Chief Executive Officer, the rest of the management team, along with other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Thursday, October 27, 2022, to commemorate the availability of AUVELITY in the United States by prescription.
  • We are honored to ring NASDAQs opening bell to commemorate the availability of Auvelity by prescription and the hard work and dedication of the Axsome team which made it possible.
  • The ceremony will take place at the Nasdaq MarketSite, 4 Times Square, New York, NY.
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options.