Binge-Eating Disorder

SAYLORSBURG, Pa., April 4, 2024 /PRNewswire/ -- Blue Ridge Eating Disorder Care Center announces it has earned The Joint Commission's Gold Seal of Approval for Behavioral Health Care Accreditation by maintaining compliance with performance standards. The Gold Seal of Approval is a symbol of quality that reflects Blue Ridge's commitment to providing safe and effective care for the young women they treat. In March of 2023, Blue Ridge Eating Disorder Care Center took part in a rigorous onsite survey that assessed their documentation, building safety, and programming. An organization can only achieve Gold Seal Approval after the accreditation process and a rigorous on-site evaluation. This approval honors a commitment to maintaining and exceeding quality benchmarks and patient safety standards. "The young women we serve deserve exceptional care, and we are proud to hold ourselves to high standards of treatment", says Erica Butler, Founder and Clinical Director. "Blue Ridge Eating Disorder Care Center is thrilled to receive accreditation from The Joint Commission, and it is such a rewarding experience to be rewarded by your peers for our dedication to bettering the lives of the vulnerable young women that we serve." Blue Ridge Eating Disorder Care Center's interdisciplinary team works together to develop and implement individualized and evidence-based treatment strategies for the young women seeking recovery at their facility. As the leader in standards development promoting quality and safety in health care organizations, The Joint Commission is currently the nation's largest and only accreditor that reaches across the full continuum of care. About Blue Ridge Eating Disorder Care Center Blue Ridge Eating Disorder Care Center for adolescent girls is situated in pastoral Saylorsburg in Monroe County, Pennsylvania. Just 30 miles north of Allentown, our adolescent eating disorder program is less than 90-minutes from Philadelphia and only a two-hour drive from NYC and New Jersey communities. Blue Ridge Eating Disorder Care Center is committed to the recovery of young women with disordered eating. Located in the serene Pennsylvania countryside, our team of professionals offer individualized treatment for girls diagnosed with ARFID, Anorexia, bulimia, OSFED, binge eating, and more. Blue Ridge's adolescent residential program is individualized for each patient struggling with disordered eating. As a small treatment center in the foothills of the Pocono Mountains, the team prides themselves on creating personalized treatment plans and goals for young women. In this intimate environment, the team can maintain a low patient-staff ratio that helps avoid the cookie-cutter approach of large eating disorder centers. The residential program is a collaborative design of parental concerns, patient input, and clinical guidance that address a child's needs, and goals, while leveraging their strengths. For more information on Blue Ridge Eating Disorder Care Center or to schedule a free assessment, please call 570-718-8800 or email [email protected] The Joint Commission Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission accredits and certifies more than 21,000 health care organizations and programs in the United States. An independent, nonprofit organization, The Joint Commission is the nation's oldest and largest standards setting and accrediting body in health care. Learn more about The Joint Commission at . SOURCE Blue Ridge Eating Disorder Care Center

BOSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Cerevance, a company focused on developing precision novel therapeutics for central nervous system (CNS) diseases, today announced participation at the upcoming 23rd Annual Needham Virtual Health Care Conference. The event takes place from April 8-11, 2024. Company management will also host one-on-one meetings during the conference. About CerevanceCerevance is focused on the development of precision treatments for central nervous system (CNS) disorders, including chronic neurodegenerative conditions such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS). Utilizing a large and growing repository of over 14,000 human brain tissue samples, Cerevance is generating an unprecedented level of expression and epigenetic data thereby enabling the company to identify the most promising targets for the next generation of treatments for CNS disorders. The company uses its proprietary NETSseq platform and advanced machine learning techniques to uncover the gene expression profiles of select cell types to identify novel targets that are uniquely expressed in relevant circuits affected by diseases or are altered in disease states. With the information obtained from its research, combined with the expertise of its team of scientists and drug developers, Cerevance is advancing multiple therapeutics that selectively modulate the discovered targets. These treatments are progressing through clinical development, with CVN424, CVN766, and CVN293 being the furthest along in the pipeline. CVN424 is a first-in-class non-dopamine therapy that shows promise in improving both motor and non-motor symptoms of Parkinson's disease and may also have disease- delaying effects. CVN766 is a potent antagonist of the orexin 1 receptor with high selectivity (>1,000 fold) over the orexin 2 receptor which may benefit a variety of psychiatric conditions including schizophrenia, anxiety/panic, binge eating/obesity, substance use disorder, and Prader-Willi Syndrome. CVN293 is a novel blocker of potassium efflux in glia, regulating the inflammasome in individuals living with ALS and Alzheimer's disease. Cerevance’s robust pipeline aims to transform the lives of individuals affected by CNS diseases. Contacts Cerevance:Johnna Simoes, ir@cerevance.com Media:Andrew Mielach, amielach@lifescicomms.com, +1-646-876-5868

NEW YORK, April 01, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced the initiation of the ENGAGE Phase 3 trial of solriamfetol, an investigational treatment for binge eating disorder (BED) in adults. ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of BED in adults. Approximately 450 patients will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo for 12 weeks. The primary endpoint will be the change in binge eating episodes. The first patient was screened in the ENGAGE trial in March 2024. About Binge Eating Disorder Binge eating disorder (BED) is a serious, chronic biologically based disorder characterized by recurrent episodes of eating excessive amounts of food within a discrete period of time while also feeling a lack of control over the eating, distress about the bingeing, and without weight-compensatory behaviors seen in bulimia nervosa, such as purging.1 BED is the most common eating disorder, affecting an estimated 2.8% of U.S. adults, or about 7 million, and it is 1.75 times more common in women.2 About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. Solriamfetol is not approved by the FDA for the treatment of binge eating disorder. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. We 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 continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; 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 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 continued commercialization of Sunosi and Auvelity 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; unforeseen circumstances or other disruptions to normal business operations arising from or related to 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 circumstance. Axsome Contacts: Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com Media:Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com References: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Arlington, VA: American Psychiatric Association; 2013.J. I. Hudson, E. Hiripi, H. G. Pope, and R. C. Kessler, “The Prevalence and Correlates of Eating Disorders in the National Comorbidity Survey Replication,” Biol. Psychiatry, vol. 61, no. 3, pp. 348–358, Feb. 2007, doi: 10.1016/j.biopsych.2006.03.040.