{"id":915591,"date":"2025-12-03T07:04:54","date_gmt":"2025-12-03T12:04:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease\/"},"modified":"2025-12-03T07:04:54","modified_gmt":"2025-12-03T12:04:54","slug":"bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease\/","title":{"rendered":"Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease<\/b><\/p>\n<p class=\"bwalignc\"><b>Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee<\/b><\/p>\n<p class=\"bwalignc\"><b>BMS Remains Blinded to Study Data<\/b><\/p>\n<p>PRINCETON, N.J.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.bms.com%2F&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=0e97db6ca337c85681e318ff1137ad07\">Bristol Myers Squibb<\/a> (NYSE: BMY, \u201cBMS\u201d) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. Following consultation and agreement with the U.S. Food and Drug Administration (FDA), an interim data analysis for efficacy and safety was conducted by an independent party and reviewed by the Data Monitoring Committee (DMC).\n<\/p>\n<p>\nFollowing this analysis, the DMC recommended the study continue by enrolling additional patients to the original target study population. Based on this recommendation, BMS will continue patient enrollment and advance the program as advised by the DMC. BMS remains blinded to study data.\n<\/p>\n<p>\n\u201cBMS agrees with the decision made in consultation with the FDA and DMC to continue the Phase 3 study and will move forward with recruiting additional patients,\u201d said Laura Gault, MD, PhD, Senior Vice President, Head of Development, Neuroscience Drug Development, Bristol Myers Squibb. \u201cOur decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies. Psychosis related to Alzheimer\u2019s Disease remains an area of tremendous unmet medical need, and maintaining rigorous standards is essential as we work to identify innovative treatment options for patients and families affected by this devastating condition.\u201d\n<\/p>\n<p><i>Cobenfy<\/i>, currently approved for the treatment of schizophrenia in adults, has the potential to be the first treatment in a new class of pharmacologic therapies targeting agitation and psychosis based on muscarinic receptor agonism. Additional trial results from the ADEPT program in psychosis associated with Alzheimer&#8217;s Disease, including ADEPT-2, ADEPT-1 and ADEPT-4, are expected to read out by the end of 2026.\n<\/p>\n<p>\nBMS is taking a holistic approach to developing novel approaches to treat Alzheimer\u2019s Disease, dually pursuing investigational therapies that aim to both meaningfully slow disease progression and to ease symptoms to help give patients, families and caregivers back some of what the disease has taken away.\n<\/p>\n<p><b>About ADEPT-2<br \/>\n<br \/><\/b>The ADEPT-2 study (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fclinicaltrials.gov&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=clinicaltrials.gov&amp;index=2&amp;md5=9ce954b1b00dcab8bd4283781687d66c\">clinicaltrials.gov<\/a>, NCT06126224) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of <i>Cobenfy<\/i> in subjects with psychosis associated with Alzheimer\u2019s disease dementia. The study is designed to evaluate the primary endpoint of changes in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score and the key secondary endpoint of Clinical Global Impression-Severity (CGI-S), with additional assessments on safety and tolerability of <i>Cobenfy<\/i> compared to placebo.\n<\/p>\n<p><b>About Bristol Myers Squibb<br \/>\n<br \/><\/b>Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fbit.ly%2F3WPHG0O&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=BMS.com&amp;index=3&amp;md5=0076bbd718c30fd30c70a05328560891\">BMS.com<\/a> or follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fbristol-myers-squibb%2F&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=d07c103ab2a65d8732f4ad739e7b7b22\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fbmsnews&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=X&amp;index=5&amp;md5=596cef887c96858049414937014e7471\">X<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUCjFf4oKibYrHae2NZ_GPS6g&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=YouTube&amp;index=6&amp;md5=d06362ebe871e120c4ecd46768c853de\">YouTube<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FBristolMyersSquibb%2F&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=Facebook&amp;index=7&amp;md5=ee79360bf9621bf469b529eb868a3dc7\">Facebook<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Faccounts%2Flogin%2F%3Fnext%3Dhttps%253A%252F%252Fwww.instagram.com%252Fbristolmyerssquibb%252F%26is_from_rle&amp;esheet=54367779&amp;newsitemid=20251203856535&amp;lan=en-US&amp;anchor=Instagram&amp;index=8&amp;md5=110d4dfc56ad69dc01ea30fcb3cbed0c\">Instagram<\/a>.\n<\/p>\n<p><b>Cautionary Statement Regarding Forward-Looking Statements<br \/>\n<br \/><\/b>This press release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility of unfavorable results from further clinical trials involving <i>Cobenfy<\/i> and whether <i>Cobenfy<\/i> for the additional indications described in this release will be successfully developed and commercialized. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb\u2019s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb\u2019s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.\n<\/p>\n<p>\ncorporatefinancial-news\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251203856535r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20251203856535\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20251203856535\/en\/<\/a><\/span><\/p>\n<p><b>Media Inquiries:<br \/>\n<\/b><br \/><a rel=\"nofollow\" href=\"mailto:media@bms.com\"><b>media@bms.com<\/b><\/a><\/p>\n<p><b>Investors:<br \/>\n<\/b><br \/><a rel=\"nofollow\" href=\"mailto:investor.relations@bms.com\"><b>investor.relations@bms.com<\/b><\/a><\/p>\n<p><b>KEYWORDS:<\/b> New Jersey United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health Neurology Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251203856535\/en\/2041631\/3\/bms_logo_300_rgb_pos.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;Bristol Myers Squibb (NYSE: BMY, \u201cBMS\u201d) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. Following consultation &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-915591","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#039;s Disease - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#039;s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;Bristol Myers Squibb (NYSE: BMY, \u201cBMS\u201d) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/bristol-myers-squibb-announces-continuation-of-adept-2-phase-3-study-in-psychosis-associated-with-alzheimers-disease\/","og_locale":"en_US","og_type":"article","og_title":"Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer's Disease - Market Newsdesk","og_description":"Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer&#8217;s Disease Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;Bristol Myers Squibb (NYSE: BMY, \u201cBMS\u201d) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. 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