Lithium succinate

AUSTIN, Texas, Feb. 17, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Biotech dealmaking is increasingly defined by a clear strategic shift: Pharmaceutical companies are prioritizing de-risked, late-stage assets with human clinical validation rather than speculative early-stage programs. After years of capital flowing into preclinical platforms with uncertain timelines, investors and acquirers are gravitating toward programs with established safety and efficacy data that can accelerate commercialization pathways. This evolving landscape naturally places companies such as Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile), which holds multiple clinical-stage and late-stage programs across oncology and central nervous system (CNS) indications, into focus as strategic assets aligned with current M&A priorities. The company just announced key advancements in its global intellectual property portfolio supporting OT-101, its proprietary TGF-β antisense therapeutic platform. The advancements strengthen protection across neurology, oncology and central nervous system (CNS) drug delivery designed to deliver drugs into the brain by getting through the blood brain barrier. This M&A trend bolsters Oncotelic Therapeutics’ position in the oncology and CNS sectors as OTLC joins other companies focused on the space, including Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR), MeiraGTx Holdings plc (NASDAQ: MGTX), Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) and Johnson & Johnson (NYSE: JNJ). Central nervous system disorders such as brain cancer, Alzheimer’s Disease, Parkinson’s Disease and others represent one of the largest and most challenging therapeutic categories in modern medicine. The convergence of CNS and oncology makes Oncotelic’s update on expanding international IP coverage for OT-101 even more impactful. Oncotelic Therapeutics’ focus on delivery approaches relevant to CNS and oncology aligns with the industry’s direction. Oncotelic Therapeutics’ development of OT-101 demonstrates its advanced R&D capabilities and innovative repositioning approach by exploring applications across oncology indications supported by mechanistic rationale and prior clinical research. Oncotelic Therapeutics positions itself with a diversified portfolio spanning oncology-focused therapies, CNS indications and delivery technologies. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. Big Pharma’s Shift Toward Proven Assets Biopharma dealmaking has increasingly centered on external innovation, licensing, and acquisitions of assets that demonstrate clinical validation. Strategic analyses from McKinsey & Company describe continued reliance on partnerships and acquisitions to replenish pipelines as internal R&D productivity challenges persist. Similarly, Deloitte’s life sciences M&A outlook highlights ongoing selectivity and capital discipline, encouraging companies to prioritize assets with clearer development paths and measurable progress toward commercialization. This strategic pivot reflects economic realities. Drug-development timelines remain long and costly, and investors have increasingly favored programs that demonstrate human safety or efficacy signals. Late-stage assets can reduce scientific uncertainty because clinical data provides clearer insight into safety profiles, dosing parameters, and potential regulatory pathways. As a result, companies nearing pivotal studies or late clinical phases may attract greater interest from acquirers seeking faster paths to market entry. Oncology and CNS programs have emerged as particularly strategic targets within this framework. Oncology continues to dominate pharmaceutical pipelines due to large commercial markets and ongoing innovation, while CNS disorders represent some of the most significant unmet medical needs globally. Assets that bridge these areas may offer differentiated positioning, especially when they address complex biological pathways or delivery challenges that have historically limited therapeutic success. Platforms supported by existing human data also carry valuation advantages. Programs that demonstrate clinical activity provide tangible milestones that investors can evaluate, reducing uncertainty compared with early discovery-stage platforms. This dynamic is contributing to growing attention toward companies holding clinical-stage portfolios rather than single preclinical assets. Oncotelic Therapeutics fits this strategic profile through its clinical-stage pipeline focused on oncology and CNS-related targets. A clinical-stage biopharmaceutical developer, the company is pursuing therapies for cancer and other serious conditions. Oncotelic’s programs, including those targeting TGF-β signaling and delivery-focused approaches, align with the broader industry emphasis on validated mechanisms and diversified development strategies. CNS, Oncology Markets Are Converging Central nervous system disorders represent one of the largest and most challenging therapeutic categories in modern medicine. The World Health Organization reports that neurological conditions are now among the leading causes of disability and illness worldwide, affecting more than one in three people globally. The growing burden of neurodegenerative disease has intensified the need for innovative treatments capable of addressing complex biological mechanisms. Alzheimer’s disease illustrates the scale of this unmet need. The Alzheimer’s Association estimates that millions of Americans currently live with the disease and that the economic burden continues to rise sharply, reflecting both healthcare costs and societal impact. Parkinson’s disease shows similar trends, with prevalence expected to increase as populations age, reinforcing the long-term importance of CNS therapeutic innovation. The intersection between oncology and CNS research is becoming increasingly relevant because many biological pathways operate across disease categories. Immune regulation, inflammation and signaling pathways involved in tumor progression can also influence neurological disease processes. These overlaps create opportunities for therapeutic platforms that can be developed across multiple indications, potentially expanding commercial reach while leveraging shared scientific insights. From an investment perspective, cross-indication platforms may offer strategic advantages by enabling companies to pursue multiple markets simultaneously. Pharmaceutical companies evaluating acquisitions often look for mechanisms that extend beyond a single indication, as this can increase potential return on investment and support lifecycle management strategies. Oncotelic Therapeutics’ development strategy reflects this convergence by focusing on pathways such as TGF-β modulation, which has been extensively studied in oncology and immune regulation contexts. Research documents the role of TGF-β signaling in cancer biology and tumor microenvironment regulation. By targeting mechanisms relevant across multiple disease categories, the company aligns with the broader trend toward integrated therapeutic platforms. New Milestones Expand Long-Term Potential This convergence makes Oncotelic’s update on expanding international IP coverage for OT-101, its proprietary TGF-β antisense therapeutic platform, even more impactful. The company, along with Sapu Bioscience, noted that the platform “[strengthens] protection across neurology, oncology, and central nervous system (CNS) drug delivery.” OT-101 has multiple prior clinical trials conducted in various oncology indications including glioblastoma and pancreatic cancers. The compound was also investigated for additional applications in Acute Respiratory Distress Syndrome (ARDS) and COVID-19-related inflammatory conditions. Building on its established clinical foundation in oncology, the Company is advancing OT-101 as a broader central nervous system (CNS)-capable therapeutic platform, supported by targeted delivery technologies and expanded intellectual property coverage. The update noted that in Australia, the company has received allowed patent claims explicitly covering OT-101 for the treatment of Parkinson's disease, while in China and Germany, utility model patents have been granted that provide device-level protection for continuous intracranial infusion technologies relevant to CNS therapeutics. “Collectively, these IP developments establish an integrated OT-101 CNS commercialization platform, combining therapeutic use claims in neurology with granted delivery-device protection,” stated the company, which believes this expanded IP estate enhances OT-101's strategic value and supports future development, partnering, and commercialization efforts across oncology and neurological indications. “OT-101 has a well-established clinical foundation, including prior clinical trials in multiple oncology indications, including glioblastoma, and these new IP milestones significantly expand its long-term potential,” said Oncotelic CEO Dr. Vuong Trieu. “By securing Parkinson's disease claims in Australia and strengthening CNS delivery protection in China and Germany, we are building a globally defensible platform that supports both therapeutic use and delivery, while positioning the company for strategic partnerships and long-term shareholder value creation.” Drug Delivery Emerges as Strategic Differentiator Drug delivery has become an increasingly important focus area within biotech innovation, particularly for CNS therapies. The blood–brain barrier presents a significant biological obstacle, preventing many drugs from reaching effective concentrations within brain tissue. Peer-reviewed research highlights that this barrier can limit therapeutic success even when a drug demonstrates strong activity in preclinical models. Because of these challenges, delivery technologies capable of improving targeting or bioavailability are gaining strategic importance. Researchers increasingly view delivery systems as enabling technologies that can unlock previously inaccessible therapeutic pathways. Rather than viewing delivery as secondary to molecular discovery, investors and developers are recognizing it as a critical component of therapeutic success. Regulatory agencies also acknowledge the importance of delivery innovation. The U.S. Food and Drug Administration maintains specific frameworks for evaluating combination products that integrate drug and device components, underscoring the role administration methods play in clinical outcomes From a strategic standpoint, companies developing delivery technologies alongside therapeutic mechanisms may offer differentiated value propositions. Improved delivery can enhance safety, reduce systemic toxicity, or increase efficacy by concentrating treatment within target tissues. Oncotelic Therapeutics’ focus on delivery approaches relevant to CNS and oncology aligns with this industry direction. By emphasizing methods that may enhance therapeutic targeting and overcome biological barriers, the company operates within a segment increasingly viewed as a critical bottleneck, and therefore a strategic value driver, in modern drug development. Platform Repositioning Drives Capital Efficiency Biotech strategy increasingly emphasizes capital efficiency, and one emerging approach involves repositioning clinically validated mechanisms into additional therapeutic indications. Rather than starting from entirely new discovery programs, companies are expanding existing platforms into adjacent markets where scientific rationale already exists. This strategy can reduce risk because safety data and mechanistic understanding from earlier studies may inform future development pathways. Repositioning also allows companies to maximize the value of prior investments by generating multiple clinical opportunities from a single biological target or technology platform. The TGF-β pathway provides a strong example of this approach. Extensive scientific literature describes its role in tumor growth, immune modulation and inflammation, creating opportunities for therapies targeting this pathway across multiple diseases. Advances in understanding tumor microenvironment biology have renewed interest in therapeutic strategies that modulate TGF-β signaling. Oncotelic Therapeutics’ development of OT-101, which targets TGF-β2 mRNA, illustrates a repositioning approach by exploring applications across oncology indications supported by mechanistic rationale and prior clinical research. Studies investigating OT-101 in combination with standard therapies reflect ongoing efforts to expand its potential clinical applications. Platform repositioning may also enhance strategic flexibility for potential partners or acquirers. Companies capable of adapting mechanisms to multiple disease contexts can respond to evolving market conditions or regulatory landscapes, increasing long-term development optionality. Diversified Pipelines Reduce Binary Investment Risk Historically, biotech investment has often centered on single-asset companies, where success or failure depended heavily on one clinical outcome. However, diversified pipelines are increasingly viewed as advantageous because they distribute risk across multiple programs and timelines. A multiasset strategy can provide resilience during clinical development, as setbacks in one program may be offset by progress in others. This diversification can also create multiple value inflection points, attracting investors seeking reduced exposure to binary outcomes while maintaining exposure to breakthrough innovation. From an M&A perspective, diversified pipelines may increase strategic appeal because acquirers gain optionality. A single acquisition can provide access to multiple therapeutic candidates, allowing pharmaceutical companies to prioritize programs based on evolving market needs or scientific progress. As the biotech industry continues to emphasize late-stage validation, platform versatility and capital efficiency, companies combining diversified clinical programs with differentiated scientific approaches may increasingly attract attention from strategic partners and acquirers seeking to balance innovation with reduced development risk. Oncotelic Therapeutics positions itself within this diversified model through a portfolio spanning oncology-focused therapies, CNS indications and delivery technologies. The company’s pipeline includes multiple assets at varying development stages, which may reduce reliance on a single program outcome while supporting broader strategic positioning. Pharma Deals Signal Strategic Shift The pharmaceutical space continues to evolve through strategic partnerships, targeted acquisitions and collaborative innovation designed to accelerate drug development and expand therapeutic pipelines. Recent announcements across the sector highlight a focus on neurological disorders, RNA-based therapies and AI-driven research approaches, reflecting how leading operators are positioning themselves to capture future growth opportunities while addressing significant unmet medical needs. Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported a global licensing and collaboration agreement with Novartis. The agreement is for ARO-SNCA, Arrowhead’s preclinical stage siRNA therapy against alpha-synuclein for the treatment of synucleinopathies, such as Parkinson’s disease, and for other additional collaboration targets that will utilize Arrowhead’s proprietary Targeted RNAi Molecule (TRiM[TM]) platform. Upon closing, Arrowhead will receive $200 million as an upfront payment and is eligible to receive up to $2 billion in potential milestone payments plus royalties on commercial sales. MeiraGTx Holdings plc (NASDAQ: MGTX) announced the formation of a joint venture with Hologen Limited. According to the announcement, MeiraGTx will receive $200 million in upfront cash at closing of the JV, called Hologen Neuro AI Ltd. In addition to the $200 million upfront payment to MeiraGTx, Hologen Neuro AI will be funded with committed capital of up to $230 million from Hologen to fully finance the development of AAV-GAD for the treatment of Parkinson’s disease through to commercialization, as well as funding earlier stage clinical programs in the CNS, including AAV-BDNF for genetic obesity. Hologen will contribute its proprietary multi-modal generative foundation models (LMMs) to the joint venture. Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) completed the acquisition of Sage Therapeutics for approximately $561 million upfront, with contingent value rights (CVR) that could bring total consideration up to about $795 million. The transaction will provide Supernus with an innovative marketed product: ZURZUVAE(R) (zuranolone) capsules CIV, the first and only U.S. Food and Drug Administration (FDA)-approved oral medicine indicated for the treatment of adults with postpartum depression. Johnson & Johnson (NYSE: JNJ) has entered into a definitive agreement to acquire all outstanding shares of Intra-Cellular Therapies in a $14.6 billion transaction. Intra-Cellular Therapies is a biopharmaceutical company focused on the development and commercialization of therapeutics for CNS disorders. With this agreement, Johnson & Johnson adds Intra-Cellular Therapies’ CAPLYTA(R)(lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. These developments underscore a broader transformation underway in pharma, where collaboration, platform technologies and portfolio expansion are becoming central to long-term strategy. As companies pursue high-value deals and innovative partnerships, investors and industry observers alike are watching closely to see how these initiatives translate into clinical advancement, commercial success and sustained competitive advantage. For more information, visit Oncotelic Therapeutics profile. About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer’s filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer’s securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may,” “future,” “plan” or “planned,” “will” or “should,” “expected,” “anticipates,” “draft,” “eventually” or “projected.” You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWireAustin, Texaswww.BioMedWire.com512.354.7000 OfficeEditor@BioMedWire.comBioMedWire is powered by IBN

CAPLYTA® nearly doubled the likelihood of remission at six weeks compared to placebo as an adjunctive therapy to an antidepressant based on pooled data from two Phase 3 studies 65% of patients reached remission with CAPLYTA®, with 43% achieving sustained relief from symptoms, in a six-month open-label extension safety study Newly approved as an adjunctive for major depressive disorder, CAPLYTA® supports the ultimate treatment goal of remission with robust short-term data and long-term open-label safety data TITUSVILLE, N.J., Jan. 16, 2026 /PRNewswire/ -- Johnson & Johnson today announced a new analysis of Phase 3 data which found CAPLYTA® (lumateperone), in combination with an antidepressant, showed significantly greater remission rates in adults with major depressive disorder (MDD) than placebo plus an antidepressant at six weeks, with continued benefits observed through six months in an open-label extension study. The findings are featured in one of 11 abstracts from across Johnson & Johnson's neuropsychiatry portfolio that were presented at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from January 12-15, in Nassau, Bahamas. MDD is one of the most common psychiatric disorders, affecting about 22 million American adults.1,2 While remission – relief from depressive symptoms – is the ultimate goal of treatment, nearly two-thirds of patients do not achieve it with available therapies. Patients with residual symptoms experience prolonged psychosocial impairment, higher relapse risk and overall reduced quality of life.3 Beyond its toll on patients' well-being, MDD has a substantial economic burden and is the leading cause of disability in the U.S.4 CAPLYTA ® may help patients achieve the goal of remission To evaluate how CAPLYTA® may help patients achieve the goal of remission, the analysis draws from three Phase 3 CAPLYTA® studies, including pooled data from two pivotal efficacy and safety trials (Studies 501 and 502) and a six-month open-label extension safety study (Study 503).5,6,7 The analysis evaluated three measures of remission, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS): remission (defined as MADRS ≤10), complete remission (defined as MADRS ≤5), and sustained remission (defined as MADRS ≤10 maintained at each assessment) to assess the potential resolution and durability of relief from symptoms. Across all three measures, CAPLYTA® demonstrated meaningful remission rates, highlighting both the depth and durability of improvement for patients living with MDD. "Today, remission is out of reach for the majority of patients with depression, which means they continue to struggle with persistent symptoms that negatively impact their daily lives," said Michael E. Thase, M.D., Professor of Psychiatry and Chief, Division of Mood and Anxiety Disorders Treatment & Research Program, Perelman School of Medicine at University of Pennsylvania.8,9,a "These data capture not only symptom reduction, but also the durability and depth of treatment response, which are critical benchmarks for patients and clinicians striving for lasting relief. The findings demonstrate that adjunctive lumateperone may almost double the likelihood of remission, with benefits sustained over six months, offering renewed hope to millions of adults seeking recovery from this disease.1,2" Detailed study findings In the pooled pivotal data, almost twice as many patients reached remission (MADRS ≤10) at six weeks with adjunctive CAPLYTA® compared to placebo (25.5 percent versus 13.6 percent; nominal p<0.0001), with 10.6 percent of patients achieving complete remission (MADRS ≤5) with CAPLYTA® plus an antidepressant compared to 5.6 percent with placebo plus an antidepressant (p<0.01). At six weeks, significantly greater remission rates with CAPLYTA® versus placebo were consistent across patient subgroups, including age, antidepressant type (SSRI/SNRI), and baseline severity. In Study 503, a six-month open-label extension safety study (n = 809), efficacy was maintained with long-term CAPLYTA® treatment, with nearly two out of three patients (65.4 percent; n = 529) reaching remission (MADRS ≤10). Complete remission (MADRS ≤5) was reached by 44.1 percent (n = 357) of patients. Notably, almost half of patients (42.8 percent; n = 346) experienced sustained remission (MADRS ≤10 at each assessment) by the end of treatment, with rates increasing steadily throughout the study: Week 8 (28.6 percent; n = 231), Week 16 (37.2 percent; n = 301), and Week 24 (40.8 percent; n = 330). Remission rates were consistent across patient subgroups, including age, antidepressant type (SSRI/SNRI), and baseline severity. "What matters most to patients isn't just an improvement in symptoms, but sustained relief that allows them to truly reclaim their lives," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "Too many patients spend years cycling through treatments, settling for 'good enough' because they don't realize complete relief is possible. These data demonstrate that remission is within reach and should be the expectation, not the exception." CAPLYTA® was recently approved by the U.S. Food and Drug Association (FDA) in November 2025 as an adjunctive therapy for MDD and is also indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder. While the mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and moderate amounts of dopamine D2 receptor occupancy at therapeutic doses. CAPLYTA® does not need dose titration, allowing patients to start treatment at the effective dose of 42 mg.3,10 A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was submitted to the FDA. The medication is also being studied for other neuropsychiatric disorders. CAPLYTA® is not FDA-approved for these disorders. This press release is not sanctioned by ACNP. Editor's note: a Michael E. Thase, M.D. has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Major Depressive Disorder (MDD) MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people – or about 4 percent of the population.1 In the U.S. alone, about 22 million adults are living with the disease.2 While depression is typically treated with a "one-size-fits-all" approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations. As a result, responses to treatment vary widely.11,12 Only 1 in 3 patients reach remission with their first antidepressant, and rates continue to decline further with each subsequent treatment – leaving many to spend years cycling through multiple treatments trying to find complete, sustained symptom relief.8,9 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.13 About Study 501 and Study 502 Studies 501 and 502 are two positive Phase 3 global, double-blind, placebo-controlled studies in patients with a primary diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who have had an inadequate response to ongoing antidepressant therapy. CAPLYTA®, added to an antidepressant, demonstrated robust efficacy for the treatment of MDD in the primary endpoint, the MADRS Total score, with a large separation versus placebo of 4.9 points (effect size 0.61) in Study 501 and 4.5 points (effect size 0.56) versus placebo in Study 502. The efficacy of CAPLYTA® is complemented with a favorable safety and tolerability profile – including a favorable metabolic, weight, and movement disorder profile. In the pooled safety data for Studies 501 and 502, the most commonly reported adverse events that were observed at a rate greater than or equal to 5% for lumateperone and greater than twice the rate of placebo were dizziness, dry mouth, somnolence/sedation, nausea, fatigue, and diarrhea. Importantly, metabolic and weight changes were similar to placebo and the rates of extrapyramidal symptoms were low. About Study 503 Study 503 is a 26-week, open-label extension study that investigated the long-term safety of adjunctive CAPLYTA® 42mg in patients who completed Study 501 or 502. The primary endpoint was safety and tolerability of CAPLYTA®, measured by adverse events (AEs), extrapyramidal symptoms (EPS), suicidality, and changes in laboratory parameters, vital signs, and electrocardiogram (ECG) measures. The secondary endpoint was improvement/maintenance of depressive symptoms, measured by MADRS Total score and CGI-S score change from Study 501 or 502 baseline to Week 26 of open-label treatment. Mean changes from baseline to end of treatment were minimal for body morphology, cardiometabolic laboratory values, prolactin levels, pulse rate, blood pressure, and ECG measures. During the 26-week safety study, 80% of patients responded to treatment and 65% of patients experienced remission (defined as MADRS Total score ≤ 10) at 6 months. No patients reported emergence of serious suicidal ideation or suicidal behavior during the study. Symptoms of depression improved as measured by mean change from baseline to Week 26 in MADRS Total score (−22.9) and CGI-S score (−2.7). About CAPLYTA ® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for major depressive disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors. INDICATIONS CAPLYTA® (lumateperone) is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. IMPORTANT SAFETY INFORMATION Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA. Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position. Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. US-CAP-2500827 Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for CAPLYTA. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2026. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to product development and the potential benefits and treatment impact of CAPLYTA® (lumateperone). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes Depressive disorder (depression). World Health Organization. Accessed November 2025. Key substance use and mental health indicators in the United States: Results from the 2023 National Survey on Drug Use and Health. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Accessed November 2025. Yang H, Gao S, Li J, et al. Remission of symptoms is not equal to functional recovery: Psychosocial functioning impairment in major depression. Front Psychiatry. 2022;13:915689. doi:10.3389/fpsyt.2022.915689 Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699. doi:10.4088/JCP.20m13699 Martin M. Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder: Results from a Randomized, Double-Blind, Phase 3 Trial. American Society of Clinical Psychopharmacology Annual Meeting; May 27-30, 2025. Poster W31 Earley W. Adjunctive Lumateperone in Patients with Major Depressive Disorder: Results from an Additional Randomized, Double-Blind, Phase 3 Trial. American College of Neuropsychopharmacology Annual Meeting; December 8-11, 2024. Poster P232 Earley W. Long-Term Adjunctive Lumateperone Treatment in Major Depressive Disorder: Results from a Six-Month Open-Label Extension Study. American Psychiatric Association Annual Meeting; May 17-21, 2025. Poster P08-063 Bhagwagar Z. Remission With Lumateperone 42 mg Adjunctive to Antidepressant Therapy in Patients With Major Depressive Disorder: Analysis of Short-Term and Long-Term Trials. American College of Neuropsychopharmacology Annual Meeting; January 12-15, 2026. Poster TH66 Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi:10.1176/ajp.2006.163. CAPLYTA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. Su YA and Si T. Progress and challenges in research of the mechanisms of anhedonia in major depressive disorder. Gen Psychiatr. 2022;35:e100724. doi:10.1136/gpsych-2021-100724 Pandya M, et al. Where in the Brain Is Depression? Curr Psychiatry Rep. 2012;14:634–642. doi:10.1007/s11920-012-0322-7 Zhu L et al. Economic burden and antidepressant treatment patterns among patients with major depressive disorder in the United States. J Manag Care Spec Pharm. 2022;28(11-a suppl):S2–S13. doi:10.18553/jmcp.2022.28.11-a.s1 SOURCE Johnson & Johnson 21% more press release views with Request a Demo