A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age - NIL

Start Date12 Mar 2026

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

[+1]

NCT07369115

/ Not yet recruitingPhase 4IIT

Intra-Cellular Therapies, Inc. / "A Randomized, Double-blind, Placebo-controlled, Single Site Study to Evaluate the Efficacy of Lumateperone for the Treatment of Major Depressive Disorder (MDD) and Early Life Trauma in Adult Patients Aged 21 to 70 Years

The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. The main questions it aims to answer are:
Aim 1: To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the treatment of patients with Major Depressive Disorder and early life abuse.
Aim 2: To assess neurocircuitry encoding of threat and reward learning as predictors of lumateperone response and as mechanisms of treatment action, and assess the change from pre-dose to post-dose of task-evoked brain activation.

Start Date01 Feb 2026

Sponsor / Collaborator

The University of Texas at Austin

CTR20254391

/ Active, not recruitingNot Applicable

甲苯磺酸卢美哌隆胶囊在空腹条件下的人体生物等效性研究

[Translation] Bioequivalence study of lumepimeperone tosylate capsules in humans under fasting conditions

主要研究目的研究空腹状态下单次口服受试制剂甲苯磺酸卢美哌隆胶囊与参比制剂甲苯磺酸卢美哌隆胶囊（CAPLYTA®）在健康成年受试者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂甲苯磺酸卢美哌隆胶囊和参比制剂“CAPLYTA®”在健康受试者中的安全性。

[Translation]

Primary Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation lumepirozoline tosylate capsules and the reference formulation lumepirozoline tosylate capsules (CAPLYTA®) in healthy adult subjects under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary Objective: To investigate the safety of the test formulation lumepirozoline tosylate capsules and the reference formulation CAPLYTA® in healthy subjects.

Start Date12 Jan 2026

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

123

Literatures (Medical) associated with Lumateperone Tosylate

01 Mar 2026·INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY

Long-term safety and tolerability of lumateperone 42 mg in patients with bipolar disorder: results from a 6-month open-label extension study

Article

Author: Kozauer, Susan G. ; Tohen, Mauricio ; Davis, Robert E. ; Mates, Sharon ; Durgam, Suresh ; Chen, Changzheng

This 6-month open-label extension (OLE) period of a Phase 3 placebo-controlled study (NCT02600494) examined the safety of lumateperone in patients with bipolar I or bipolar II depression. Eligible patients completing the placebo-controlled period received lumateperone 42 mg once daily up to 175 days. The primary endpoint was safety and tolerability, assessed by adverse events (AEs) and clinical laboratory evaluations analyzed by imputing missing data using a last observation carried forward approach. The secondary endpoint was efficacy measured by Montgomery-Åsberg Depression Rating Scale (MADRS) total and Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) scores. Of 127 patients in the OLE, 58.3% completed treatment, and 42.5% experienced a drug-related treatment-emergent AE (TEAE); the most common TEAEs were headache (20.5%), dry mouth (11.8%), dizziness (10.2%), and nausea (10.2%). The majority (92%) of TEAEs were of mild or moderate severity. There were no notable changes in extrapyramidal symptom scores, cardiometabolic parameters, or body morphology. MADRS total score (mean change, −8.9, nominal P < 0.0001), CGI-BP-S total score (−2.3, nominal P < 0.0001), and CGI-BP-S depression subscore (−1.3, nominal P < 0.0001) improved over time, from baseline to Day 175. Overall, 6-month lumateperone 42 mg was generally well tolerated, and depressive symptoms based on MADRS total score and CGI-BP-S improved over time.

21 Jan 2026·Central nervous system agents in medicinal chemistry

Clinical Effects of Recently Developed Antipsychotic Drugs in Schizophrenia

Article

Author: Coveñas, Rafael ; Werner, Felix-Martin

Introduction::

Schizophrenia and schizoaffective disorder are generally treated with second- generation antipsychotic drugs. These drugs are mostly dopaminergic (D2) and serotonergic (5-HT2A) antagonists. They sufficiently improve positive schizophrenia symptoms; however, they ameliorate negative symptoms and cognitive functions only to a limited extent.

Material and Methods::

We review novel antipsychotic drugs that exert partial agonism at dopaminergic and serotonergic receptors, such as cariprazine, brexpiprazole, and lumateperone. In addition, the mechanisms of action of non-dopaminergic antipsychotic drugs are described. Updated neural network models are used to explain the mechanisms of action of muscarinic (M4 and M1) receptor agonists (e.g., xanomeline combined with trospium) and trace-amine-associated receptor 1 (TAAR1) agonists (e.g., ulotaront). Phase 3 clinical trials of new third-generation antipsychotic drugs are also presented.

Results::

Novel antipsychotic drugs with partial agonism at D2 and D3 receptors improve positive and negative schizophrenia symptoms, as well as cognitive symptoms, more effectively than second- generation antipsychotic drugs. They are also well tolerated. M4 and M1 receptor agonists (i.e., xanomeline combined with trospium or emraclidine) and TAAR1 agonists (i.e., ulotaront) substantially improve negative schizophrenia symptoms and cognitive functions. These new nondopaminergic antipsychotic drugs better ameliorate negative symptoms and improve cognitive functions compared with second-generation antipsychotic drugs.

Discussion::

Results from phase 3 clinical studies indicate the clinical efficacy of new thirdgeneration antipsychotic drugs.

Conclusion::

Promising new antipsychotic drugs include cariprazine, brexpiprazole, lumateperone, ulotaront, and xanomeline combined with trospium. Phase 3 clinical studies have shown therapeutic effects superior to those achieved with second-generation antipsychotic drugs.

01 Jan 2026·Analytical and Bioanalytical Chemistry

Volumetric absorptive microsampling for lumateperone analysis: method validation and stability evaluation

Article

Author: Milandri, Elisa ; Mandrioli, Roberto ; Iattoni, Chiara Pia ; Protti, Michele ; Vovk, Tomaž ; Mercolini, Laura ; Di Lecce, Roberta ; Armirotti, Andrea

Abstract:

Lumateperone is a recently approved atypical antipsychotic for the treatment of schizophrenia, with moderate adverse effects. However, the risk of toxicity, mainly due to possible multidrug coadministration, makes the therapeutic drug monitoring (TDM) approach crucial for developing personalised therapies and reducing side effects. In the TDM research field, microsampling represents an innovative and effective approach based on the collection and analysis of small sample volumes (< 100 μL), exhibiting many advantages (such as enhanced analyte stability, minimally invasive procedures and simplified sample storage and transport) and improving patient adherence. For the first time, an analytical methodology based on microsampling was developed and fully validated for the analysis of lumateperone in capillary blood microsamples, by means of volumetric absorptive microsampling (VAMS) in comparison with plasma analysis, with the future perspective of supporting the TDM of psychiatric patients. A reliable and streamlined VAMS protocol was optimised, and an original HPLC–MS/MS method was developed and validated, granting satisfactory results on simulated samples in terms of linearity, precision, extraction yield and matrix effect. Method reliability was successfully tested by comparing the VAMS performance with standard in-tube fluid plasma, and short- and medium-term comparative stability assays confirmed the enhancement of analyte stability obtained in dried microsamples with respect to plasma samples. This is the first analytical method based on microsampling able to provide reliable data when compared to plasma analysis and promising for future TDM applications in patients treated with lumateperone, thus offering significant advantages over conventional blood/plasma sampling in terms of collection, storage and processing.Graphical abstract

143

News (Medical) associated with Lumateperone Tosylate

17 Feb 2026

·www.globenewswire.com

Why Late-Stage CNS, Oncology Assets Are Becoming the Hottest Targets in Biotech M&A

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. 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AcquisitionLicense out/inDrug Approval

22 Jan 2026

·www.fiercepharma.com

Lundbeck ‘not willing to compromise’ on M&A strategy after missed Avadel attempt: exec

Lundbeck is bracing for the expected U.S. loss of exclusivity for its top-selling drug Rexulti at the end of 2028. Despite falling short in its recent bid to snatch Avadel from Alkermes, Lundbeck is signaling to investors that it’s not desperate for deals and will not lower its standards for future M&A. Even as some analysts question the company’s midterm prospects following a major patent cliff, leadership says it will prioritize strategic fit and financial discipline over a quick fix.“We’re not willing to compromise,” Maria Alfaiate, Lundbeck’s EVP of corporate, portfolio and product strategy, said in an interview with Fierce Pharma on the sidelines of the J.P. Morgan Healthcare Conference 2026 in San Francisco.The biggest threat to Lundbeck’s business is perhaps the expected U.S. loss of exclusivity for Rexulti at the end of 2028. The Otsuka-partnered atypical antipsychotic is currently Lundbeck’s top-selling product, with 4.7 billion Danish kroner ($737 million) in sales for the first nine months of 2025, representing 26% year-over-year growth at constant exchange rates.Lundbeck’s own projection foretells a revenue plateau in 2029 and 2030, followed by accelerated growth if a couple of its pipeline products launch successfully, Thomas Gibbs, EVP and head of Lundbeck U.S., said. That long-term view underpins the company’s unwillingness to rush into subpar deals.“We would rather accept this plateau to then grow than actually compromise,” Alfaiate added. Gibbs described “programmatic business development” as a key strategy, saying Lundbeck is now in a position where it does not need to pursue a large acquisition.As to the unsolicited bid for Avadel, “we do see that there could be some benefit in terms of either a late-stage or on-the-market asset to help address that 2029-2030 gap,” Gibbs said.After Alkermes increased its offer for Avadel in response to Lundbeck’s unsolicited bid, Lundbeck did not raise its price further.Buying Avadel would have given Lundbeck an immediate revenue stream from the commercial narcolepsy drug Lumryz and an earlier entry into neuro rare disease, “but not at any cost,” Alfaiate said. “Ultimately, walking away, I believe, shows discipline.”But some analysts appear more concerned about Lundbeck’s post-Rexulti life and see a more urgent need for M&A.“Lundbeck has an intriguing pipeline, however potential market entry is 2028+E, and thus will not address the impact of Rexulti LoE in 2029E,” Jefferies analysts wrote in a November note.The Danish pharma is currently banking on growth from Rexulti and its anti-CGRP migraine drug Vyepti, while two late-stage programs—multiple system atrophy candidate amlenetug and bexicaserin for epilepsy disorders—could enter the market around the 2028 timeframe.Rexulti is facing big-name competition from Bristol Myers Squibb’s Cobenfy in schizophrenia and Johnson & Johnson’s Caplyta in major depressive disorder (MDD), and Axsome Therapeutics’ Auvelity is approved in MDD and gunning for an expansion into Alzheimer’s disease agitation.Schizophrenia only makes up about 7.9% of Rexulti’s revenue, while MDD represents 35%. Acknowledging that it’s still early days, Gibbs said Lundbeck has not yet detected an impact from Caplyta’s launch since November. In both MDD and Alzheimer’s disease agitation, Gibbs argued that more products being available could raise awareness, drive diagnosis and overall market growth. Lundbeck and Otsuka recently failed to convince the FDA of Rexulti’s value as a treatment for post-traumatic stress disorder because of mixed data across three clinical trials. According to Gibbs, the pair will not pursue the indication further with another trial as the FDA has suggested.“I think the data package that we submitted was probably, in totality, the best data that have been generated for patients who haven’t responded to [selective serotonin reuptake inhibitors],” Gibbs said. “When you look at the time for payback, it just doesn’t make sense to do anything else.”In 2024, Lundbeck handed responsibilities for its older MDD drug, Trintellix, to partner Takeda. The Danish pharma made the move to “disproportionately allocate resources to our biggest growth drivers,” including Rexulti, Gibbs said, rather than a product that’s slated to lose patent protection in 2026.“As elegant as we tried to be with co-positioning, what our data and analytics suggested is that when our sales force was promoting Rexulti and Trintellix at the same time, we had a 20% less productivity in terms of our impact on Rexulti versus when it was done alone,” Gibbs said. Following the separation, Rexulti’s year-on-year revenue growth reached 26% in the first nine months of 2025, versus 16% during the same period in 2024, without adding any new indications.As for Vyepti, the infused anti-CGRP therapy has gained traction in a market crowded with subcutaneous injectables and oral options. The drug’s sales rose 57% at constant currencies to nearly 3.3 billion Danish kroner ($518 million) in the first three quarters of 2025. Lundbeck has pegged Vyepti’s peak annual sales at more than $1.4 billion, including $1.1 billion in the U.S.Gibbs attributed Vyepti’s success to an infusion network, which helps patients navigate the entire treatment journey, as well as Lundbeck’s continued effort in building out Vyepti’s data package. The company recently rolled out real-world data suggesting that many patients may enjoy additional benefits from the infused drug following treatment with subcutaneous anti-CGRP therapy.In the pipeline, Lundbeck got bexicaserin through its $2.5 billion acquisition of Longboard Pharmaceuticals. With two phase 3 trials running in parallel in Dravet syndrome and other developmental and epileptic encephalopathy, the 5HT2C agonist is targeting a broad label and a potential market opportunity between $1.5 billion and $2 billion globally. The Longboard buyout fits Lundbeck’s focus on neuropsychiatry, neuro specialty and neuro rare disease; and according to Gibbs, any potential deals will have to fall within that bucket.“We’re not going to buy revenue,” Gibbs added. “It’s got to be a strategic fit that ideally has both revenue and a pipeline associated with it.”That means Lundbeck is not interested in obesity, despite the brain’s involvement in the disorder. Some biotechs have been looking to tackle obesity from a neurological perspective. Neurocrine Biosciences, another major neuroscience drug developer, just unveiled an obesity pipeline.“We’re a mid-size company,” Alfaiate said. “We need to be focused and follow the science in areas where we really understand the biology and where we can have the biggest impact.”“Sometimes in science, you do have some serendipity involved,” the strategy chief continued. “If that were to happen, this is probably something where we would partner with someone who knows what they’re doing, rather than trying to do it ourselves. We remain focused and dedicated to true brain health.”

AcquisitionDrug ApprovalPhase 3

22 Jan 2026

·www.pharmaceutical-technology.com

Johnson & Johnson reports 9.1% increase in sales for Q4 2025

J&J forecasts 2026 sales of $100.5bn and adjusted EPS of $11.53 at the midpoint. Credit: PixelBiss / Shutterstock.com. Johnson & Johnson (J&J) has reported a 9.1% increase in sales for Q4 2025, reaching $24.56bn, with net earnings rising by 49.1% to $5.11bn. For the entire year, sales grew by 6% to $94.2bn, and full-year earnings per share (EPS) registered at $11.03. The diluted earnings per share (EPS) for Q4 2025 stood at $2.10, up from $1.41 in Q4 2024, reflecting a 48.9% growth. Additionally, the adjusted net earnings were reported at $6.1bn, up by 21.5% from $4.94bn in the same period of the prior year. Adjusted diluted EPS increased to $2.46 from the previous year’s $2.04, translating to a 20.6% growth. Throughout the year, significant innovations included approvals for Caplyta in treating major depressive disorder and Rybrevant Faspro plus Lazcluze for non-small cell lung cancer. J&J also announced its guidance for 2026, forecasting estimated reported sales of $100.5bn and an adjusted EPS of $11.53 at the midpoint. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Operational sales of the global innovative medicine sector increased 5.3%, bolstered by products such as Erleada, Darzalex, Carvykti in oncology, and Tremfya in immunology, among others. Medtech also saw a worldwide operational sales increase of 5.4%, driven mainly by electrophysiology products and Abiomed in cardiovascular and wound closure products in general surgery. J&J chairman and CEO Joaquin Duato said: “2025 was a catapult year for Johnson & Johnson, fuelled by the strongest portfolio and pipeline in our history. “Last year kicked off a new era of accelerated growth, driven by medical innovation that is transforming lives in our six key businesses: oncology, immunology, neuroscience, cardiovascular, surgery, and vision. In each of these important areas, our leadership is expanding, driven by game-changing science and technology.” In December 2025, J&J completed its acquisition of Halda Therapeutics, a clinical-stage biotechnology company, for $3.05bn in cash.

AcquisitionDrug ApprovalFinancial Statement

100 Deals associated with Lumateperone Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11170	Lumateperone Tosylate	N05A	DB06077

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder	United States	Johnson & Johnson	07 Nov 2025
Depressive Disorder, Major	United States	Intra-Cellular Therapies, Inc.	05 Nov 2025
Bipolar Disorder	United States	Intra-Cellular Therapies, Inc.	17 Dec 2021
Schizophrenia	United States	Intra-Cellular Therapies, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable Mood	Phase 3	United States	Intra-Cellular Therapies, Inc.	22 Nov 2024
Bipolar I disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Bulgaria	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Croatia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	India	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Bulgaria	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Croatia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	India	Intra-Cellular Therapies, Inc.	19 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04779177 (CTgov)	Phase 1	Schizoaffective disorder \| Schizophrenia	26	Lumateperone 42 mg	vakaocqwwl(ntghufopbr) = kplpntrzwt srifspcnzb (ruujuwqaxk, 11.21) View more	-	12 Nov 2025
NCT02600494 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	554	Placebo	rpeokcdkps(qsustbwzup) = rfgxamufwm fxajenzawu (caazmxgfdr, 1.11) View more	-	03 Nov 2025
NCT05061719 (CTgov)	Phase 3	Depressive Disorder, Major	812	Lumateperone	redbhjhhgo = vzlpxgmfda dtfbccdihp (lycihjlgsw, wvzgwjduaq - nxvmuwzxqi) View more	-	03 Nov 2025
NCT01499563 (CTgov)	Phase 2	Schizophrenia	335	Placebo	stknnkbjmc(ryoozagwoq) = imwrybhqfw nnmmvbinfn (rmognkdllx, 1.7) View more	-	03 Oct 2025
NCT02469155 (CTgov)	Phase 3	Schizophrenia	696	ITI-007 (Lumateperone 14 mg (ITI-007 20 mg Tosylate))	uachbbgvom(clxzudpwlm) = nhewzfvcvx yebzpztjhg (ugrurkrtce, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	uachbbgvom(clxzudpwlm) = fnhpwmhujx yebzpztjhg (ugrurkrtce, 1.23) View more
NCT02282761 (CTgov)	Phase 3	Schizophrenia	450	ITI-007 (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	pltzchxqza(espbpvpvhv) = vyjkpuejem nzjohopkgt (wnmxusgbyo, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	pltzchxqza(espbpvpvhv) = kbnmigktnc nzjohopkgt (wnmxusgbyo, 1.25) View more
NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	ebtgekkbcq(fusarstcxm) = pblqnzlxvz oubupprheb (atblydcvzs, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	ebtgekkbcq(fusarstcxm) = jghvlwmsln oubupprheb (atblydcvzs, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	uqqygnouzr(grrouiqveb) = fpxjzmuxsk gxnewdtsel (xteenbssko, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	uqqygnouzr(grrouiqveb) = oxvkpsrfxy gxnewdtsel (xteenbssko, 0.54) View more
NCT04285515 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	488	Lumateperone (Lumateperone 42mg)	wvqnnlkchd(cglkvenmji) = qpcvrplsis hnrhjbgisu (ykorbgnyck, 0.71) View more	-	19 Mar 2025
				Placebos (Placebo)	wvqnnlkchd(cglkvenmji) = keadzvcxvf hnrhjbgisu (ykorbgnyck, 0.70) View more
NCT04959032 (Company_Website) Manual	Phase 3	Schizophrenia	228	Lumateperone 42 mg	meauclfkdx(wraevuzodf) = hdodlzobdp qqddqmfklo (fktrsfejfx ) Met	Positive	05 Nov 2024
				Placebo	meauclfkdx(wraevuzodf) = ofiphrrrma qqddqmfklo (fktrsfejfx ) Met

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