A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Start Date11 Sep 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07284745

/ Not yet recruitingPhase 3

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Start Date11 Sep 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07423546

/ Not yet recruitingPhase 1/2IIT

A Multimodal PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. [18F]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission.
The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by [18F]DOPA Kicer ([18F]DOPA relative uptake rate)).

Start Date01 Apr 2026

Sponsor / Collaborator

The New York State Psychiatric Institute

[+1]

100 Clinical Results associated with Xanomeline Tartrate/Trospium Chloride

100 Translational Medicine associated with Xanomeline Tartrate/Trospium Chloride

100 Patents (Medical) associated with Xanomeline Tartrate/Trospium Chloride

Literatures (Medical) associated with Xanomeline Tartrate/Trospium Chloride

01 Mar 2026·CNS DRUGS

New Pharmacological Treatment Approaches for Schizophrenia: Navigating the Post-iclepertin Landscape

Review

Author: Englisch, Susanne ; Zink, Mathias

Schizophrenia is a complex psychiatric disorder, with cognitive impairment representing a critical unmet medical need. Current treatments primarily address positive symptoms, failing to effectively improve cognitive function and negative symptoms. This narrative review examines the current landscape of novel schizophrenia therapeutics following the discontinuation of iclepertin development, critically evaluates the most promising current candidates, and identifies priority research areas for future drug development. A comprehensive literature review was conducted covering developments from 2020 to 2025, with emphasis on Phase II and Phase III clinical data for novel mechanisms beyond traditional dopamine D₂ receptor antagonism. The landscape has been dramatically reshaped by two pivotal developments: the U.S. Food and Drug Administration (FDA) approval of xanomeline/trospium (KarXT, Cobenfy^®) in September 2024 as the first nondopaminergic antipsychotic, and the failure of iclepertin in Phase III trials in January 2025. The most compelling therapeutic approaches continue to be serotonin-dopamine activity modulators (brilaroxazine) and emerging M₄ selective agonists (NBI-1117568). Moreover, recent evidence suggests a more cautious outlook for TAAR1 agonists, with systematic analyses revealing significant placebo response challenges in recent trials. While iclepertin's discontinuation represents a significant setback for GlyT1 inhibition strategies, the approval of KarXT and advancing pipeline candidates offer potential for therapeutic advances. Critical challenges include escalating placebo responses that compromise trial assay sensitivity, underscoring the need for improved patient stratification, refined trial methodology, and outcome measures that accurately capture real-world benefit.

01 Mar 2026·JOURNAL OF ECT

Safe, Repeated Treatment With Electroconvulsive Therapy in Combination With KarXT

Article

Author: Sanghani, Sohag N ; Andrus, Jason M

Abstract:

To our knowledge, no report has been made of safe concurrent treatment with the novel muscarinic antipsychotic agent KarXT and electroconvulsive therapy (ECT). The drug has the potential for influencing the ECT procedure as well as outcomes. These issues are explored in the context of a case in which KarXT and ECT were successfully combined safely and repeatedly.

01 Mar 2026·Spanish journal of psychiatry and mental health

New Interventions for Schizophrenia: Navigating the Treatment Landscape

Article

Author: McCutcheon, Robert A ; Fernandez-Egea, Emilio

For over half a century, antipsychotic efficacy for schizophrenia treatment has been tied to dopamine D2 receptor antagonism, with predictable trade-offs: limited impact on negative and cognitive symptoms, and substantial metabolic, endocrine, and motor adverse effects. In the past few years, schizophrenia drug development has re-accelerated, including the first US approval of a non-D2 antipsychotic mechanism (xanomeline-trospium), and several late-stage programmes aiming to treat symptom domains that matter most to long-term functioning. At the same time, several high-profile "dopamine-sparing" agents have failed in phase 2 and 3 trials, underscoring that mechanistic novelty alone is insufficient. Successful translation requires alignment among biological targets, trial design, and patient phenotypes. In this review, we examine emerging interventions and propose a pragmatic translational framework centered on domain-specific prescribing, earlier implementation of measurement-based care, and biomarker-informed stratification.

339

News (Medical) associated with Xanomeline Tartrate/Trospium Chloride

28 Mar 2026

·www.businesswire.com

Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride)

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced data from a Phase 4 clinical trial evaluating the symptom stability, safety and tolerability of Cobenfy (xanomeline and trospium chloride) when switching adult outpatients with schizophrenia from an oral atypical antipsychotic to Cobenfy monotherapy. Through 8 weeks, patients remained stable with mean Positive and Negative Syndrome Scale (PANSS) total scores remaining below baseline, and no new safety signals were observed, regardless of cross-titration duration. These findings provide important evidence to help inform treatment switch strategies in clinical practice. Data were presented at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS) taking place March 25-29 in Florence, Italy. “While transitioning patients is common in schizophrenia, clinicians have historically had limited data to help guide these decisions, especially for differentiated treatments like Cobenfy,” said David Walling, PhD, principal investigator and chief clinical officer at Cenexel – CNS. “The data presented today provide much-needed insight into what happens during a switch to Cobenfy, notably that patients remained stable through 8 weeks of treatment regardless of a slower or faster cross-titration, which will help healthcare professionals make informed treatment decisions for adults living with schizophrenia.” This 8-week, open-label trial evaluated two cross-titration strategies in adults with schizophrenia (n=105): tapering the existing atypical antipsychotic down over the faster 2 week (n=52) or slower 4 week (n=53) period while simultaneously up-titrating Cobenfy to the target dose of 125/30 mg BID, over two weeks in both arms. Patients were required to have a PANSS total score at or below 80 at screening and baseline, Clinical Global Impression-Severity (CGI-S) score of ≤4, and to be on a stable dose of an oral atypical antipsychotic for at least 6 weeks. The primary objective of the trial was to evaluate the rate of all-cause Cobenfy discontinuation over a period of 8 weeks. Key secondary endpoints included Cobenfy discontinuation due to a lack of efficacy, incidence of, and discontinuations due to adverse events (AEs), change from baseline (CFB) to week 8 in the PANSS total score, CGI-S, Personal and Social Performance (PSP), and Medication Satisfaction Questionnaire (MSQ). In the trial, approximately 86% of patients completed 8 weeks of treatment, with discontinuation rates of 15.1% (n=8) and 13.5% (n=7) in the slower and faster transition groups. No patients discontinued treatment with Cobenfy due to lack of efficacy. Mean changes in PANSS total scores from baseline to week 8 were −4.2 in the slower transition group and −3.1 in the faster transition group. Mean change in CGI-S scores was −0.2 in both the slower and faster transition groups. From baseline to week 8, mean PSP scores improved by 1.1 and 0.7 in the slower and faster transition groups, respectively. Across both cross-titration groups, treatment with Cobenfy was generally well tolerated, with no new safety or tolerability issues emerging. In the trial, 49% of patients had ≥1 treatment-emergent adverse event (TEAE) and none were serious. TEAE rates were consistent with those reported in the EMERGENT trials. In the slower and faster transition groups, 1 (1.9%) patient and 2 (3.8%) patients, respectively, discontinued treatment early due to TEAEs. “Cobenfy represents a fundamentally different approach to treating schizophrenia as the first novel mechanism in decades, and physicians are naturally curious as to how they can switch and transition adult patients with schizophrenia to this innovative medication,” said Harald Hampel, MD, PhD, senior vice president, worldwide head of neuroscience, global medical affairs, at Bristol Myers Squibb. “We carefully designed this trial with the scientific rigor and curiosity in mind, knowing that treatment decisions are not made lightly, and patient benefit, safety and stability is our ultimate goal.” About Schizophrenia Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently, and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide. About Cobenfy™ (xanomeline and trospium chloride) Cobenfy™ (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. Cobenfy combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily confining its effects on peripheral tissues. While the exact mechanism of action of Cobenfy is unknown, its efficacy is thought to be due to the agonist activity of xanomeline at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. INDICATION COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS COBENFY is contraindicated in patients with: urinary retention moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment gastric retention history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride. untreated narrow-angle glaucoma WARNINGS AND PRECAUTIONS Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention. COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment. In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated. Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions. COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment. Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment. Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage. COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated. Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values. Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis. Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride. Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring. Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY. Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment. Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation. Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease. Use in Specific Populations: Moderate or Severe Renal Impairment: Not recommended Mild Hepatic Impairment: Not recommended COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules. Please see U.S. Full Prescribing Information, including Patient Information. About Bristol Myers Squibb: Transforming Patients’ Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” 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, that future study results may not be consistent with the results to date and that Cobenfy (xanomeline and trospium chloride) may not receive any additional regulatory approvals for the treatment of schizophrenia for adults described in this release, any marketing approvals, if granted, may have significant limitations on their use, and, whether Cobenfy will be commercially successful. 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’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, 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. corporate financial-news

Clinical ResultPhase 3Drug ApprovalPhase 2

24 Mar 2026

·allsci.com

Amani raises USD 25m Series A, in-licenses AZ compound for clozapine FDC

Amani Therapeutics, a newly formed biotechnology company based in New York, has closed a USD 25 million Series A financing round to advance AM-01, a fixed-dose combination product targeting serious neuropsychiatric disorders. The company simultaneously announced the in-licensing of worldwide rights from AstraZeneca to a Phase III-ready novel chemical entity that forms a core component of AM-01. RTW Investments, a New York-based investment firm focused on biopharmaceutical and medical technology sectors, backed the round. No other participating investors were disclosed. The company said it plans to use the proceeds to advance AM-01 toward late-stage clinical development. AM-01 combines clozapine, the only medication with demonstrated efficacy in treatment-resistant schizophrenia and suicide risk reduction in schizophrenia and schizoaffective disorder, with the AstraZeneca-derived compound. The combination is designed to preserve clozapine’s efficacy while mitigating its primary safety liability, severe neutropenia, and the mandatory blood-monitoring requirements that have limited its clinical uptake. Clozapine was developed in the late 1950s and secured first approval in the US in 1989 under Novartis ownership. The molecule remains underutilized despite its established clinical profile. The company appointed Rob Swoboda as Chief Operating Officer and Carla Canuso, MD, as Chief Medical Officer. Swoboda previously served as Senior Vice President of Corporate and Portfolio Operations at Karuna Therapeutics, where he led cross-functional work on schizophrenia drug Cobenfy (xanomeline/trospium chloride) and contributed to the company’s acquisition by Bristol Myers Squibb. He also held roles at bluebird bio and Vertex Pharmaceuticals. Canuso spent more than two decades in neuropsychiatric clinical development at Johnson & Johnson, where she served as Vice President and Head of Neuropsychiatry and led the compound development team for intranasal esketamine. She currently serves as a non-voting industry representative on the US FDA Psychopharmacologic Drugs Advisory Committee. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Executive ChangeDrug ApprovalLicense out/inAcquisitionPhase 3

26 Feb 2026

·www.biospace.com

Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates

– Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025 – Zocilurtatug pelitecan (zoci) on track to become Zai Lab’s first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026 – Advancing a differentiated global pipeline, including ZL-1503 (IL-13/IL-31Rα), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1/IL-12) and ZL-1311 (MUC17/CD3 TCE) – Key regional programs continue to advance, with KarXT approved in China and commercial launch preparations underway; pivotal data readouts for povetacicept in IgAN and elegrobart in TED expected in 2026 Conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates. “2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader.” “KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement.” Fourth Quarter and Full-Year 2025 Financial Results Total revenue was $127.6 million in the fourth quarter of 2025 and $460.2 million for the full-year 2025. Product revenue, net was $127.1 million in the fourth quarter of 2025, compared to $108.5 million for the same period in 2024, representing 17% y-o-y growth and 16% at constant exchange rate (CER); and was $457.2 million in full-year 2025, compared to $397.6 million for the same period in 2024, representing 15% y-o-y growth and 16% y-o-y growth at CER. This increase was primarily due to higher revenue for XACDURO and NUZYRA. – ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. – VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024. – XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year. – NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration. Research and Development (R&D) expenses were $61.6 million in the fourth quarter of 2025, compared to $52.3 million for the same period in 2024, and $220.9 million for full-year 2025, compared to $234.5 million for the same period in 2024. The fourth-quarter increase resulted from progress in clinical trials. The full year decline was primarily driven by lower personnel compensation due to strategic resource optimization. Selling, General and Administrative (SG&A) expenses were $73.0 million in the fourth quarter of 2025, compared to $82.6 million for the same period in 2024, and $277.6 million for full-year 2025, compared to $298.7 million for the same period in 2024. The decrease was primarily due to a reduction in general and administrative expenses due to strategic resource optimization. Loss from operations was $69.4 million and $229.4 million in the fourth quarter of 2025 and full-year 2025, respectively, and $49.6 million and $148.8 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release. Net loss was $50.4 million in the fourth quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7 million for the same period in 2024 or a loss per ordinary share of $0.08 (or loss per ADS of $0.80). The net loss was $175.5 million for full-year 2025, or a loss per ordinary share attributable to common stockholders of $0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1 million for full-year 2024, or a loss per ordinary share of $0.26 (or loss per ADS of $2.60). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses and shift from foreign currency losses to foreign currency gains, offset by decreased interest income. Cash and cash equivalents, short-term investments and current restricted cash totaled $789.6 million as of December 31, 2025, compared to $879.7 million as of December 31, 2024. 2026 Strategic Priorities Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation: Advancing Differentiated Global Programs Across Oncology and Immunology Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three registration-enabling studies across 2L+ SCLC, 1L SCLC, and other neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts expected in 2026, including: – 2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases. – 1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination. – Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study. ZL-1503 (IL-13/IL-31Rα bispecific antibody): First-in-Human (FIH) data from the ongoing global Phase 1/1b study expected in the second half of 2026, paving the way for Phase 2 development in atopic dermatitis (AD). ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing. ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug (IND)-enabling studies expected to be completed in 2026. ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected by year end. Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year. Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth VYVGART and VYVGART Hytrulo: Continue to increase patient utilization and duration of treatment in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). KarXT: Planned commercial launch in the first half of 2026, supported by a targeted commercial strategy, physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are expected to further strengthen regional revenue growth in the near term. Key Corporate Updates Below are key corporate updates since our last earnings release: Business Development: – We obtained the exclusive worldwide rights to develop and commercialize ZL‑1311, a next‑generation TCE targeting MUC17, which is a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. This program represents Zai Lab’s first globally owned TCE and strategically expands our immuno‑oncology portfolio while leveraging our established expertise in GI cancers. ZL‑1311 is expected to enter global clinical development this year. – We formed a strategic collaboration with SciClone Pharmaceuticals (SciClone) for AUGTYRO™ (repotrectinib), which was approved in mainland China for ROS1‑positive non‑small‑cell lung cancer in May 2024 and for NTRK‑positive solid tumors in January 2026. Through this collaboration, Zai Lab will leverage SciClone’s commercialization infrastructure to broaden access and accelerate the commercial rollout of this innovative therapy for patients in need across mainland China. NRDL Updates: In December 2025, Zai Lab announced the successful renewals of VYVGART (efgartigimod alfa injection) for gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, NUZYRA (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) and ZEJULA (niraparib) for platinum-sensitive, first-line and recurrent ovarian cancer patients in China’s NRDL. Recent Pipeline Highlights Below are key product candidate updates since our last earnings release: Oncology Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC): – Second-Line+ ES-SCLC: The global Phase 3 study evaluating the efficacy and safety of zoci versus investigator’s choice therapy (topotecan, lurbinectedin, or amrubicin) in patients with relapsed SCLC is ongoing. This pivotal study plans to enroll approximately 480 patients in 2L SCLC or 3L post‑tarlatamab SCLC, with the majority of enrollment anticipated to be completed this year. – Extrapulmonary NECs : In January 2026, Zai Lab dosed the first patient in the global Phase 2 portion of its ongoing Phase 1b/2 study in NECs. Zai Lab plans to present an initial data readout from the Phase 1b portion in the first half of 2026, complete enrollment for the Phase 2 portion, and advance the program into the registrational stage within the year. ZL-6201 (LRRC15 ADC): In January 2026, the FDA cleared the IND application for a global Phase 1 study in patients with sarcoma and potentially other LRRC15-positive solid tumors. The global Phase 1 study has been initiated. Tumor Treating Fields (TTFields): In February 2026, the FDA approved Optune Pax ® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. It is the first treatment approved by the FDA for locally advanced pancreatic cancer in nearly 30 years. China’s NMPA granted Innovative Medical Device Designation for the treatment of pancreatic cancer in August 2025. AUGTYRO™ (repotrectinib, ROS1/TRK): In December 2025, China’s NMPA approved the supplemental New Drug Application (sNDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Immunology, Neuroscience, and Infectious Disease Pipeline ZL-1503 (IL-13/IL-31Rα): In December 2025, Zai Lab dosed the first participant in a global Phase 1/1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503 for the treatment of AD. Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026. VYVGART (FcRn): – Ocular myasthenia gravis (oMG): Zai Lab partner argenx announced in February 2026 that the Phase 3 ADAPT OCULUS met its primary endpoint (p-value=0.012), demonstrating that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. VYVGART was well tolerated and had a favorable safety pro patients with oMG, consistent with prior studies. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). – Seronegative generalized myasthenia gravis (sn-gMG): In January 2026, the FDA accepted for Priority Review a supplemental Biologics License Application (sBLA) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) sn-gMG, with a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. Zai Lab participated in the Phase 3 ADAPT SERON study in Greater China. KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In December 2025, China’s NMPA approved the NDA for KarXT for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally new approach to treating schizophrenia. The commercial launch in China is planned for the second quarter of 2026. Povetacicept (APRIL/BAFF): In December 2025, Zai Lab joined the global pivotal Phase 2/3 OLYMPUS study in primary membranous nephropathy (pMN) and dosed the first patient in mainland China. The FDA granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation. Elegrobart (anti-IGF-1R, subcutaneous): In December 2025, Zai Lab dosed the first patient in a registrational study in thyroid eye disease (TED) in mainland China. Partner Viridian plans to report topline results from two global registrational studies in patients with active TED and chronic TED in the first half of 2026. Anticipated Major Milestones in 2026 Expected Clinical Developments and Data Readouts Global Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310) Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026. First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in the first half of 2026. Extrapulmonary NECs: Zai Lab to provide data readout from the global Phase 1b portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors in the first half of 2026 and advance into registrational development in 2026. ZL-1503 (IL-13/IL-31Rα) Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026. Regional Pipeline Upcoming Potential NMPA Approvals Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer Efgartigimod (FcRn) Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the study in Greater China. Povetacicept (APRIL/BAFF) IgA Nephropathy (IgAN) : Zai Lab partner Vertex remains on track to release interim analysis data of the global Phase 3 RAINIER study in the first half of 2026 and also complete the submission in the first half of 2026, if data from the interim analysis are supportive. The FDA has granted Breakthrough Therapy Designation for this indication. pMN: Zai Lab and partner Vertex plan to complete the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and initiate the Phase 3 portion in mid-2026. Elegrobart (anti-IGF-1R, subcutaneous) Viridian to provide topline results from the global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at . Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): Registration link for dial-in: All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company’s website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at . Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as “profitability.” These adjusted growth rates and adjusted loss from operations are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U. Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Read full story here

Phase 1Phase 3License out/inDrug ApprovalBreakthrough Therapy

100 Deals associated with Xanomeline Tartrate/Trospium Chloride

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Schizophrenia	United States	Bristol Myers Squibb Co.	26 Sep 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autistic Disorder	Phase 3	United States	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Argentina	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Australia	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Canada	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	India	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	United States	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Japan	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Argentina	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Australia	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Canada	Bristol Myers Squibb Co.	11 Sep 2026

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05919823 (UNITE-001 \| ZL-2701-001, CTgov)	Phase 3	Schizophrenia	202	trospium+KarXT+xanomeline (Double-Blind Part: KarXT)	dvyeruyons(qcccdyypjw) = ohdmrdonbx sqrizijevb (rghmypibnl, 2.122) View more	-	21 Nov 2025
				placebo+KarXT (Double-Blind Part: Placebo)	dvyeruyons(qcccdyypjw) = qwybxodcqr sqrizijevb (rghmypibnl, 2.074) View more
NCT04820309 (EMERGENT-5, CTgov)	Phase 3	Schizophrenia	566	Xanomeline and Trospium Chloride Capsules	mtjnmxtgqj = hhcdombrrk szkmbxprka (ometbkhikv, rxtocpeoqx - zpkwzzifjz) View more	-	17 Sep 2025
NCT05145413 (ARISE \| KAR-012, Company_Website) Manual	Phase 3	Schizophrenia	-	Cobenfy + APD (mITT)	minxgrmldv(wsydhfopzc) = nqrlkccwyn cpbrdguwis (rgeufyhmdf, 1.01) Not Met View more	Negative	22 Apr 2025
				Placebo + APD (mITT)	minxgrmldv(wsydhfopzc) = hljitogjqa cpbrdguwis (rgeufyhmdf, 0.98) Not Met View more
NCT04738123 \| NCT04659161 \| NCT03697252 (EMERGENT-2, Pubmed \| J Clin Psychiatry)	Not Applicable	Schizophrenia	683	Xanomeline/Trospium	mhmslpnuuf(hmpwogxgnh) = peoepihjtf hgufgcpumo (qgjihusntx ) View more	Positive	26 Feb 2025
				Placebo	mhmslpnuuf(hmpwogxgnh) = etajhwlmvq hgufgcpumo (qgjihusntx ) View more
NCT04738123 (EMERGENT-3, CTgov)	Phase 3	Schizophrenia	256	Xanomeline and Trospium Chloride Capsules (KarXT)	wwomswoubw(icebflziky) = fgddqwyjja ztwmfynkun (lsasyvzlhx, 1.584) View more	-	09 Dec 2024
				Placebo (Placebo)	wwomswoubw(icebflziky) = glpltsmfmu ztwmfynkun (lsasyvzlhx, 1.552) View more
NCT04820309 (EMERGENT-5, Company_Website) Manual	Phase 3	Schizophrenia	566	COBENFY	afdibplmri(cxezedarnb) = hpidhsqsqr idfwctvawx (tsudxbqseg ) View more	Positive	31 Oct 2024
NCT04659174 (EMERGENT-4, Company_Website) Manual	Phase 3	Schizophrenia	156	COBENFY	pzqfyodvwk(hzpicvpgwh) = ojgvvfshnl xjtwlgmqhl (txcndfgfso )	Positive	31 Oct 2024
				Placebo	-
NCT05919823 (ZL-2701-001, NEWS) Manual	Phase 3	Schizophrenia	202	KarXT	nyosaczces(amiackcxdl) = xsbazmhrkp fhwdivmhlo (fckzcqtsop ) Met View more	Positive	29 Oct 2024
				Placebo	nyosaczces(amiackcxdl) = sdxswxatvj fhwdivmhlo (fckzcqtsop ) Met View more
NCT04659174 (EMERGENT-4, CTgov)	Phase 3	Schizophrenia	152	KarXT (KarXT Arm A)	fqfmygugir = erugbrdmvm prcdfqrweg (fzrulodxkm, btkbmknczr - pvxwfvyxlu) View more	-	28 Oct 2024
				Placebo+KarXT (KarXT Arm B)	fqfmygugir = ckvbxmqigy prcdfqrweg (fzrulodxkm, ehmijgbvvd - aqoosdrpxg) View more
NCT04738123 (FDA_CDER \| Pubmed) Manual	Phase 3	Schizophrenia	234	COBENFY	wxjjahmvjb(yxgwzoofzp) = utigsvkqsz qyapxullhi (ekgpkvlxas, 1.6) View more	Positive	26 Sep 2024
				Placebo	wxjjahmvjb(yxgwzoofzp) = kaqpnspahl qyapxullhi (ekgpkvlxas, 1.6) View more

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Xanomeline Tartrate/Trospium Chloride

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