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Please find enclosed the News release

Suven Life Sciences Ltd · 530239

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Suven Life Sciences Ltd announced the completion of patient enrollment in its global Phase-3 clinical study of Masupirdine for the treatment of Agitation associated with Alzheimer's Dementia (AAD). The study was designed to randomize approximately 375 patients, but a total of 424 patients were randomized. The Last patient last visit (LPLV) is expected by end of December 2026, and topline results are expected by May 2027.

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Suven Life Sciences Ltd - 530239 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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CSD/BSE&NSE/PR/2026-2027 September 03, 2026 To To Department of Corporate Services Listing Department BSE Limited National Stock Exchange of India Limited 25th Floor, P. J. Towers, Exchange Plaza, Bandra Kurla Complex Dalal Street, Mumbai – 400001 Bandra (E), Mumbai – 400051 Scrip Code: 530239 Scrip Symbol: SUVEN Dear Sir/Madam, Sub: News Release With reference to above subject, please find enclosed News Release of our company titled “Suven Life Sciences Announces Completion of Patient Enrollment in Global Phase-3 Study of Masupirdine (SUVN-502) for Agitation Associated with Alzheimer’s Dementia (AAD)” This is for your information and record. Thanking you. Yours faithfully, For Suven Life Sciences Limited K. Sangeetha Laxmi Company Secretary Encl.: as above Suven Life Sciences Limited Registered Office: 8-2-334 I SDE Serene Chambers I 6th Floor Road No.5 I Avenue 7 Banjara Hills I Hyderabad – 500 034 I Telangana I India I CIN: L24110TG1989PLC009713 Tel: 91 40 2354 1142/ 1152 Email: info@suven.com website: www.suven.com News Release Suven Life Sciences Announces Completion of Patient Enrollment in Global Phase-3 Study of Masupirdine (SUVN-502) for Agitation Associated with Alzheimer’s Dementia (AAD) *Maupirdine Global Phase-3 study enrolment completed both in USA and Europe. *Total of 424 patients were randomized. Study was designed to randomize 375 patients. *The Last patient last visit (LPLV) is expected by end of December 2026. *Targeted Database lock (DBL) by end of March-2027. *Topline results expected by May 2027. Hyderabad, India, 03-Sept-2026 – Suven Life Sciences, a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, today announced the completion of patient enrollment in its global Phase-3 clinical study of Masupirdine for the treatment of Agitation associated with Alzheimer’s Dementia (AAD). Key Highlights of the Masupirdine Phase-3 Study: Study Design: This multicenter, randomized, double-blind, placebo-controlled Phase-3 study was conducted across sites in USA and Europe. Patients were randomized in a 1:1:1 ratio to receive Masupirdine 50 mg, Masupirdine 100 mg, or placebo once daily for 12 weeks. The primary endpoint is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items corresponding to the International Psychogeriatric Association (IPA) agitation criteria. Key secondary endpoint is the modified Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C) assessing agitation-related clinical change. Additional details are available at https://agitation-study.com, ClinicalTrials.gov: NCT05397639 and EudraCT Number: 2021-003405-22. Enrollment Details: The study was designed to randomize approximately 375 patients. As several patients were already undergoing screening when the enrollment target was reached, those who subsequently met all eligibility criteria were permitted to proceed to randomization in accordance with the protocol-defined procedures. Consequently, a total of 424 patients were randomized into the study. Safety and Tolerability: Safety data from the study is being monitored continuously, with no concerns observed to date. Suven Life Sciences Limited Registered Office: 8-2-334 I SDE Serene Chambers I 6th Floor Road No.5 I Avenue 7 Banjara Hills I Hyderabad – 500 034 I Telangana I India I CIN: L24110TG1989PLC009713 Tel: 91 40 2354 1142/ 1152 Email: info@suven.com website: www.suven.com Management Perspective: “We are pleased to announce that we have completed the enrollment for our Masupirdine Phase-3 clinical study. The strong enrollment in the Masupirdine trial highlights the significant unmet need for new treatment options for the management of Agitation associated with Alzheimer's disease. We are grateful for the enthusiasm and commitment of the study participants, caregivers, investigators, and site staff, whose dedication contributed to the efficient conduct of the trial. We remain very optimistic of completion of this study with definitive timelines and look forward to bring a new therapy to AAD” said Mr. Venkat Jasti, Chairman and Managing Director, Suven Life Sciences. “Masupirdine is a highly selective 5-HT receptor antagonist with a differentiated pharmacological profile and has demonstrated a favorable efficacy and tolerability profile throughout its non-clinical and clinical development. Current pharmacological approaches to the management of agitation associated with Alzheimer’s dementia rely predominantly on sedative mechanisms or antipsychotic agents. Sedation and the adverse-effect profile associated with antipsychotics, including potential cardiac risks present significant limitations, particularly in this vulnerable patient population. Masupirdine, with its distinct and novel mechanism of action, has the potential to address several of these limitations and provide meaningful differentiation from existing treatment options,” said Ramakrishna Nirogi, President and Chief Scientific Officer, Suven Life Sciences. Agitation in Alzheimer’s Disease (AAD): Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by a range of neuropsychiatric symptoms. Among these, agitation is one of the most distressing and challenging symptoms for both patients and caregivers, contributing substantially to early institutionalization, increased morbidity, caregiver burden, and functional impairment. Despite its significant clinical impact, there remains a substantial unmet need for effective and well-tolerated treatment options for the management of agitation in patients with AD. Masupirdine: Masupirdine is a potent and highly selective 5-HT receptor antagonist with favorable pharmacokinetic properties. In preclinical studies, Masupirdine attenuated aggressive behaviors and modulated neurotransmitter pathways implicated in neuropsychiatric symptoms. In a clinical study, Masupirdine demonstrated a reduction in agitation and aggression in patients with AD. Suven Life Sciences Limited Registered Office: 8-2-334 I SDE Serene Chambers I 6th Floor Road No.5 I Avenue 7 Banjara Hills I Hyderabad – 500 034 I Telangana I India I CIN: L24110TG1989PLC009713 Tel: 91 40 2354 1142/ 1152 Email: info@suven.com website: www.suven.com About Suven Life Sciences: Suven Life Sciences Limited (Suven) is focused on the discovery and clinical development of innovative medicines that address unmet medical needs in CNS disorders. We have portfolio of advanced stage clinical candidates and research programs that are designed for CNS disorders such as Alzheimer’s disease (AD), Sleep disorders, Major depressive disorders (MDD), Parkinson’s disease (PD), Schizophrenia, Pain disorders, and Gastrointestinal disorders. Suven has 5 clinical stage assets across focus areas: Masupirdine (SUVN-502) for the treatment of agitation in patients with dementia of the Alzheimer's type (Global Phase-3 study ongoing, enrollment completed); Samelisant (SUVN-G3031) for excessive daytime sleepiness (EDS) in narcolepsy (Phase-2 study for EDS completed; pivotal Phase-3 AWAKE study for EDS is initiated and Phase-2 study for Cataplexy is in planning); Ropanicant (SUVN-911) for MDD (Open-label Phase-2a study completed; Double blind randomized Placebo controlled Phase-2b study completed and Phase-3 study is in planning); Usmarapride (SUVN-D4010) for cognitive disorders (Phase-2 study in planning), SUVN-I6107 for cognitive disorders (Phase-1 study is completed and Phase-2 enabling safety studies are in planning). In addition to these clinical assets, we have 7 projects in research pipeline across multiple indications. Suven owns all intellectual property rights for its assets in all major world markets. For more information, please visit our website http://www.suven.com. Risk Statement: Except for historical information, all the statements, expectations, and assumptions, including expectations and assumptions, con [Showing first 8,000 characters — download PDF for full document]