CSD/BSE&NSE/PR/2026-2027 June 4, 2026
To Department of Corporate Services BSE Limited 25th Floor, P. J. Towers, Dalal Street, Mumbai - 400001 To Listing Department National Stock Exchange of India Limited Exchange Plaza, Bandra Kurla Complex Bandra (E), Mumbai - 400051 Scrip Code: 530239 Scrip Symbol: SUVENDear Sir/Madam,
With reference to above subject, please find enclosed News Release of our company titled "Suven Life Sciences Reports Positive DSMB Safety Review and Interim Analysis from Ongoing Global Phase 3 Study of Masupirdine in Alzheimer's Disease Agitation at 50% study completers - Study to Continue Unchanged"
This is for your information and record. Thanking you.
Yours faithfully,
For Suven Life Sciences Limited
Kandari Sangeetha Laxmi
Digitally signed by Kandari Sangeetha Laxmi
Date: 2026.06.04
10:41:01 +05'30'
K. Sangeetha LaxmiCompany Secretary Encl.: as above
News Release Suven Life Sciences Reports Positive DSMB Safety Review and Interim Analysis from Ongoing Global Phase 3 Study of Masupirdine in Alzheimer's Disease Agitation at 50% study completers - Study to Continue Unchanged.Hyderabad, India (4-June-2026): Suven Life Sciences, a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, today announced positive outcomes from an independent Data and Safety Monitoring Board (DSMB) review and a pre-specified Interim Analysis of its ongoing global Phase 3 study evaluating Masupirdine (SUVN-502) for the treatment of agitation associated with Alzheimer's disease (AD).
The DSMB conducted a planned safety review after approximately 50% of randomized participants who had completed the 12 weeks of treatment. Based on a comprehensive evaluation of the unblinded safety data, the DSMB recommended that the trial to continue as planned and no modifications to the study design or conduct. No safety concerns were identified that would warrant any changes to the protocol or any additional follow up needed.
In parallel, a pre-specified unblinded interim analysis was performed to assess sample size adequacy after approximately 50% of participants who had completed the 12 weeks of treatment period. Based on the analysis, DSMB recommended that no increase in sample size, supporting continuation of the trial as originally planned.
Enrollment continues to progress strongly, with approximately 88% of the planned patient population enrolled as on date. Based on the current enrollment trajectory, Suven expects to complete enrollment by the September 2026. Last patient last visit is anticipated in January 2027, with database lock and top-line results expected in Q2-2027. Given the continued acceleration in enrollment, the Company believes there is a potential to further advance these timelines.
"We are pleased to report another positive safety review for Masupirdine, with the DSMB recommending continuation of the trial without modification, marking a key milestone in its development. To date, over 88% of study participants have been enrolled, reflecting strong execution and sustained momentum. We remain fully committed to the program, with patient enrolment on track for completion by the end of calendar year 2026," said Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences.
About Masupirdine Agitation Study: The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study conducted across approximately 80 sites in North America (USA) and Europe (Poland, Serbia and Croatia). Approximately 375 patients will be randomized 1:1:1 to receive Masupirdine 50 mg QD, 100 mg QD, or Placebo for 12 weeks. The primary endpoint is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items aligned with 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) related to agitation.
Additional details are available https://agitation-study.com, at ClinicalTrials.gov NCT05397639 and at EudraCT Number 2021-003405-22.
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); Samelisant (SUVN-G3031) for excessive daytime sleepiness (EDS) in narcolepsy (Phase-2 study for EDS completed; Phase-2 study for Cataplexy and pivotal Phase-3 study for EDS are in planning); Ropanicant (SUVN-911) for MDD (Open-label Phase-2a study completed; Double blind randomized Placebo controlled Phase-2b study ongoing); Usmarapride (SUVN-D4010) for cognitive disorders (Phase-2 study in planning), SUVN-I6107 for cognitive disorders (Phase-1 study in progress). In addition to these clinical assets, we have7 projects in research pipeline across multiple indications. Suven owns all intellectual property rights for its assets in all major 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, contained in this news release may be forward-looking statements that involve several risks and uncertainties. Although Suven attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Other important factors which could cause results to differ materially including outsourcing trends, economic conditions, dependence on collaborative partnership programs, retention of key personnel, technological advances, and continued success in growth of sales that may make our products/services offerings less competitive; Suven may not undertake to update any forward-looking statements that may be made from time to time.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