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Suven Life Sciences Ltd. Regulatory Filings 2026

May 12, 2026

61491_rns_2026-05-12_9cc44c8f-ea41-4438-8b7a-b400a60452eb.pdf

Regulatory Filings

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C

SUVEN

Life Sciences

CSD/BSE&NSE/PR/2026-2027

May 12, 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: SUVEN

Dear Sir/Madam,

Sub: News Release

With reference to above subject, please find enclosed News Release of our company titled

"Suven Life Sciences Reaches 76% Enrollment milestone in Global Phase 3 Masupirdine (SUVN-502) Trial for Agitation in Alzheimer’s Dementia"

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: 2026.05.12

14:52:42 +05'30'

K. Sangeetha Laxmi

Company Secretary

Encl.: as above

Suven Life Sciences Limited

Registered Office: 8-2-334 | SDE Serene Chambers | 6th Floor Road No.5 | Avenue 7

Banjara Hills | Hyderabad – 500 034 | Telangana | India | CIN: L24110TG1989PLC009713

Tel: 91 40 2354 1142/ 1152 Email: [email protected] website: www.suven.com


SUVEN
Life Sciences

News Release

Suven Life Sciences Reaches 76% Enrollment milestone in Global Phase 3 Masupirdine (SUVN-502) Trial for Agitation in Alzheimer’s Dementia

Hyderabad, India (12 May 2026) - Suven Life Sciences, a clinical-stage biopharmaceutical company focused on discovering and developing innovative treatments for central nervous system (CNS) disorders, today announced the 76% enrolment milestone in its 375-patient, multi-center, randomized, double-blind, placebo-controlled Global Phase-3 study (NCT05397639, EudraCT Number 2021-003405-22) for the treatment of agitation in patients with dementia of the Alzheimer’s type (AAD) of its proprietary Phase 3 clinical candidate Masupirdine. The study is conducted across North America (USA) and Europe.

"This milestone reflects continued momentum in the program, completion of patient enrolment by End of calendar 2026 is certain if not earlier and last patient last visit will be in qtr. 1, 2027 enabling progression towards database lock and reporting of results potentially in Q2/ Q3-2027 calendar year. Patient enrolment activity has been accelerated through multiple additional resources, experienced investigators, medical experts, AI enabled patient identification and referral to the sites. Our goal is to advance the study towards completion with definitive timelines" said Mr. Venkat Jasti, Chairman and Managing Director of the Company.

"Agitation is a common neuropsychiatric symptom of dementia due to Alzheimer’s disease, and it is associated with increased caregiver burden and need for rapid institutionalization. Current treatment options are constrained by limited efficacy and concerns about tolerability and safety. Masupirdine a pure, potent, and selective 5-HT₆ receptor antagonist with all the potential to offer a differentiated, non-dopaminergic, non-sedative approach transforming Alzheimer’s agitation (AAD) management, delivering dual impact on behavioral stabilization and cognition" said Dr. Ramakrishna Nirogi, President and CSO of Suven Life Sciences.

The accrued data from the Phase 3 study suggest that the baseline characteristics of the enrolled patients are consistent with those observed in previous studies and are representative of an Alzheimer’s disease population with agitation. Suven and the CRO teams working towards the enrollment of Last Patient In (LPI) by September 2026 and Last Patient Last Visit (LPLV) by January 2027. Data readout is expected by April 2027.

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. Approximately 375 patients will be randomized 1:1:1 to receive Masupirdine 50 mg QD, 100 mg QD, or Placebo for 12 weeks’ treatment. 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.

Suven Life Sciences Limited
Registered Office: 8-2-334 | SDE Serene Chambers | 6th Floor Road No.5 | Avenue 7
Banjara Hills | Hyderabad – 500 034 | Telangana | India | CIN: L24110TG1989PLC009713
Tel: 91 40 2354 1142/ 1152 Email: [email protected] website: www.suven.com


SUVEN
Life Sciences

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); Ropanisant (SUVN-911) for MDD (Open-label Phase-2a study completed; Double blind randomized Placebo controlled Phase-2b study completed); 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 have 7 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.

Suven Life Sciences Limited
Registered Office: 8-2-334 | SDE Serene Chambers | 6th Floor Road No.5 | Avenue 7
Banjara Hills | Hyderabad – 500 034 | Telangana | India | CIN: L24110TG1989PLC009713
Tel: 91 40 2354 1142/ 1152 Email: [email protected] website: www.suven.com