Suven Life Sciences has 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. The DSMB recommended that the trial continue as planned without modifications to the study design or conduct, following a comprehensive evaluation of unblinded safety data from approximately 50% of randomized participants who had completed 12 weeks of treatment. No safety concerns were identified that would warrant changes to the protocol or additional follow-up.

In parallel, a pre-specified unblinded interim analysis was performed to assess sample size adequacy. Based on this analysis, the DSMB recommended no increase in sample size, supporting the continuation of the trial as originally planned. Enrollment continues to progress strongly, with approximately 88% of the planned patient population enrolled as of June 4, 2026. The company expects to complete enrollment by September 2026, with the last patient last visit anticipated in January 2027. Database lock and top-line results are expected in Q2-2027. Given the continued acceleration in enrollment, the company believes there is a potential to further advance these timelines.

Study Details

The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study conducted across approximately 80 sites in North America 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. Key study parameters are outlined below:

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. A key secondary endpoint is the modified Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C) related to agitation.

Management Commentary

"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," said Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences. "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."

Suven Life Sciences received a rectification order from the Income Tax Department, Kondapur, Hyderabad, for assessment year 2020-21. The order, communicated via email on May 28, 2026, disallows the weighted deduction claimed under Section 35(2AB) of the Income Tax Act, 1961, concerning expenditure incurred on Research & Development activities. The disallowance was attributed to the absence of approval from the Department of Scientific and Industrial Research (DSIR) in Form No. 3CL in the order passed under section 143(3) of the Act.

The company stated that it had previously submitted a detailed reply addressing both legal aspects and the merits of the case to contest the notice. However, the Assessing Officer passed the rectification order under Section 154 of the Act without considering the company's contentions. Suven Life Sciences has indicated that it intends to prefer an appeal to the appellate authority against this order.

Regulatory Disclosure Details

The disclosure was made to the exchanges pursuant to Regulation 30 read with Schedule III of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The following table summarizes the key details of the regulatory action:

Suven Life Sciences affirmed that it does not foresee any material impact of this order on its financials, operations, or other activities. The company is proceeding with the appeal process to challenge the disallowance.