Zydus Lifesciences Limited has published the offer opening advertisement for its buyback of up to 87,30,158 equity shares at ₹1,260 per share for an aggregate amount of ₹1,100 crore. The offer is being conducted on a proportionate basis through the tender offer route using the stock exchange mechanism. The record date for determining eligibility is May 29, 2026, and the letter of offer was dispatched to eligible shareholders on June 2, 2026.

The buyback represents 0.87% of the total paid-up equity share capital. The revised buyback price of ₹1,260 per share marks an increase from the originally proposed ₹1,150, while the maximum number of shares repurchased has been reduced to 87,30,158. The offer is scheduled to open on June 4, 2026, and close on June 10, 2026. The Buyback Size represents 5.16% and 3.84% of the aggregate of the total paid-up equity share capital and free reserves of the company as per the latest audited standalone and consolidated financial statements as at March 31, 2026, respectively.

Buyback Parameters

The updated details of the buyback offer are as follows:

Entitlement Ratios

The buyback entitlement ratios for eligible shareholders are detailed below:

Shareholding and Process

The pre-buyback shareholding pattern shows the promoter and promoter group holding 74.99% of the total equity shares. Other major categories include foreign portfolio investors at 6.86% and insurance companies at 6.12%. The company has appointed ICICI Securities Limited as the manager to the buyback and MUFG Intime India Private Limited as the registrar. The last date for receipt of completed tender forms and other specified documents by the registrar is on or before 5:00 PM on Wednesday, June 10, 2026.

Zydus Lifesciences has received a US FDA Priority Review designation for its New Drug Application (NDA) for Saroglitazar, intended to treat Primary Biliary Cholangitis (PBC). The US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. This regulatory milestone is supported by positive Phase 3 results from the EPICS-III trial, which demonstrated a statistically significant biochemical response in patients treated with Saroglitazar compared to placebo.

EPICS-III Trial Results

The EPICS-III trial was a randomized, double-blind, placebo-controlled study evaluating Saroglitazar in adult patients with PBC who had an inadequate response to or intolerance of ursodeoxycholic acid (UDCA). The study met its primary endpoint at Week 52, showing a clinically meaningful biochemical response. The following table summarizes the key efficacy findings:

Patients receiving Saroglitazar achieved a reduction in alkaline phosphatase (ALP) levels of 33.5%, compared to a 6.5% increase in the placebo group. The treatment difference in mean ALP levels was 40.1%. Among participants with baseline ALP ≤ 3 × ULN, biochemical response was 83.1% for Saroglitazar versus 14.7% for placebo.

Safety and Secondary Endpoints

Saroglitazar was generally well-tolerated in the trial. Serious adverse events were reported in 6.3% of patients in the Saroglitazar group versus 11.1% in the placebo group. No treatment-related deaths were reported. As a secondary endpoint, patients treated with Saroglitazar experienced a statistically significant reduction in pruritus at Week 24 compared to placebo, with a change from baseline in 5-D Itch Total score of -5.9 versus -2.7.

Regulatory Pathway and Launch Plans

The Priority Review designation directs US FDA attention and resources to applications for drugs that may provide significant improvements in the treatment of serious conditions. Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, plans to launch Saroglitazar in the United States in Q4 of FY 27, subject to approval. The data from the EPICS-III trial will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on May 30, 2026.