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.

Zydus Lifesciences Limited disclosed the transmission of 10,000 equity shares from Late Jasodaben Babubhai Patel to Mr. Samar Babubhai Patel, a member of the Promoter Group. The transaction was executed off-market on May 22, 2026, and the company received the intimation regarding this change on May 25, 2026. The disclosure was submitted to the stock exchanges in compliance with Regulation 7(2) of the SEBI (Prohibition of Insider Trading) Regulations, 2015.

The transfer of shares was necessitated by the death of Late Jasodaben Babubhai Patel, who was also a member of the Promoter Group. Following the transmission, Mr. Samar Babubhai Patel now holds 10,000 equity shares, representing 0.00% of the company's shareholding. The details of the change in holding were formally communicated to BSE Limited and the National Stock Exchange of India Limited by Dhaval N. Soni, Company Secretary and Compliance Officer of Zydus Lifesciences Limited.

Shareholding Details

The disclosure outlines the specific details of the securities held prior to and post the transmission. The transaction did not involve any trading in derivatives, as indicated in the filing.

The filing confirms that no derivatives were traded by the promoter group member during this period. The company has ensured that all necessary procedural requirements were met in informing the exchanges about the change in shareholding.