Zydus Lifesciences Limited has informed the Exchange regarding a press release dated August 29, 2025, titled "Zydus Therapeutics Reports Positive Topline Results from EPICS-III Phase 2(b)/3 Trial of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis".
ZYDUSLIFE · price
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Awaiting price reaction for this filing.
Zydus Lifesciences announced that its US subsidiary Zydus Therapeutics' EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC) has met its primary endpoint. The trial showed a statistically significant treatment difference of 48.5% favoring Saroglitazar 1mg over placebo in achieving a clinically meaningful biochemical response at 52 weeks, with a p-value of less than 0.001. The drug was generally well tolerated, with side effects balanced between the treatment and placebo groups across 149 patients. Saroglitazar is the first PPAR alpha/gamma agonist to deliver positive Phase 3 data in PBC, and the drug already holds both Orphan Drug Designation and Fast Track Designation from the US FDA. Zydus plans to file a US regulatory application in the first quarter of 2026.
This is a major positive milestone for Zydus's innovation pipeline, strengthening the case for US approval of a first-in-class treatment for a rare liver disease with limited options. The news is likely to be viewed favorably by the market, though actual revenue impact depends on successful regulatory approval and commercialization.