Zydus Lifesciences Limited has informed the Exchange regarding a press release dated May 28, 2026, titled "Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA".
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Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, announced that the US FDA has granted Priority Review to its New Drug Application for saroglitazar to treat Primary Biliary Cholangitis (PBC). The FDA has assigned a PDUFA target action date of November 27, 2026. The Phase 3 EPICS-III trial demonstrated strong efficacy with 56.7% of patients achieving biochemical response versus 9.8% on placebo. The drug also showed a 33.5% reduction in alkaline phosphatase levels compared to a 6.5% increase for placebo. If approved, Zydus plans to launch saroglitazar in the US in Q4 FY27. The drug already has Orphan Drug Designation and Fast Track Designation from the FDA.
This represents a significant regulatory milestone for Zydus, bringing the company closer to entering the US market with saroglitazar for PBC, a rare liver disease with limited treatment options. Positive trial results and Priority Review status increase the likelihood of approval and could positively impact the company's revenue outlook.