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ZYDUSLIFE · price
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Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, announced that the US FDA granted Priority Review to the New Drug Application for saroglitazar. The drug is proposed for treating Primary Biliary Cholangitis (PBC) either in combination with ursodeoxycholic acid (UDCA) for patients with inadequate response, or as monotherapy for those unable to tolerate UDCA. The FDA has assigned a PDUFA target action date of November 27, 2026. Priority Review is typically granted for drugs that could offer significant improvements in safety or effectiveness.
Priority Review status signals FDA's recognition of potential therapeutic value, which could accelerate the drug's path to market. A successful approval would expand Zydus's US product portfolio and create a new revenue stream in the PBC treatment space.