Zydus Lifesciences shares fell 2.24% to ₹1,053.10 following the company's announcement of receiving a warning letter from the US FDA. According to Business Standard, the stock had previously hit a 52-week high of ₹1,115.5 per share on May 29, 2026, before the latest development. The warning letter was issued in response to a request for records pursuant to a section of the Federal Food, Drug, and Cosmetic Act, and does not pertain to any on-site inspection of the facility by the US FDA.
The warning letter was issued regarding technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. As reported by Business Standard, Zydus Lifesciences stated that the Baddi manufacturing facility was last subjected to an on-site inspection by the USFDA in August 2025. Subsequent to the conclusion of the inspection, the company received the establishment inspection report (EIR) in October 2025, with the final compliance status classified as voluntary action indicated (VAI). The company believes that the warning letter will not impact current operations and supplies from the Baddi site.
Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited, announced that the US FDA granted Priority Review to the New Drug Application (NDA) for saroglitazar. As reported by The Economic Times, the proposed indication is for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. Managing Director of Zydus Lifesciences, Sharvil Patel, stated that the acceptance of their NDA with priority review highlights the significant unmet need for patients with PBC and represents an important step in the path to making saroglitazar available in the US. The company plans to launch saroglitazar in the US in the fourth quarter of fiscal year 2027.
The NDA is supported by EPICS-III trial Phase 3 results that evaluated saroglitazar in adult patients with PBC who had an inadequate response to or intolerance of UDCA. According to The Economic Times, the trial results demonstrated significant biochemical response and data will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on Saturday. Saroglitazar met the primary endpoint of biochemical response, with 56.7% of patients treated with saroglitazar achieving biochemical response versus 9.8% of patients receiving placebo, a treatment difference of 48%. Additionally, saroglitazar demonstrated a treatment difference of 40.1% in mean alkaline phosphatase (ALP) levels, reducing ALP by 33.5% versus a 6.5% increase among patients receiving placebo. The company noted that saroglitazar was generally well-tolerated in the EPICS-III trial, with most adverse events being mild to moderate in nature.
Despite the regulatory concerns, Zydus Lifesciences reported strong financial results for Q4 FY26. According to Business Standard, the company's consolidated net profit jumped 8.68% to ₹1,272.5 crore on a 16.22% increase in revenue from operations to ₹7,587 crore compared to Q4 FY25. The company operates as an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
