Zydus Therapeutics receives USFDA priority review to NDA for Saroglitazar

Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited, a global innovation-led health care company, today announced that the US Food and Drug Administration (US FDA) granted Priority Review to the New Drug Application (NDA) for saroglitazar. The proposed indication is for the treatment of 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1085.95 as compared to the previous close of Rs. 1078.95. The total number of shares traded during the day was 93822 in over 5949 trades.

The stock hit an intraday high of Rs. 1089.30 and intraday low of 1074.00. The net turnover during the day was Rs. 101797834.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals ZydusTherapeutics USFDA PriorityReview NDA Saroglitazar