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Zydus today announced positive topline results from its completed EVIDENCES-X™ Phase II(b), prospective, multicentre, randomized, double-blind, placebo controlled clinical trial evaluating the efficacy and safety of Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis.
The liver biopsy-driven EVIDENCES-X™ study enrolled 189 subjects who were randomized in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg or placebo over a treatment period of 52 weeks. The study successfully met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52 with the treatment difference of 26.5%. In addition to achieving the primary endpoint, the study demonstrated encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation and ballooning assessments. Further details would be presented in the upcoming Liver Congress.
The EVIDENCES-X™ trial was led by Prof. Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine, and Prof. Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University, as co-Principal Investigators.
Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) and MASH, continue to represent significant unmet medical needs globally. Experts estimate that approximately 25% of adults worldwide are affected by MASLD, while MASH affects an estimated 5% to 20% of the adult population. MASH is characterized by hepatic steatosis, inflammation, and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure, liver cancer, and death.
Zydus Lifesciences Ltd gained for a third straight session today. The stock is quoting at Rs 1171, up 1.83% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.13% on the day, quoting at 24176.5. The Sensex is at 77308.83, down 0.21%. Zydus Lifesciences Ltd has risen around 6.53% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has risen around 2.95% in last one month and is currently quoting at 26626.3, up 0.52% on the day. The volume in the stock stood at 20.24 lakh shares today, compared to the daily average of 15.31 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1180, up 1.98% on the day. Zydus Lifesciences Ltd is up 19.66% in last one year as compared to a 1.32% drop in NIFTY and a 22.73% drop in the Nifty Pharma index.
The PE of the stock is 31.42 based on TTM earnings ending June 26.
Zydus Lifesciences announced the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).
The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Zydus' Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor® Injection, 25,000 mg/50 mL (500 mg/mL). The USFDA has designated the ANDA for the product as a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first day of commercial marketing of the product.
The product will be manufactured at the group's USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.
The brand product had annual sales of approximately USD 11.6 mn in the United States. (IQVIA MAT June-2026).
Zydus Lifesciences Ltd is down for a fifth straight session today. The stock is quoting at Rs 1106.5, down 0.82% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is down around 0.46% on the day, quoting at 24043.1. The Sensex is at 76859.21, down 0.49%.Zydus Lifesciences Ltd has lost around 3.7% in last one month.Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has increased around 0.84% in last one month and is currently quoting at 26361.9, down 0.53% on the day. The volume in the stock stood at 9.53 lakh shares today, compared to the daily average of 14.79 lakh shares in last one month.
The benchmark August futures contract for the stock is quoting at Rs 1110.1, down 0.87% on the day. Zydus Lifesciences Ltd jumped 12.53% in last one year as compared to a 4.02% slide in NIFTY and a 19.36% spurt in the Nifty Pharma index.
The PE of the stock is 30.57 based on TTM earnings ending June 26.
CIE Automotive India Ltd, Zydus Lifesciences Ltd, Chennai Petroleum Corporation Ltd, Amara Raja Energy & Mobility Ltd are among the other stocks to see a surge in volumes on NSE today, 11 August 2026.
Gland Pharma Ltd clocked volume of 76.21 lakh shares by 14:14 IST on NSE, a 13.82 times surge over two-week average daily volume of 5.52 lakh shares. The stock gained 8.01% to Rs.2,881.00. Volumes stood at 7.21 lakh shares in the last session.
CIE Automotive India Ltd registered volume of 30.04 lakh shares by 14:14 IST on NSE, a 9.29 fold spurt over two-week average daily volume of 3.23 lakh shares. The stock rose 0.02% to Rs.409.60. Volumes stood at 2.36 lakh shares in the last session.
Zydus Lifesciences Ltd recorded volume of 57.93 lakh shares by 14:14 IST on NSE, a 6.23 times surge over two-week average daily volume of 9.30 lakh shares. The stock gained 4.59% to Rs.1,170.40. Volumes stood at 9.32 lakh shares in the last session.
Chennai Petroleum Corporation Ltd saw volume of 108.89 lakh shares by 14:14 IST on NSE, a 6.18 fold spurt over two-week average daily volume of 17.61 lakh shares. The stock increased 14.22% to Rs.1,416.50. Volumes stood at 7.83 lakh shares in the last session.
Amara Raja Energy & Mobility Ltd witnessed volume of 70.1 lakh shares by 14:14 IST on NSE, a 6.17 times surge over two-week average daily volume of 11.36 lakh shares. The stock increased 7.98% to Rs.969.35. Volumes stood at 15.67 lakh shares in the last session.
Zydus Lifesciences Ltd gained for a third straight session today. The stock is quoting at Rs 1159, up 3.57% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.51% on the day, quoting at 24458.4. The Sensex is at 78163.16, down 0.48%. Zydus Lifesciences Ltd has gained around 2.45% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has gained around 3.63% in last one month and is currently quoting at 26479.55, up 0.36% on the day. The volume in the stock stood at 17.56 lakh shares today, compared to the daily average of 10.25 lakh shares in last one month.
The benchmark August futures contract for the stock is quoting at Rs 1160, up 3.69% on the day. Zydus Lifesciences Ltd is up 21.28% in last one year as compared to a 0.12% slide in NIFTY and a 22.17% slide in the Nifty Pharma index.
The PE of the stock is 30.29 based on TTM earnings ending March 26.