Wockhardt shares are likely to remain in focus today, June 1, after the pharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepime and zidebactam), its novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis.
The latest regulatory milestone comes just days after the company secured approval in India. On May 28, Wockhardt announced that the Central Drugs Standard Control Organisation (CDSCO) had granted approval for the import and marketing of Zaynich® (Zidebactam/Cefepime) in India. The drug has been approved for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, as well as infections accompanied by Gram-negative bacteremia.
Investor sentiment had already turned positive following the India approval, with Wockhardt shares surging more than 15% on Friday as the market reacted to the company’s breakthrough antibiotic receiving domestic regulatory clearance.
According to the company, the U.S. FDA approval covers the treatment of adults suffering from complicated urinary tract infections caused by susceptible Gram-negative pathogens. ZAYNICH™ had earlier received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
The approval is supported by results from the Phase 3 ENHANCE-1 clinical trial, a randomized, double-blind, multicentre study evaluating the efficacy and safety of the antibiotic. In the study, ZAYNICH™ achieved a composite clinical cure and microbiological response rate of 89% compared with 68.4% for meropenem, demonstrating statistically superior efficacy. The trial enrolled 530 patients across the United States, Europe, Latin America, China and India.
Commenting on the approval, Wockhardt said the development marks a significant milestone in its efforts to address antimicrobial resistance, one of the most pressing global healthcare challenges. The company noted that ZAYNICH™ is designed to target multidrug-resistant Gram-negative bacteria, an area where treatment options remain limited.
The company has also submitted a Marketing Authorization Application (MAA) for the antibiotic to the European Medicines Agency, as it looks to expand the product’s global reach.
With regulatory approvals now secured in both India and the United States within a span of days, investors will closely monitor the stock when trading resumes on Monday.
Disclaimer: This article is for informational purposes only and should not be construed as investment advice. Investors should consult qualified financial advisors before making any investment decisions.