Wockhardt gets U.S. FDA nod for Zaynich antibiotic; shares soar 19% to record high

Shares of Wockhardt surged over 19% to hit a fresh record high on Monday after the pharmaceutical company secured approval from the U.S. Food and Drug Administration (FDA) for its novel antibiotic, Zaynich (cefepime and zidebactam).

Boosted by the development, Wockhardt shares rallied as much as 19.2% to touch a new all-time high of ₹2,420 on the BSE. The stock has more than doubled from its 52-week low of ₹1,086.80 hit on March 23, 2026.

Earlier in the day, the pharma stock opened 17% higher at ₹2,377.95 against the previous close of ₹2,030.70. At the time of reporting, Wockhardt shares were trading 9.7% higher at ₹2,228, with a market capitalisation of ₹36,202 crore.

The counter witnessed strong trading activity, with 3.57 lakh shares changing hands compared with two-week average volume of 1.67 lakh shares.

U.S. FDA approves Zaynich antibiotic drug

In an exchange filing on Sunday, the company said the FDA approved Zaynich for the treatment of adult patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. The approval follows years of research and development by Wockhardt and comes at a time when antimicrobial resistance is increasingly being recognised as a major global health threat.

According to the company, Zaynich is a first-in-class intravenous antibiotic that combines the fourth-generation cephalosporin cefepime with zidebactam. Unlike conventional beta-lactam combinations, the drug simultaneously targets multiple penicillin-binding proteins, enabling it to combat some of the most challenging multidrug-resistant Gram-negative bacteria.

The FDA approval was based on data from the Phase 3 ENHANCE-1 clinical trial, which evaluated the efficacy and safety of the drug against meropenem, a widely used antibiotic. The study demonstrated a combined clinical cure and microbiological response rate of 89% for Zaynich, significantly higher than the 68.4% recorded for meropenem. The trial enrolled 530 patients across 64 sites in the United States, Europe, Latin America, China, and India.

Wockhardt highlighted that more than 2.8 million antimicrobial-resistant infections occur annually in the United States, resulting in over 35,000 deaths. Complicated urinary tract infections alone account for more than 600,000 hospitalisations every year, creating a substantial burden on healthcare systems.

Calling the approval a major breakthrough, Wockhardt Chairman Habil Khorakiwala said the drug addresses one of the most urgent unmet medical needs globally. He also noted that Zaynich is the first new chemical entity to be fully developed and commercialised by an Indian pharmaceutical company to receive FDA approval.

"This approval is a significant realization of our mission to provide patients with novel antibiotics that help address one of the most urgent global health threats—antimicrobial resistance," he said.

Dennis Deruelle, Chief Medical Officer at Wockhardt, said the drug offers a much-needed treatment option for patients battling aggressive and drug-resistant infections. Infectious disease specialist Keith Kaye of Rutgers Robert Wood Johnson Medical School described the approval as an important step in expanding the arsenal of therapies available against multidrug-resistant pathogens.

The FDA approval follows another regulatory milestone for the company. Zaynich was approved by India's Drugs Controller General (DCGI) on May 27, 2026. Wockhardt has also filed a marketing authorisation application with the European Medicines Agency, seeking approval for commercialisation in Europe.

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