Wockhardt Share Price Jumps 19% as US FDA Accepts NDA for Antibiotic Zaynich.

Wockhardt's share price saw a sharp surge on Monday after a major regulatory milestone. The company announced that the US FDA has officially accepted its New Drug Application (NDA) for Zaynich, an antibiotic designed to tackle complicated urinary tract infections. The announcement immediately lifted market sentiment around the stock across both Wockhardt NSE and Wockhardt BSE.

Market Performance: Wockhardt Share Price Today

Wockhardt shares snapped a two-session losing streak and rallied more than 19% during the session.

Key levels recorded:

• Intraday High: ₹1,473.70
• Recent Trend:
  • 5-day performance: +14%
  • 1-month performance: +3%
  • 6-month performance: marginal decline

The spike reflects a strong market reaction to the regulatory progress around Wockhardt Zaynich.

Main News: US FDA Accepts NDA for Wockhardt Zaynich

The company confirmed through an exchange filing that the NDA for Zaynich—first submitted on September 30—has now been formally accepted by the US FDA.

This moment is being described by Wockhardt as a landmark for India’s pharmaceutical ecosystem, as it is the first time an Indian company’s New Chemical Entity (NCE) has been filed and accepted at this regulatory level.

Zaynich targets complicated urinary tract infections (cUTIs) caused by multidrug-resistant gram-negative bacteria, an area with significant unmet medical needs.

The FDA has also granted the drug Fast Track Designation, which recognizes its potential to address urgent global health challenges. As part of this pathway, the application will receive priority attention during review.

Company Details: Inside the Development of Zaynich

Wockhardt shared deeper insights into Zaynich’s scientific background and development journey.

• Zaynich is built on a novel β-lactam enhancer mechanism, gaining global attention for its activity against highly resistant pathogens.
• Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in India and the United States.
• Development began in 2011, navigating extensive non-clinical and clinical protocols before reaching this regulatory milestone.

The company views the NDA acceptance as a proud step forward for Indian innovation and an important contribution to advanced anti-infective therapies.

Summary

Shares of Wockhardt soared 19% after the US FDA accepted the NDA for Zaynich, a novel antibiotic targeting complicated urinary tract infections linked to multidrug-resistant gram-negative bacteria. With Fast Track Designation already in place, this move stands out as a historic achievement for the company and the Indian pharma sector.

Developed since 2011, Zaynich reflects Wockhardt’s consistent investment in advanced, science-backed anti-infective research.