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Wockhardt Shares Soar After US FDA Accepts New Drug Application for “Zaynich”
The FDA acceptance marks a historic milestone: Zaynich is the first new chemical-entity (NCE) developed by an Indian pharmaceutical company whose NDA has been accepted by the US regulator. Wockhardt said in its exchange filing that the NDA was filed on September 30, 2025.
- By Newsdesk
- New Delhi
- Dec 01, 2025
Shares of Wockhardt shot up nearly 20% on December 1, surging to ₹1,482 per share, after the U.S. Food and Drug Administration (FDA) formally accepted the company’s New Drug Application (NDA) for its antibiotic candidate Zaynich. The uptick snapped a two-session losing streak for the stock.
The FDA acceptance marks a historic milestone: Zaynich is the first new chemical-entity (NCE) developed by an Indian pharmaceutical company whose NDA has been accepted by the US regulator. Wockhardt said in its exchange filing that the NDA was filed on September 30, 2025.
In addition to the NDA acceptance, Zaynich has also been granted “fast track” status by the FDA- a designation that prioritizes its review, reflecting the antibiotic’s potential to address urgent unmet medical needs.
Zaynich is designed to treat complicated urinary tract infections (cUTIs) caused by multi-drug resistant (MDR) gram-negative bacteria — a serious and growing global health concern. According to Wockhardt, the drug works through a novel β-lactam enhancer mechanism, showing potent activity against highly resistant pathogens responsible for prolonged hospital stays and high mortality.
The development of Zaynich traces back to 2011, making its progression to this regulatory milestone a result of more than a decade of non-clinical, clinical, and regulatory work. Wockhardt said the acceptance of Zaynich’s NDA shows what Indian scientific and pharmaceutical innovation can achieve on the global stage.