Wockhardt shares rally 19% after US FDA accepts NDA for breakthrough antibiotic Zaynich

Shares of Wockhardt Ltd. are trading 19% higher on Monday, December 1, after the company announced that the US Food and Drug Administration has formally accepted its New Drug Application for Zaynich, a breakthrough first-in-class antibiotic.

The application, filed on September 30, marks a historic moment for the Indian pharmaceutical industry. This is the first time the US FDA has accepted an NDA for a New Chemical Entity developed by an Indian company.

Zaynich is Wockhardt's novel antibiotic candidate aimed at tackling resistant bacterial infections, an area where global innovation has been limited.

The company said this acceptance by the US regulator is a major step forward in the drug's approval process and reflects the scientific strength behind its development.

Wockhardt added that the NDA acceptance represents not just a milestone for the company, but a major breakthrough for India's pharma sector, which has long been known for generics yet has been working to scale up innovation in new drug discovery.

The company said it remains committed to advancing Zaynich through the regulatory process, with the goal of bringing a new antibacterial solution to global markets at a time of rising antimicrobial resistance.

Following the announcement, shares of Wockhardt Ltd. are trading with gains of 19% at

₹1,467.10

. Despite today's gain, the stock is down 5% so far in 2025.