Shares of Wockhardt Ltd. surged for a second consecutive session on December 2, jumping over 6% to ₹1,566.90, following the company's announcement that the US Food and Drug Administration (FDA) has formally accepted the New Drug Application (NDA) for its novel antibiotic, Zaynich.

The stock has skyrocketed nearly 27% in just two days, adding approximately ₹5,400 crore to its market capitalization, which now stands at ₹25,493 crore.

A Historic Milestone for Indian Pharma

In an exchange filing, Wockhardt stated that the acceptance of the NDA for Zaynich marks a "transformative moment" for both the company and the Indian pharmaceutical industry. The company emphasized that this is the first time an NDA for a New Chemical Entity (NCE) from an Indian company has been filed and accepted by the US FDA.

Zaynich is designed to treat complicated urinary tract infections (cUTIs) caused by multi-drug resistant gram-negative bacteria, a critical area of unmet medical need.

Fast-Track Review and Development Journey

The US FDA has granted Fast Track designation to Zaynich's NDA, prioritizing its review. Wockhardt highlighted that the antibiotic employs a novel β-lactam enhancer mechanism and has shown potent activity against highly resistant pathogens. Its life-saving potential has already been observed through compassionate use in critically ill patients in India and the United States.

The development program for Zaynich began in 2011. The company noted that it has successfully navigated a demanding non-clinical, clinical, and regulatory pathway to reach this stage.

Management Commentary

Wockhardt described the FDA's acceptance as a "historic and proud moment" for the organization and for India. "It reaffirms our commitment to developing advanced anti-infective solutions for the world and demonstrates what Indian science and innovation can achieve on the global stage," the company stated.