Mon Dec 01 14:40:00 UTC 2025: News Article:

Wockhardt Shares Soar as US FDA Accepts New Drug Application for Novel Antibiotic Zaynich

Mumbai, India – December 1, 2025 – Shares of Wockhardt Ltd. (BSE: [Insert BSE Code], NSE: [Insert NSE Code]) surged 20% today after the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Zaynich, a first-in-class antibiotic targeting highly resistant Gram-negative bacteria. The acceptance of the NDA marks a significant milestone for the Indian pharmaceutical company and the Indian pharmaceutical industry as a whole, as it is the first time an Indian company’s New Chemical Entity (NCE) NDA has been accepted by the US FDA.

Zaynich, which has been granted Fast Track designation by the FDA, addresses a critical unmet need in combating antibiotic-resistant infections. This designation allows for an accelerated review process, potentially bringing the life-saving drug to market sooner.

The antibiotic boasts a novel β-lactam enhancer mechanism that has demonstrated significant efficacy in treating infections caused by resistant Gram-negative bacteria, pathogens often associated with prolonged hospital stays and high mortality rates. According to the company, Zaynich has already shown promise in compassionate use programs, saving lives of critically ill patients in both India and the United States.

“The FDA’s acceptance of Zaynich’s NDA reinforces the company’s commitment to delivering advanced anti-infective solutions worldwide. This milestone highlights the potential of Indian science and innovation to make a global impact in the pharmaceutical sector” Wockhardt said in a statement.

Wockhardt’s success with Zaynich comes after a decade of dedicated research and development, including extensive non-clinical and clinical studies. The development demonstrates the company’s commitment to innovation and its ability to successfully navigate complex regulatory pathways on a global scale.

While Wockhardt reported a slight dip in sales year-over-year in Q2FY26 (Rs. 782 crore vs. Rs. 809 crore), the company saw a significant improvement in profitability, with EBITDA surging 62% to Rs. 178 crore and a net profit of Rs. 82 crore, a notable turnaround from a loss of Rs. 16 crore in the same period last year.

Investors responded positively to the news, sending Wockhardt shares to their upper circuit limit of Rs. 1,480.25.

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