The benchmark BSE Sensex was 0.1% lower at 85,640, while the broader NSE Nifty 50 dipped 0.1% to 26,177, as worries over foreign outflows offset optimism on better-than-expected economic growth data.
Meanwhile, Wockhardt Ltd share price jumped 19% on Monday, December 1, after the company said the US Food and Drug Administration had accepted its New Drug Application for Zaynich, a first-in-class antibiotic candidate.
The NDA, submitted on September 30, represents a major milestone for Indian pharma, as it is the first New Chemical Entity developed in India to be taken up for review by the US FDA.
On December 1, 2025, Wockhardt Limited reported a major development in its drug innovation pipeline, stating that the US Food and Drug Administration (US FDA) has formally accepted the company’s New Drug Application (NDA) for its first-in-class antibiotic, Zaynich.
Wockhardt described the announcement as a landmark moment for both the company and the Indian pharmaceutical sector. This marks the first instance in which an NDA for a New Chemical Entity (NCE) from an Indian drug maker has been filed and accepted by the US FDA. The company noted that NDA acceptance reflects the scientific and development capabilities required to meet global regulatory standards, including strong clinical evidence, high-quality manufacturing systems, and strict compliance processes.
Zaynich has been developed as a novel, first-in-class antibiotic built on a new β-lactam enhancer mechanism. It is designed to target highly resistant Gram-negative pathogens, which are associated with elevated mortality and extended hospital stays. According to the company, the drug has already shown life-saving benefits through compassionate use in critically ill patients in both India and the United States. Development work on Zaynich began in 2011, making it one of the most comprehensively studied antibiotic candidates globally in recent years.
Wockhardt initially submitted the NDA on September 30, 2025. The US FDA has granted Fast Track designation to Zaynich, given its potential to address urgent and unmet medical needs. Under this designation, the application is expected to receive priority during the review process.
Wockhardt continues to position itself as a global pharmaceutical and biotechnology company focusing on innovative anti-infective research and the development of next-generation treatments aimed at combating antimicrobial resistance.
Wockhardt Ltd share price jumped 19% on Monday, December 1, after the company said the US Food and Drug Administration had accepted its New Drug Application for Zaynich, a first-in-class antibiotic candidate. As of 1:56 pm, the stock price was trading at ₹1,460.50 per share, up by 18.26%.
The stock price has surged over 13% in one month, while over the last year it is up by 6.63%.
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