Wockhardt shares post best day in over 5 years, jump 19% after USFDA accepts its NDA for antibiotic Zaynich

Shares of the Mumbai-based drug maker, Wockhardt, rose as much as 19.36%, the most in over five years, to hit an intraday high of ₹1,472.40 on the BSE. On the National Stock Exchange, Wockhardt shares advanced as much as 19.32% to hit an intraday high of ₹1,473.70.

The stock staged its best single day move since November 20, 2020 on Monday, December 1, after it informed exchanges that the United States drug regulator - United States Food and Drug Administration (USFDA) - accepted its new drug application (NDA) for its antibiotic drug Zaynich, marking a transformative moment—not only for Wockhardt, but also for the entire Indian pharmaceutical industry.

US FDA accepted Wockhardt's the NDA for novel antibiotic Zaynich. This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA, Wockhardt said in an exchange filing.

"Submitting an NDA to the US FDA represents one of the most stringent scientific and regulatory thresholds in global drug development. It demands robust clinical evidence, world-class manufacturing capabilities, and rigorous compliance across multidisciplinary domains. Wockhardt’s achievement underscores the organization’s scientific depth, innovation strength, and global-standard development excellence," Wockhardt said in a press release.

Zaynic was granted Fast Track designation by the US FDA, recognizing its potential to address urgent and unmet medical needs.

"A novel β-lactam enhancer mechanism based Zaynich has garnered international attention for its potent activity against highly resistant Gram-negative pathogens—microbes responsible for prolonged hospitalizations and significant mortality worldwide. Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in both India and the United States," Wockhardt added.

“The FDA’s acceptance of the Zaynich NDA is 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,” Wockhardt said in a statement.

Following this development Wockhardt shares came in very high demand as trading volume in the counter spiked by 18 times to 65.6 lakh shares compared with an average trading volume of 3.7 lakh shares.

On the BSE, as many as 4.31 lakh shares changed hands compared with an average of 19,000 shares traded daily in the past two weeks.

As of 1;30 pm, Wockhardt shares traded 18% higher at ₹1,457, outperforming the NIFTY Smallcap 100 index which was up 0.3%.