Wockhardt shares extend gains, surge for second straight session; here is why

Shares of the Mumbai-based drug maker, Wockhardt, extended gains to the second straight session on Tuesday, December 2, a day after posting its best day in over five years in the previous session. Wockhardt shares rose as much as 6.43% to hit an intraday high of ₹1,566.90 on the National Stock Exchange. On the BSE, Wockhardt rose as much as 6.53% to an intraday high of ₹1,566.95.

The company on Monday 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.

Wockhardt shares were witnessing higher than usual volumes as trading volume spiked by 3.3 times to 98.89 lakh shares as against an average trading volume of 29.52 lakh shares.

As many as 8.02 lakh shares changed hands on the BSE compared with an average of 69,000 shares traded daily in the past two weeks.

As of 10:01 am, Wockhardt shares traded 2.74% higher at ₹1,511.15, outperforming the NIFTY Smallcap 100 index which was down 0.2%.