Wockhardt share price jumps over 19% after US FDA accepts new drug application for Zaynich

Wockhardt, the pharmaceutical and biotechnology major, saw its shares soar sharply in Monday's intraday session, December 01, surging 19.3% to hit the day's high of ₹1,473 apiece. The sharp reversal in the stock from recent weakness was triggered after the company announced regulatory approval for its antibiotic drug Zaynich for bacterial infections.

The company, in its regulatory filing today, informed that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.

The application was originally filed on September 30, 2025, and its acceptance marks a transformative moment—not only for Wockhardt, but also for the entire Indian pharmaceutical industry.

"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," the company said in its regulatory filing.

Zaynich is a combination of Zidebactam, a β-lactam enhancer, and Cefepime, a fourth-generation cephalosporin. It is designed to tackle MDR and extensively drug-resistance (XDR) pathogens including Pseudomonas Aeruginosa, Acinetobacter Baumannii, and Carbapenem-resistant strains.

The company said Zaynich has been granted Fast Track designation by the US FDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assigning priority to the Zaynich NDA review.

Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical, and regulatory pathway, the company said.

Commenting on the milestone, Wockhardt said, "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 share price trend

The pharma shares have remained under pressure since hitting a one-year high in July 2025 and have so far lost 22% of their value. This weakness comes after a sustained rally that the shares witnessed between April 2023 and July 2025, resulting in a multibagger run.

During this period, they grew from ₹154 to ₹1,714, leading to a massive surge of 1,000%. In terms of yearly performance, the shares have gained only marginally by 3% in 2025 so far, as the recent weakness weighed on their annual performance, though the long-term trend still looks impressive, with a 513% gain over the last three years.

Disclaimer: The views and recommendations made above are those of individual analysts or broking companies, and not of Mint. We advise investors to check with certified experts before making any investment decisions.