In a dramatic intraday reversal, shares of pharmaceutical giant Wockhardt skyrocketed on Monday, December 01, climbing a staggering 19.3% to hit a high of ₹1,473. This sharp upswing followed a company announcement that has sent ripples of excitement through the Indian stock market and the pharma sector.
A Historic Milestone for Indian Pharma
The catalyst for this massive rally was a landmark regulatory achievement. Wockhardt informed the exchanges that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel antibiotic, named Zaynich. This acceptance is particularly significant because it marks a first in history. This is the first time an NDA for a New Chemical Entity (NCE) developed by an Indian pharmaceutical company has been filed and accepted by the US FDA. The application was originally submitted on September 30, 2025.
Commenting on this transformative moment, Wockhardt stated, "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."
Zaynich: A Weapon Against Drug-Resistant Superbugs
Zaynich is not just another antibiotic. It is a first-in-class combination drug designed to combat some of the most dangerous and hard-to-treat bacterial infections in the world. The drug combines Zidebactam, a β-lactam enhancer, with Cefepime, a fourth-generation cephalosporin.
Its primary target is multidrug-resistant (MDR) and extensively drug-resistant (XDR) pathogens, which pose a severe global health threat. These include deadly strains like:
- Pseudomonas Aeruginosa
- Acinetobacter Baumannii
- Carbapenem-resistant bacteria
Recognizing its critical potential, the US FDA has granted Zaynich a Fast Track designation, a status reserved for drugs that address urgent unmet medical needs. This pathway ensures the FDA will prioritize its review of the Zaynich NDA. The drug is the result of a comprehensive, science-driven development program initiated by Wockhardt back in 2011, involving rigorous non-clinical and clinical studies.
Wockhardt's Stock: A Rollercoaster Journey
The recent surge provides much-needed relief for Wockhardt investors. The stock had been under significant pressure since hitting a one-year high in July 2025, shedding about 22% of its value in the subsequent months. This decline followed an extraordinary bull run between April 2023 and July 2025, where the shares transformed into a multibagger, soaring from ₹154 to ₹1,714—an astronomical gain of approximately 1,000%.
For the year 2025, the stock's performance had been muted, with a gain of only about 3% until recently, weighed down by the post-July weakness. However, the long-term picture remains exceptionally strong, with the stock delivering a 513% return over the past three years. The FDA's acceptance has now reignited investor optimism about the company's future growth trajectory, pivoting from its recent exit from the US generics business to a focus on innovative, high-value drugs like Zaynich.
