20% Upper Circuit: Pharma stock hits 20% upper circuit; Here are the 3 main reasons

Synopsis: Wockhardt Ltd surged 20% after the US FDA accepted its NDA for Zaynich, a first-in-class antibiotic with Fast Track designation, marking a historic milestone for the company and Indian pharmaceutical innovation.

The shares of  this global pharmaceutical and biotechnology organization engaged in manufacturing finished dosage formulations, injectables, biopharmaceuticals is now in the spotlight after the US FDA accepted its new drug application for the breakthrough antibiotic Zaynich.

With market capitalization of Rs. 24,053 cr, the shares of Wockhardt Ltd are currently trading at Rs. 1,480.25 per share, locked at 20% upper circuit in today’s market session,from its previous close of Rs. 1,233.55 per share.

The reason behind 20% upper circuit is:

On December 1, 2025, Wockhardt Limited, a leading Indian pharmaceutical company announced that the United States Food and Drug Administration (US FDA) has accepted its New Drug Application (NDA) for Zaynich, a first-in-class antibiotic. 

This is a landmark achievement as it represents the first time an Indian pharmaceutical company’s New Chemical Entity (NCE) NDA has been filed and formally accepted by the US FDA. The acceptance of this NDA signifies a significant milestone not only for Wockhardt but also for the Indian pharmaceutical industry as a whole, highlighting India’s growing influence in global drug development.

Submitting an NDA to the US FDA is considered one of the most rigorous regulatory and scientific achievements in the pharmaceutical sector. It requires extensive clinical evidence, high-quality manufacturing standards, and compliance with strict regulatory requirements across multiple domains. Wockhardt’s success in achieving NDA acceptance underscores its scientific expertise, innovation capabilities, and adherence to global standards in drug development.

Zaynich has received the US FDA’s Fast Track designation, which acknowledges its potential to address urgent and unmet medical needs. This designation ensures that the FDA will prioritize the review of Zaynich’s NDA, potentially accelerating the drug’s path to market. 

Fast Track status is granted to drugs that treat serious conditions and demonstrate the potential to fulfill unmet healthcare needs, reflecting the global importance of Zaynich in combating resistant infections.

Zaynich is based on a novel β-lactam enhancer mechanism, which has shown significant efficacy against highly resistant Gram-negative bacteria. These pathogens are associated with prolonged hospital stays and high mortality rates worldwide. The drug has already demonstrated life-saving potential through compassionate use programs in critically ill patients in both India and the United States. Its unique mechanism and robust clinical performance have attracted international attention.

The development of Zaynich has been a decade-long effort, beginning in 2011. Wockhardt has conducted extensive non-clinical and clinical studies, reflecting a comprehensive, science-driven development strategy. This effort demonstrates the company’s commitment to innovation and its ability to successfully navigate complex regulatory pathways on a global scale.

Wockhardt expressed pride in this historic achievement, emphasizing that the FDA’s acceptance of Zaynich’s NDA reinforces the company’s commitment to delivering advanced anti-infective solutions worldwide. The milestone highlights the potential of Indian science and innovation to make a global impact in the pharmaceutical sector.

Wockhardt Ltd is a global pharmaceutical and biotechnology company specializing in the development of innovative anti-infective and therapeutic solutions. With a legacy of scientific excellence, the company focuses on addressing critical healthcare challenges, including antimicrobial resistance, through research-driven, next-generation therapies.

On a year-over-year basis, the company’s sales slightly declined by 3% to Rs. 782 crore in Q2FY26, down from Rs. 809 crore in Q2FY25. EBITDA surged by 62% to Rs. 178 crore compared to Rs. 110 crore a year ago. Net profit showed a remarkable improvement from a loss of Rs. 16 cr to a profit of Rs. 82 cr. Earnings per share (EPS) stands at Rs. 4.80 from a loss of Rs. 1.43 in the previous year.

Written by Manideep Appana

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