Why Are Wockhardt Shares Rising Today? BSE 500 Pharma Stock Jumps 20% After USFDA’s BIG Update

Wockhardt Share Price Today: Shares of Wockhardt Limited jumped nearly 20% on Monday, after the Indian drugmaker received the United States Food and Drug Administration (US FDA) gave a cleanchit to its new drug.

Wockhardt shares were trading 18.31% higher at Rs 1459.4 per share on BSE with a market capitalisation of Rs 23,713.14 crore at 1:30 pm. The stock had jumped nearly 19.5% to touch an intraday high mark of Rs 1472.40 per share. Whereas, the stock dipped to its intraday low mark of Rs 1226.15 per share today.

Wockhardt Drug Receives USFDA Approval

The USFDA accepted the New Drug Application (NDA) for Wockhardt's antibiotic Zaynich drug. With this, Wockhardt became the first pharma company to receive USFDA approval for Zaynich antibiotic.

"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. 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," noted the company in its BSE-filing.

The antibiotic has also been granted Fast Track designation by the US FDA. The label recognises that the drug has the potential to address urgent and unmet medical needs.

"As part of this pathway, the FDA has committed to assigning priority to Zaynich NDA review. 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 hospitalisations and significant mortality worldwide," the BSE filing added.

What is Zaynich?

Zaynich is an antibiotic drug that merges two components in its combination formula. During the clinical trials, the drug has shown 97% efficacy against serious carbapenem-resistant infections. These infections are treated as the hardest to treat.

Zaynich has received approval of sales in multiple countries over the past few months. The company claims that the drug has become one of the "most extensively studied antibiotics globally". It reflected a comprehensive, science-driven development program initiated by Wockhardt in 2011.

Disclaimer: The views and recommendations expressed are solely those of the individual analysts or entities and do not reflect the views of Goodreturns.in or Greynium Information Technologies Private Limited (together referred as "we"). We do not guarantee, endorse or take responsibility for the accuracy, completeness or reliability of any content, nor do we provide any investment advice or solicit the purchase or sale of securities. All information is provided for informational and educational purposes only and should be independently verified from licensed financial advisors before making any investment decisions.