Wockhardt Soars 19% after US FDA Approves Novel Antibiotic Zaynich

Shares of Wockhardt hit an all-time high of ₹2,420 on the BSE on Monday, surging 19% in intra-day trade. By 11:13 AM, the stock was trading 11.42% higher at ₹2,262.65.

Around 2.7 million equity shares changed hands across the NSE and BSE in the first 11 minutes of trading. Over the past month, the stock has rallied 75%, compared to a 3% decline in the BSE Sensex during the same period.

The rally followed Wockhardt's announcement that it had received approval from the US Food and Drug Administration (FDA) for Zaynich (cefepime and zidebactam), a novel intravenous antibiotic. The drug is approved for treating complicated urinary tract infections (cUTI), including pyelonephritis, in adults.

The company noted that over 2.8 million antimicrobial-resistant infections occur annually in the United States, resulting in more than 35,000 deaths. Complicated UTIs account for over 600,000 hospitalisations in the US each year and represent the primary target market for Zaynich. The drug's estimated market opportunity in the US alone is $9 billion, according to media reports.

How the Drug Works

Zaynich operates through a "beta-lactam enhancer mechanism" that simultaneously blocks two sequential steps in a bacterial pathway, enabling it to act against superbugs resistant to existing antibiotic treatments. "The synergy generated is so powerful that it overcomes virtually all known resistance mechanisms," Huzefa Patel, Chief Mentor for Drug Discovery at Wockhardt, told the Economic Times. The company expects US market exclusivity for Zaynich to extend to approximately 2038, Patel added.

Wockhardt currently has six antibiotics at various stages of clinical development and commercialisation; three targeting Gram-Negative pathogens and three targeting Gram-Positive infections. All six have received Qualified Infectious Disease Product (QIDP) designation from the US FDA.

Notably, on May 21, ICRA upgraded the credit ratings on Wockhardt's long-term and short-term bank facilities, citing improved financial performance, a healthy market position in India and Europe, adequate liquidity, and a stronger capital structure.

Wockhardt reported revenue growth of 12.9% in FY2026, driven by expansion in its biosimilars business in emerging markets and continued growth in Europe and India.

Its operating profit margin improved to 19.2% in FY2026 from 13.1% in FY2025. The company attributed these gains to a greater focus on margin-accretive segments, cost rationalisation measures, and its exit from the loss-making US generics business.