The NDA, originally filed on September 30, 2025, marks the first time an Indian pharmaceutical company has had an NDA for a New Chemical Entity accepted by the US FDA—a historic moment for the company.
The company highlighted that the acceptance underscores one of the most rigorous scientific and regulatory validations in global drug development, involving comprehensive clinical data, advanced manufacturing standards, and strict compliance requirements.
Zaynich, which has been granted Fast Track designation, is now set for priority review by the US FDA. The antibiotic works on a novel β-lactam enhancer mechanism and has drawn international interest for its strong efficacy against highly resistant Gram-negative pathogens—bacteria linked to severe infections, long hospital stays, and high mortality. Its potential has already been demonstrated through compassionate-use cases in critically ill patients in both India and the United States.
Technical Snapshot: RSI (14-day): Wockhardt’s Relative Strength Index (RSI) stands at 63.8. Typically, an RSI below 30 indicates an oversold condition, suggesting a potential buying opportunity, while an RSI above 70 signals an overbought condition, implying the stock may be due for a pullback. At 63.8, the stock is approaching the higher side but is not yet overbought.
Bullish Moving Averages: The stock is trading above all 8 key Simple Moving Averages (SMAs), ranging from the short-term 5-day SMA to the long-term 200-day SMA. This alignment indicates strong bullish momentum, as the price consistently remains above its recent and longer-term averages.
Over the past three years, the stock has surged around 530% and is currently trading with a market capitalization of Rs 24,968 crore.
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