Indian Pharma Breakthrough: Wockhardt’s Zaynich NDA Accepted by US FDA
Zaynich NDA acceptance boosts Wockhardt shares 6.5%. FDA fast-track status highlights drug’s potential for unmet medical needs.
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Wockhardt's shares rose in the early session on Tuesday while major indices were falling, which illustrates the indecisiveness of the market as far as the future repo rate cuts are concerned. The stock started at Rs 1,492.95 on the BSE, marking an increase from the previous day’s close of Rs 1,470.90.
The trading came alive and the volumes increased by more than 11 times the daily average. The stock reached an intraday high of Rs 1,566.95, indicating a rise of 6.53% from the closing price of the previous trading day. On the NSE, Wockhardt began the session at Rs 1,492 and touched Rs 1,566.90 at its peak. Just before noon, the share was valued at Rs 1,520.45, thus putting the company’s market worth at Rs 24,705.12 crore.
The stock's 52-week high and low are at Rs 1,109.60 and Rs 1,870 respectively. In the last two sessions, the market price of the stock has gone up 24.05% accompanied by a circuit upper of Rs 1,480.25 on Monday. Technical indicators reveal that Wockhardt is being traded above the 5-day, 20-day, 50-day, 100-day and 200-day moving averages.
The company located in Mumbai has disclosed that the FDA has accepted the NDA for Zaynich, which is the company's first antibiotic that will be positioned as a first-in-class. The NDA was submitted on 30 September 2025, and its acceptance is considered as an epoch-making moment not only for Wockhardt but also for the Indian pharmaceuticals industry.
The Indian pharmaceutical company is claiming that this is the first time an NCE from India has had its NDA accepted by the US regulator. "Filing an NDA with the US FDA is a hallmark of the utmost scientific and regulatory hurdles in the development of drugs globally," the company stated.
Besides, Zaynich has been acknowledged by the US FDA as a drug that is very fast in delivery, signifying its capability of addressing urgent medical needs that were previously and partly unmet.
Stock Performance Summary
BSE Open: Rs 1,492.95
BSE High: Rs 1,566.95
NSE Open: Rs 1,492
NSE High: Rs 1,566.90
Current Price: Rs 1,520.45
Market Cap: Rs 24,705.12 crore
52-Week Range: Rs 1,109.60 – Rs 1,870
