The shares of Wockhardt Ltd. has zoomed in trade on Monday after becoming the first company to receive USFDA acceptance for Zaynich antibiotic.
The stock was trading largely flat for the majority of the day before the company announced that the USFDA had accepted its New Drug Application (NDA) for its novel antibiotic, Zaynich.
Shares of Wockhardt are currently trading with gains of more than 11.25%, thanks to a sudden uptick after the announcement. The scrip is trading at Rs 1,363, reaching an intraday high of Rs 1,384.
The acceptance from the USFDA marks a pivotal moment not just for Wockhardt but for Indian pharma, as it highlights the ability of Indian pharma companies to innovate.
In addition to granting acceptance, the FDA has also granted Zaynich a fast-track status - an expedited review process that is typically reserved for drugs that show promise in treating serious conditions and addressing unmet medical needs.
Zaynich is a combination drug that merges two components. During clinical trails, the drug has shown 97% efficacy against serious carbapenem-resistant infections, considered among the hardest to treat.
“The FDA's acceptance of the Zaynich NDA is a historic and proud moment for the organisation and for India. It reaffirms our commitment to developing advanced anti-infective solutions for the world and demonstrates what Indian science and innovation can achieve on the global stage," Wockhardt said on receiving the nod from USFDA.
This acceptance from the USFDA may open up significant market opportunities for Wockhardt in the United States, one of the biggest pharmaceutical markets in the world, with Wockhardt now positioning itself as an innovator.
While innovation has been a key theme for Wockhardt, it hasn't particularly wooed investors in the recent past, with the stock falling 2.74% on a year-to-date basis.
Wockhardt is currently trading at a relative strength index of 54, which suggests neutral market sentiment.
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