Wockhardt shares jump 20% as US FDA accepts firm's new drug application for antibiotic Zaynich

Wockhardt share price

The shares of Wockhardt sharply surged 20 percent on December 1 after the company announced that the US FDA has formally accepted the New Drug Application (NDA) for its antibiotic Zaynich.

The shares of the company hit the upper circuit at Rs 1,482 apiece on Monday, snapping a two-session losing streak. Zaynich targets complicated urinary tract infections (cUTIs) caused by multi-drug resistant (MDR) gram-negative bacteria.

US FDA accepts Wockhardt's NDA for antibiotic Zaynich:

Wockhardt in its exchange filing said that the NDA was first filed on September 30, and its acceptance marks a "transformative moment, not only for Wockhardt, but also for the entire Indian pharmaceutical industry". "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," it added.

The pharma company said that the United States Food and Drug Administration (US FDA) has granted fast track designation to Zaynich NDA, recognizing its potential to address urgent and unmet medical needs. "As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review," it added.

"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 hospitalizations and significant mortality worldwide. Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in both India and the United States," Wockhardt said.

The science-driven program to develop Zaynich was initiated by Wockhardt in 2011, and the pharma company said that it has successfully navigated a demanding non-clinical, clinical and regulatory pathway. "With Zaynich, Wockhardt continues to drive forward its mission of delivering path breaking anti-infective therapies that respond to some of the most serious threats in global healthcare," it added.

Speaking about the development, Wockhardt said, "The FDA's acceptance of the Zaynich NDA is a historic and proud moment for the organization 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 share price history:

Wockhardt shares have gained nearly 14 percent in the past five days, and around 3 percent in the past one month. The stock has fallen marginally in the past six months.

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