Wockardt shares gain 4% after filing market authorisation plea with European regulator for WCK 5222

Shares of Wockhardt Ltd. gained nearly 4% on Wednesday, January 7, after the company said it has filed a marketing authorisation application with the European Medicines Agency for its novel antibiotic, WCK 5222, two days ago.

Earlier, the EMA had informed Wockhardt that WCK 5222, a fixed-dose combination of Zidebactacm (1g) and Cefepime (2g), is eligible for accelerated assessment. The pathway permits for an abridged review timeline, reflecting the unmet medical need addressed by the product.

The New Drug Application (NDA) on WCK 5222 is already under fast-track review by the US Food and Drug Administration (USFDA), the company said.

Based on the comprehensive clinical and regulatory data included in the application, Wockhardt

is expecting WCK 5222 approval for the treatment of resistant Gram negative infections across all countries under the EMA's jurisdiction, the company said.

It added that WCK 5222 is the first new chemical entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation.

In an interaction with CNBC-TV18 on January 1 this year, Wockhardt's Habil Khorakiwala had said that the European approval for Zaynich is now expected by July and August this year and that its market size in the continent could be between $400 million to $500 million.

Khorakiwala also said that Zaynich's numbers will begin reflecting in the balance sheet by financial year 2028.

Shares of Wockhardt are trading 3.2% higher on Wednesday at ₹1,514. The stock is up 15% in the last one month.

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