Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release - Wockhardt Files Marketing Authorisation Application for WCK 5222 with European Medicines Agency.
WOCKPHARMA · price
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Wockhardt has filed a Marketing Authorisation Application with the European Medicines Agency on 5 January 2026 for its novel antibiotic WCK 5222, a fixed-dose combination of Zidebactam (1g) and Cefepime (2g) designed to treat multi-drug resistant Gram-negative infections. The EMA has confirmed the drug is eligible for Accelerated Assessment, which means a shorter review timeline. The same product (NDA) is already under fast-track review with the US FDA, and an application has also been filed with Indian regulators. Notably, this is the first New Chemical Entity discovered and developed in India to be submitted for pan-European marketing authorisation. With around 77% of Wockhardt's global revenues coming from international markets, European access could be a meaningful commercial opportunity once approved.
A positive regulatory milestone that moves Wockhardt closer to commercialising its lead novel antibiotic across 30 European countries. While not yet an approval, the accelerated assessment pathway could shorten the wait and support long-term revenue growth if granted.