Wockhardt Shares Soar 4% on European Regulator Filing for Novel Antibiotic WCK 5222

• Wockhardt shares surged 4% after filing a market authorization plea with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222.
• WCK 5222, a fixed-dose combination of Zidebactam and Cefepime, is eligible for EMA's accelerated assessment due to unmet medical need.
• The New Drug Application (NDA) for WCK 5222 is also under fast-track review by the US Food and Drug Administration (USFDA).
• Wockhardt expects WCK 5222 to be approved for resistant Gram-negative infections across EMA's jurisdiction.
• This marks the first new chemical entity (NCE) discovered and developed in India to seek pan-European marketing authorization, with a potential European market of $400-500 million.

Why It Matters: Wockhardt's WCK 5222 filing with EMA boosts shares, signaling significant market potential for the India-developed antibiotic.