Mumbai, December 31, 2025 Wockhardt Limited (NSE: WOCKPHARMA, BSE: 532300) shares were trading higher on Wednesday after the company announced that the European Medicines Agency has granted Accelerated Assessment status to its novel antibiotic candidate WCK 5222.
At around 12:44 PM IST, Wockhardt shares were trading at ₹1,427, up ₹52.80 or 3.84 percent from the previous close, with the stock moving between an intraday high of ₹1,438.80 and a low of ₹1,373.00.
EMA Grants Accelerated Assessment to WCK 5222
Wockhardt informed exchanges that the European Medicines Agency has confirmed WCK 5222 as eligible for Accelerated Assessment following a pre-submission meeting with the EMA review team .WCK 5222 is a combination of Zidebactam 1g and Cefepime 2g and is being developed to address serious and life-threatening infections caused by multi-drug-resistant and extremely drug-resistant Gram-negative pathogens.
The proposed indications include complicated urinary tract infections, hospital-acquired pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections, and bacteraemia associated with these conditions. The therapy is also intended for adult patients with limited treatment options for aerobic Gram-negative infections.
Significance of Accelerated Assessment
During the scientific review process, the EMA highlighted the novel beta-lactam enhancer mechanism of action of WCK 5222 and its ability to overcome multiple resistance mechanisms in Gram-negative bacteria. Based on available non-clinical, clinical, and pharmacokinetic-pharmacodynamic data, the EMA concurred that the drug qualifies for accelerated assessment under Article 14(9) of Regulation (EC) No 726/2004.If approved, the broad set of indications would allow WCK 5222 to be used across a wide range of severe infections, addressing the growing global challenge of antimicrobial resistance.
Development and Regulatory Progress
WCK 5222 represents the first new chemical entity discovered and developed in India to be submitted for pan-European marketing authorisation. The drug, branded as Zaynich, has completed a global Phase III clinical trial. Its New Drug Application has been filed and accepted by the US Food and Drug Administration, and a marketing authorisation application has also been submitted to Indian regulatory authorities.More than 50 patients in India and the United States with highly resistant infections have already been treated under compassionate use programmes.
About the Company
Wockhardt Limited is a global pharmaceutical and biotechnology company focused on drug discovery, manufacturing, and commercialization, with a strong emphasis on antibiotics. The company has six antibiotics in its discovery portfolio, all of which have received Qualified Infectious Disease Product designation from the US FDA. Wockhardt has operations across India, Europe, the US, and several other international markets, with a majority of its revenue generated from global businesses.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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