Wockhardt Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

The recommendation clears the path for final approval by the Drugs Controller General of India.

The recommendation follows a comprehensive evaluation of the drug?s clinical dossier, including nine phase-1 studies, a phase-2 study in meropenem-resistant infections, and a global phase-3 trial in complicated urinary tract infections and acute pyelonephritis, along with data from compassionate-use cases.

In the phase-3 study, zidebactam/cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure, indicating strong efficacy against resistant pathogens.

Zaynich is based on a novel beta-lactam enhancer mechanism targeting MDR/XDR gram-negative bacteria, addressing a critical unmet need in anti-infective therapy.

The asset has been developed over 15 years and is supported by a large body of clinical and real-world evidence, including use in severe infections such as hospital-acquired pneumonia and bloodstream infections.

The company further said that regulatory filings for the product have already been submitted in the United States and European Union and are currently under advanced stages of review.

Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions.

The company's consolidated net profit surged to Rs 59 crore in the quarter ended December 2025 as against Rs 14 crore during the previous quarter ended December 2024. Sales rose 23.16% to Rs 888 crore in Q3 FY26 as compared with Q3 FY25.

The scrip fell 1.05% to currently trade at Rs 1176.60 on the BSE.

Powered by Capital Market - Live News

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), has granted a favourable recommendation for marketing permission of Wockhardt's novel antibiotic, Zaynich? (Zidebactam/Cefepime), for the treatment of Gram-negative infections. This positive opinion paves the way for final approval of Zaynich? by the Drugs Controller General of India (DCGI).

The recommendation follows a comprehensive review of the product dossier, including non-clinical data, nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis (cUTI/AP), and data from 85 compassionate-use cases.

Developed over 15 years by a team of 150+ scientists across 10 disciplines, Zaynich? features a novel ?-lactam enhancer-based mechanism, enabling potentially unprecedented coverage of MDR/XDR Gram-negative pathogens prevalent in India. It is among the most comprehensively evaluated antibiotics globally in recent years, with over 100 national and international publications and presentations, the majority from independent experts.

The Zaynich? clinical program includes nine Phase 1 studies in the United States and China (nearly 300 subjects), followed by a global Phase 3 study in 530 patients across 64 sites in the United States, Europe, Latin America, China, and India, and a Phase 2 study in meropenem-resistant infections.

In the Phase 3 study, Zidebactam/Cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure, underscoring the impact of its novel mechanism of action. Earlier, it showed over 97% clinical efficacy in a real-world study of meropenem-resistant infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI, conducted across 15 leading tertiary care hospitals in India.

Zaynich? also demonstrated strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use in India, US, Malaysia and France where no safe and efficacious alternatives were available, highlighting the global unmet medical need in the treatment of resistant Gram negative infections, and the potential of Zaynich? to address it.

The Clinical and Laboratory Standards Institute (CLSI) has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L, indicating its potential to comprehensively cover clinically important XDR Gram-negative pathogens in critically ill patients.

A New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime have already been submitted and are currently in the advanced stages of review.

Powered by Capital Market - Live News

Wockhardt Ltd dropped for a fifth straight session today. The stock is quoting at Rs 1196.2, down 0.02% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is up around 0.62% on the day, quoting at 23554.7. The Sensex is at 75980.71, up 0.63%.Wockhardt Ltd has lost around 16.55% in last one month.Meanwhile, Nifty Pharma index of which Wockhardt Ltd is a constituent, has increased around 0.51% in last one month and is currently quoting at 22547.2, up 0.49% on the day. The volume in the stock stood at 2.31 lakh shares today, compared to the daily average of 3.99 lakh shares in last one month.

The PE of the stock is 96.91 based on TTM earnings ending December 25.

Powered by Capital Market - Live News

Net profit of Wockhardt rose 321.43% to Rs 59.00 crore in the quarter ended December 2025 as against Rs 14.00 crore during the previous quarter ended December 2024. Sales rose 23.16% to Rs 888.00 crore in the quarter ended December 2025 as against Rs 721.00 crore during the previous quarter ended December 2024.

Powered by Capital Market - Live News