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

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. ParticularsQuarter EndedDec. 2025Dec. 2024% Var. Sales888.00721.00 23 OPM %19.9317.75 - PBDT142.0076.00 87 PBT77.0021.00 267 NP59.0014.00 321 Powered by Capital Market - Live News

Wockhardt will hold a meeting of the Board of Directors of the Company on 10 February 2026.Powered by Capital Market - Live News

Wockhardt announced that its novel intravenous antibiotic Foviscu� (WCK 4282) has successfully met the primary endpoint in a Phase 3 clinical trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum �-lactamase (ESBL) producing pathogens. ESBL enzymes make many commonly used antibiotics ineffective and are a major cause of difficult-to-treat hospital infections. With this milestone, Foviscu� becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study, following Emrok�, Emrok O�, Miqnaf�, and Zaynich�, further strengthening Wockhardt`s leadership in antibiotic discovery space. In a randomized, double-blind Phase 3 study, Foviscu� was directly compared with meropenem, a �last-line� gold-standard carbapenem widely used for severe drug-resistant Gram-negative infections. At the Test-of Cure visit, Foviscu� achieved a high clinical cure rate of 93.23% versus 92.31% with meropenem, thereby meeting the primary endpoint and demonstrating therapeutic equivalence with a similarly well-tolerated safety profile. This is the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections compared with meropenem. ICMR data show a high burden of ESBLs and rising resistance to commonly used antibiotics such as piperacillin/tazobactam and cefoperazone/sulbactam, increasingly forcing clinicians to rely on carbapenems (meropenem) and thereby accelerating carbapenem resistance. By providing an effective alternative, Foviscu� has the potential to reduce carbapenem use and strengthen antibiotic stewardship to curb antimicrobial resistance. Currently, approximately 65 lakh treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India.Foviscu� underwent a combined Phase 2 and Phase 3 program which enrolled 323 hospitalized cUTI and AP patients (Phase 2: 60; Phase 3: 263). The most common causative pathogens were Escherichia coli, Klebsiella spp., Enterobacter spp., and Pseudomonas spp. More than half of the Enterobacterales isolates (51.4%) were ESBL-positive, and 33.8% of Gram negatives were resistant to cefepime, underscoring the urgent need for stronger first-line treatment options in India, where ESBL prevalence is high.Powered by Capital Market - Live News

Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on 5 January 2026. The EMA is the regulatory authority responsible for the scientific evaluation, of new medicines across the 27 European Union (EU) Member States and three European Economic Area (EEA) countries�Iceland, Liechtenstein, and Norway�covering a total of 30 countries. Earlier, the EMA had informed Wockhardt that WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is eligible for Accelerated Assessment. This pathway allows 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 FDA.Based on the comprehensive clinical and regulatory data included in the application, Wockhardt expects WCK 5222 approval for treatment of resistant Gram negative infections across all countries under the EMA`s jurisdiction. The priority review status granted to WCK 5222 underscores the global urgency to make effective treatment options available for patients suffering from life-threatening multi-drug resistant infections.Notably, WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation. Powered by Capital Market - Live News