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

The European Medicines Agency (EMA) has informed Wockhardt that WCK 5222 (combination of Zidebactam 1g + Cefepime 2g) is eligible for Accelerated Assessment, following a pre-submission meeting with the EMA review team.The Accelerated Assessment designation reflects EMA��s view that WCK 5222 has the potential to address an unmet medical need by providing an effective therapeutic option for the treatment of following serious and life-threatening infections, particularly those caused by multi-drug-resistant (MDR) and extremely drug resistant (XDR) Gram negative pathogens.Complicated urinary tract infections (cUTI), including pyelonephritis �h Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) �h Complicated intra-abdominal infections (cIAI) �h Treatment of patients with bacteraemia occurring in association with, or suspected to be associated with, cUTI/acute pyelonephritis, HAP/VAP, or cIAI �h Treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment optionsIf approved, the proposed breadth of indications would support the use of WCK 5222 across a wide range of serious infections and contribute to addressing the growing public health challenge of antimicrobial resistance. WCK 5222 represents the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation, reflecting the advancement of an India-initiated global antimicrobial innovation efforts.  Powered by Capital Market - Live News

Wockhardt today announced that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich. The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment�not only for Wockhardt, but also for the entire Indian pharmaceutical industry. This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA. Zaynich has been granted Fast Track designation by the US FDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review.A novel �-lactam enhancer mechanism based Zaynich has garnered international attention for its potent activity against highly resistant Gram-negative pathogens�microbes responsible for prolonged hospitalizations and significant mortality worldwide. Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in both India and the United States.Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical and regulatory pathway.Powered by Capital Market - Live News

Net profit of Wockhardt reported to Rs 78.00 crore in the quarter ended September 2025 as against net loss of Rs 22.00 crore during the previous quarter ended September 2024. Sales declined 3.34% to Rs 782.00 crore in the quarter ended September 2025 as against Rs 809.00 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales782.00809.00 -3 OPM %22.7613.60 - PBDT144.0046.00 213 PBT91.00-9.00 LP NP78.00-22.00 LP Powered by Capital Market - Live News