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Wockhardt today announced the submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, ZAYNICH™). The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria including multidrug-resistant (MDR). In US and EU, more than 8 Million cUTI cases are reported every year, reflecting the global burden of Gram negative infections.
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation.
Amidst the escalating global crisis of antimicrobial resistance (AMR), Zidebactam-Cefepime represents a first-in-class â-lactam enhancer and â-lactam combination, introducing a novel mechanism of action to combat some of the most difficult-to-treat infections particularly those that remain unresponsive to approved antibiotics, including those that are recently approved. Clinical and non-clinical studies have demonstrated its potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens, including those harbouring NDM carbapenemases and PBP mutations. A Phase II study undertaken has demonstrated its efficacy against diverse carbapenem-resistant infections.
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial (ENHANCE 1), conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China. The program is supported by a robust clinical development package, including nine Phase I studies conducted in the U.S. and China, a Phase II study conducted in India and a multinational Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
Zidebactam-cefepime has been granted qualified infectious disease product (QIDP) and Fast Track Designation by US FDA.
Gram-negative infections have become increasingly difficult to treat due to wide spread resistance to multiple classes of antibiotics. Zaynich™ has the potential to treat a broad range of infections caused by MDR or XDR pathogens including Enterobacterales and Pseudomonas aeruginosa and A. baumannii.
The Phase 3 trial, involving about 500 patients, compared Miqnaf with moxifloxacin. The study reported non-inferior efficacy, with more than 90% of patients showing improvement within 3-4 days of treatment initiation.
Wockhardt said Miqnaf is designed as a once-daily, three-day oral regimen. The company noted that the drug aims to address rising antibiotic resistance, with the Indian Council of Medical Research estimating macrolide resistance at nearly 75% in 2023.
Wockhardt is a research based global pharmaceutical and biotech company. On a consolidated basis, Wockhardt reported net loss of Rs 90 crore in Q1 June 2025 as against net loss of Rs 14 crore in Q1 June 2024. Net sales declined 0.14% YoY to Rs 738 crore in Q1 June 2025.
Mangalore Refinery And Petrochemicals Ltd, Sammaan Capital Ltd, Bharat Forge Ltd, Petronet LNG Ltd are among the other stocks to see a surge in volumes on NSE today, 29 September 2025.
Wockhardt Ltd notched up volume of 67.62 lakh shares by 14:14 IST on NSE, a 14.76 fold spurt over two-week average daily volume of 4.58 lakh shares. The stock rose 15.09% to Rs.1,538.20. Volumes stood at 23.24 lakh shares in the last session.
Mangalore Refinery And Petrochemicals Ltd saw volume of 126.1 lakh shares by 14:14 IST on NSE, a 8.43 fold spurt over two-week average daily volume of 14.96 lakh shares. The stock increased 5.46% to Rs.134.35. Volumes stood at 18.44 lakh shares in the last session.
Sammaan Capital Ltd saw volume of 1170.26 lakh shares by 14:14 IST on NSE, a 6.25 fold spurt over two-week average daily volume of 187.29 lakh shares. The stock increased 11.67% to Rs.153.91. Volumes stood at 204.12 lakh shares in the last session.
Bharat Forge Ltd notched up volume of 47.71 lakh shares by 14:14 IST on NSE, a 4.98 fold spurt over two-week average daily volume of 9.58 lakh shares. The stock rose 3.64% to Rs.1,224.10. Volumes stood at 7.05 lakh shares in the last session.
Petronet LNG Ltd notched up volume of 80.94 lakh shares by 14:14 IST on NSE, a 4.65 fold spurt over two-week average daily volume of 17.40 lakh shares. The stock rose 4.68% to Rs.279.40. Volumes stood at 18.95 lakh shares in the last session.
Vodafone Idea Ltd, Wockhardt Ltd, Solara Active Pharma Sciences Ltd and Prudent Corporate Advisory Services Ltd are among the other losers in the BSE's 'A' group today, 26 September 2025.
PC Jeweller Ltd lost 8.62% to Rs 12.29 at 14:47 IST.The stock was the biggest loser in the BSE's 'A' group.On the BSE, 203.38 lakh shares were traded on the counter so far as against the average daily volumes of 85.89 lakh shares in the past one month.
Vodafone Idea Ltd tumbled 8.41% to Rs 7.95. The stock was the second biggest loser in 'A' group.On the BSE, 1268.84 lakh shares were traded on the counter so far as against the average daily volumes of 924.81 lakh shares in the past one month.
Wockhardt Ltd crashed 7.96% to Rs 1356.75. The stock was the third biggest loser in 'A' group.On the BSE, 70643 shares were traded on the counter so far as against the average daily volumes of 17994 shares in the past one month.
Solara Active Pharma Sciences Ltd pared 7.88% to Rs 620. The stock was the fourth biggest loser in 'A' group.On the BSE, 1.18 lakh shares were traded on the counter so far as against the average daily volumes of 36406 shares in the past one month.
Prudent Corporate Advisory Services Ltd slipped 7.56% to Rs 2575. The stock was the fifth biggest loser in 'A' group.On the BSE, 7517 shares were traded on the counter so far as against the average daily volumes of 1669 shares in the past one month.