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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 â-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.
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.
Wockhardt Ltd is up for a third straight session today. The stock is quoting at Rs 1513.7, up 3.27% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.37% on the day, quoting at 26081.2. The Sensex is at 84749.13, down 0.37%. Wockhardt Ltd has gained around 15.08% in last one month.
Meanwhile, Nifty Pharma index of which Wockhardt Ltd is a constituent, has gained around 2.29% in last one month and is currently quoting at 23126.85, up 0.13% on the day. The volume in the stock stood at 6.09 lakh shares today, compared to the daily average of 9.18 lakh shares in last one month.
The PE of the stock is 168.77 based on TTM earnings ending September 25.
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.
If 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.
Wockhardt Ltd is up for a fifth straight session today. The stock is quoting at Rs 1436, up 1.76% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.6% on the day, quoting at 26121.85. The Sensex is at 85355.3, up 0.5%. Wockhardt Ltd has gained around 11.09% in last one month.
Meanwhile, Nifty Pharma index of which Wockhardt Ltd is a constituent, has gained around 1.81% in last one month and is currently quoting at 22751.25, up 0.65% on the day. The volume in the stock stood at 3.94 lakh shares today, compared to the daily average of 25.21 lakh shares in last one month.
The PE of the stock is 162.51 based on TTM earnings ending September 25.
Wockhardt Ltd is up for a third straight session in a row. The stock is quoting at Rs 1373, up 1.04% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.27% on the day, quoting at 25889.45. The Sensex is at 84718.27, up 0.19%. Wockhardt Ltd has risen around 3.19% in last one month.
Meanwhile, Nifty Pharma index of which Wockhardt Ltd is a constituent, has risen around 0.97% in last one month and is currently quoting at 22612.15, down 0.46% on the day. The volume in the stock stood at 2.8 lakh shares today, compared to the daily average of 22.15 lakh shares in last one month.
The PE of the stock is 156.56 based on TTM earnings ending September 25.
Kaynes Technology India Ltd, Wockhardt Ltd, Biocon Ltd and Ola Electric Mobility Ltd are among the other losers in the BSE's 'A' group today, 04 December 2025.
Hitachi Energy India Ltd lost 7.66% to Rs 20163.45 at 14:46 IST.The stock was the biggest loser in the BSE's 'A' group.On the BSE, 8192 shares were traded on the counter so far as against the average daily volumes of 5442 shares in the past one month.
Kaynes Technology India Ltd tumbled 6.15% to Rs 4979.95. The stock was the second biggest loser in 'A' group.On the BSE, 1.06 lakh shares were traded on the counter so far as against the average daily volumes of 76350 shares in the past one month.
Wockhardt Ltd crashed 5.81% to Rs 1333. The stock was the third biggest loser in 'A' group.On the BSE, 1.02 lakh shares were traded on the counter so far as against the average daily volumes of 1.19 lakh shares in the past one month.
Biocon Ltd corrected 5.58% to Rs 387.25. The stock was the fourth biggest loser in 'A' group.On the BSE, 4.27 lakh shares were traded on the counter so far as against the average daily volumes of 2.02 lakh shares in the past one month.
Ola Electric Mobility Ltd plummeted 5.00% to Rs 36.12. The stock was the fifth biggest loser in 'A' group.On the BSE, 51.74 lakh shares were traded on the counter so far as against the average daily volumes of 21.05 lakh shares in the past one month.
Wockhardt Ltd, KNR Constructions Ltd, Sun Pharma Advanced Research Company Ltd and Punjab National Bank are among the other losers in the BSE's 'A' group today, 03 December 2025.
Indian Bank crashed 5.81% to Rs 809.5 at 14:46 IST.The stock was the biggest loser in the BSE's 'A' group.On the BSE, 2.72 lakh shares were traded on the counter so far as against the average daily volumes of 39890 shares in the past one month.
Wockhardt Ltd tumbled 5.80% to Rs 1408.1. The stock was the second biggest loser in 'A' group.On the BSE, 1.69 lakh shares were traded on the counter so far as against the average daily volumes of 1.12 lakh shares in the past one month.
KNR Constructions Ltd lost 5.23% to Rs 150.55. The stock was the third biggest loser in 'A' group.On the BSE, 2.08 lakh shares were traded on the counter so far as against the average daily volumes of 2.05 lakh shares in the past one month.
Sun Pharma Advanced Research Company Ltd shed 4.90% to Rs 153.2. The stock was the fourth biggest loser in 'A' group.On the BSE, 134.71 lakh shares were traded on the counter so far as against the average daily volumes of 1.77 lakh shares in the past one month.
Punjab National Bank slipped 4.82% to Rs 119.45. The stock was the fifth biggest loser in 'A' group.On the BSE, 17.05 lakh shares were traded on the counter so far as against the average daily volumes of 8.19 lakh shares in the past one month.
The approval marks a landmark moment as it is the first time an Indian pharmaceutical company has had an NDA for a completely new chemical entity accepted by the US regulator. Zaynich, built on a novel β-lactam enhancer mechanism, has also received Fast Track status for its potential to address urgent medical needs. With over a decade of research behind it, the drug has demonstrated strong efficacy against highly resistant Gram-negative pathogens and has already helped critically ill patients in India and the US through compassionate use. The acceptance reflects confidence in Wockhardt's scientific depth and its global-standard development program.
Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions. The company posted a consolidated net profit of Rs 78 crore in Q2 FY26 compared with a net loss of Rs 22 crore a year earlier, while net sales declined 3.34% YoY to Rs 782 crore.
JM Financial Ltd, TVS Holdings Ltd, Tamilnad Mercantile Bank Ltd and Sharda Motor Industries Ltd are among the other gainers in the BSE's 'A' group today, 01 December 2025.
Wockhardt Ltd spiked 9.27% to Rs 1347.85 at 11:46 IST. The stock was the biggest gainer in the BSE's 'A' group. On the BSE, 40468 shares were traded on the counter so far as against the average daily volumes of 31541 shares in the past one month.
JM Financial Ltd surged 8.02% to Rs 157. The stock was the second biggest gainer in 'A' group. On the BSE, 23.23 lakh shares were traded on the counter so far as against the average daily volumes of 2.13 lakh shares in the past one month.
TVS Holdings Ltd soared 6.07% to Rs 15247.1. The stock was the third biggest gainer in 'A' group. On the BSE, 588 shares were traded on the counter so far as against the average daily volumes of 327 shares in the past one month.
Tamilnad Mercantile Bank Ltd advanced 5.72% to Rs 536.25. The stock was the fourth biggest gainer in 'A' group. On the BSE, 1.42 lakh shares were traded on the counter so far as against the average daily volumes of 11655 shares in the past one month.
Sharda Motor Industries Ltd exploded 5.63% to Rs 982.95. The stock was the fifth biggest gainer in 'A' group. On the BSE, 7193 shares were traded on the counter so far as against the average daily volumes of 11396 shares in the past one month.