Wockhardt

The company said the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its first-in-class antibiotic 'Zaynich'

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Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. 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), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows

Thus far in the calendar year 2025, the BSE smallcap index has underperformed the market by falling 5%, as against 3% decline in midcap index and 3% rise in the BSE Sensex.

Shukra Pharmaceuticals on Wednesday said it has entered into a strategic non-exclusive Pan-India distribution arrangement with Wockhardt Ltd. The authorization is effective from September 9, 2025 and is valid until March 2026, an exchange filing said. The products include advanced anti-infective formulations and antibiotics developed to combat critical infections. The mandate includes distribution and management of products across all ESIC/ESIS hospitals and Defence/AFMSD/DGAFMS units throughout India, the filing said. "This collaboration further strengthens Shukra Pharmaceuticals presence in institutional and government healthcare networks across India, enhancing revenue visibility and operational footprint," the company said. Shukra Pharmaceuticals Limited is engaged in manufacturing and marketing pharmaceutical products as well as laboratory testing.

Wockhardt shares rose 2 per cent after it decided to exit the US generic pharmaceutical segment after incurring consistent losses

Wockhardt exits the US generics market after years of losses, shifting focus to new antibiotic drug discovery and biologicals, including insulin, to create long-term value.

The decision follows years of financial losses in the US generics business, including loss of nearly $8 million in FY 2025, Wockhardt said in a BSE filing

Shares of Wockhardt hit an all-time high of ₹1,809.95, as they rallied 17% on the BSE in Wednesday's intra-day trade surpassed its previous high of ₹1,678.60 touched on February 6, 2025.

Company to launch Zaynich in India this fiscal; sees $7 bn market in US and EU and ₹17,000 crore in India; USFDA, EU filings underway for FY26

Drug firm Wockhardt on Thursday reported a consolidated net loss of Rs 45 crore in the fourth quarter ended March 31, 2025. The drug maker had reported a net loss of Rs 177 crore in the January-March quarter of FY24. Revenue from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago period, Wockhardt said in a regulatory filing. For FY25, the company said its net loss stood at Rs 57 crore as compared to Rs 472 crore in the year-ago period. Revenue increased to Rs 3,012 crore as compared to Rs 2,798 crore in 2023-24 fiscal. Shares of the company closed at Rs 1,347.75 apiece, 0.63 per cent higher from previous close, on the BSE.

Wockhardt is planning to exit the US generics business, while American consumers are expected to bear the impact of tariffs

Wockhardt now intends to file a new drug application (NDA) with the USFDA and seek marketing authorisation application with European Medicines Agency (EMA)

Shares of Wockhardt were in high demand on Monday after the company said that its drug Zaynich has achieved over 97 per cent clinical efficacy in treating critically ill patients

The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has approved Miqnaf (nafithromycin) as a new treatment for the Community-Acquired Bacterial Pneumonia (CABP) in Adults

Wockhardt stock gained 10% to touch Rs 1,536.40; it has outperformed the market by zooming 262% thus far in calendar year 2024, as compared to the 13% rise in the BSE Sensex

Wockhardt's nafithromycin is India's first FDA-approved antimicrobial that is seen as an alternative to existing antibiotics like azithromycin, which is facing increasing resistance in humans

Drug firm Wockhardt on Wednesday reported a consolidated net loss of Rs 16 crore for the second quarter ended September 30, 2024. The company has reported a net loss of Rs 73 crore in July-September quarter of last fiscal. Revenue from operations stood at Rs 809 crore for the second quarter as compared with Rs 753 crore in the year-ago period, the Mumbai-based drug maker said in a regulatory filing. Shares of the company were trading 0.63 per cent up at Rs 1,189 apiece on BSE.

Wockhardt shares surged 5% to Rs 1,212.55, its highest level since February 2016 and has zoomed 157% thus far in the calendar year 2024.

Wockhardt is also developing additional insulin analogs and GLP-1 agonists to provide advanced diabetes care solutions