Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release - "Wockhardt Receives U.S. FDA Approval for ZAYNICH (cefepime and zidebactam), a Novel Intravenous Antibiotic ....
WOCKPHARMA · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Wockhardt has received U.S. FDA approval for ZAYNICH, a novel intravenous antibiotic combining cefepime and zidebactam for treating complicated urinary tract infections including pyelonephritis in adults. The approval is based on Phase 3 ENHANCE-1 trial data showing superior efficacy: 89.0% composite clinical cure rate versus 68.4% for meropenem. The drug targets multidrug-resistant Gram-negative bacteria and previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations. Notably, ZAYNICH is described as the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval. The drug was also approved by India's DCGI on May 27, 2026, and a Marketing Authorization Application is pending with the European Medicines Agency.
This FDA approval represents a significant milestone for Wockhardt, validating years of R&D investment and positioning the company to enter the multi-billion dollar global antibiotic market. The first-in-class status could drive meaningful revenue growth, while the QIDP designation may provide additional market exclusivity benefits.