Shares of Wockhardt Ltd hit 10% upper circuit on 31 January after the company’s widely used discovery medication Zaynich showed 96.8% efficacy in a Phase III research for a complicated UTI.
In its regulatory filing, the company said, “With respect to clinical cure, Zaynich achieved 96.8% efficacy. Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in last more than 10 years.”
Wockhardt asserted that Zaynich’s combined clinical and microbiologic curative efficacy is the “highest ever” among all FDA-approved novel antibiotics developed in the last “more than 10 years.” Zaynich met the USFDA/EMA and DCGI’s major efficacy findings, and the trial compared it to the broad-spectrum antibiotic meropenem.
Wockhardt now intends to travel to the European Medicines Agency (EMA) to apply for marketing permission and submit a new drug application (NDA) to the USFDA.
As an investigational antibiotic, Zidebactam/Cefepime (Zaynich) belongs to the novel class of “β-lactam enhancers.” Researchers have looked into how well it works to treat acute pyelonephritis and other complicated UTIs.
The pharmaceutical company had previously announced that the Phase III clinical study for Zaynich was due to be completed by the first quarter of 2025. Even before it was officially approved, Wockhardt’s Zaynich had attracted international interest and demanded supplies for compassionate use in the US, UK, France, Australia, and Malaysia.
At 11:32 am, the shares of Wockhardt were trading 9.23% higher at Rs 1,407.10 on NSE.
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