Wockhardt Ltd.'s shares surged over 19 per cent on Monday to hit 52-week high after US FDA nod for breakthrough antibiotic Zaynich. The pharmaceutical major secured a key regulatory milestone recently approved by the US Food and Drug Administration, the drug is used for treating complicated urinary tract infections and pyelonephritis, targets drug-resistant bacteria, addressing a growing global challenge as treatment options narrow amid rising antimicrobial resistance.

"The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat
patients facing these aggressive pathogens. The FDA approval of ZAYNICHTM is a monumental step forward
in validating a new option for these underserved populations," said Dennis Deruelle, MD, FHM, Chief
Medical Officer at Wockhardt said in an exchange filing.

The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind,
multicenter study which evaluated the efficacy, safety and tolerability of Zaynichcompared with
meropenem in the treatment of hospitalised adults with cUTI or acute pyelonephritis (AP). Zaynich
demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological
response rate of 89.0% versus 68.4% for meropenem Treatment difference 20.6% (95% CI; 12.3, 29.5).
ZAYNICHTM was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the U.S.,
Europe, LATAM, China and India, and spanned across 64 sites, the company said in an exchange filing.

Notably, Zaynich becomes the first New Chemical Entity (NCE) discovered and developed in India to secure clearance from the US FDA.

Wockhardt Share Price

Wockhardt' share price surged 19.25 per cent on Monday to hit an intraday high of Rs 2,422 apiece, the share later pared gains to trade 11.22 per cent higher at Rs 2,259 apiece.

The company's shares have outperformed the broader Nifty Pharma index. In the past one week, the stock has surged 39.73 per cent, in contrast to a 1.41 per cent decline in the sectoral index. The momentum extends over a one-month period as well, with Wockhardt rallying 63.97 per cent, compared to a modest 4.55 per cent gain in the Nifty Pharma pack.

The strong outperformance is also visible in the year-to-date (YTD) returns, where Wockhardt has risen 60.82 per cent, far ahead of the 7.48 per cent increase seen in the benchmark pharma index. Over a one-year horizon, the stock has gained 56.17 per cent, significantly beating the index return of 13.45 per cent.

Over the longer term, Wockhardt's returns have been exceptional. The stock has skyrocketed 1,257.24 per cent over the past three years, compared to an 89.86 per cent rise in the Nifty Pharma index. Even on a five-year basis, Wockhardt has delivered robust returns of 268.69 per cent, outperforming the sector's 73.04 per cent gains.

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