Zydus Lifesciences Shares Jump 3% After US FDA Approval for Apalutamide Tablet Production

Zydus Lifesciences has recently made headlines with a notable 3% increase in its stock price, peaking at Rs 930 following the announcement of a significant regulatory milestone. The company has secured approval from the U.S. Food and Drug Administration (FDA) to produce Apalutamide Tablets, specifically in the 60 mg dosage. By mid-afternoon, the stock adjusted slightly, trading at Rs 910.40, which still reflects a respectable 0.9% rise on the day.

Zydus Gains FDA Approval

In an official communication, Zydus Lifesciences declared, "We are pleased to announce that we have received the final approval from the USFDA for the manufacture of Apalutamide Tablets, 60 mg (marketed as Erleada®)." This approval paves the way for Zydus to enhance its portfolio in oncology treatments.

Apalutamide is a targeted therapy that blocks androgen receptors and is approved for patients suffering from metastatic castration-sensitive prostate cancer.
The tablets will be manufactured at Zydus’s facility located in the Special Economic Zone (SEZ) in Ahmedabad.
Last year, Apalutamide tablets generated an impressive $1,099.8 million in sales within the U.S. market.

Strong Q3 Performance

Zydus Lifesciences also revealed robust financial results for the third quarter of FY25. The company’s consolidated net profit surged 30% year-on-year, reaching Rs 1,024 crore. Revenue from operations saw a 17% increase, totaling Rs 5,269 crore, primarily driven by a 31% rise in sales from its largest market, the United States. This marks a significant improvement compared to the previous year when the company reported a net profit of Rs 4505 crore. On a quarter-over-quarter basis, revenue grew modestly by 0.6%.

Market Performance Comparison

Over the past five trading days, Zydus Lifesciences shares have appreciated by 1.8%. However, the stock has experienced a 14% decline over the past six months, and a 6% drop in the past year. In contrast, the Nifty 50 index has shown a slight increase of nearly 2% in the last five days, despite a 0.1% dip over the past month and a notable 10% decrease over the last six months. Year-over-year, the Nifty 50 has registered a 5% gain.

Summary of Key Points

Zydus Lifesciences stock peaked at Rs 930 after FDA approval.
Apalutamide is a treatment for metastatic castration-sensitive prostate cancer.
Q3 results: 30% net profit increase year-over-year.
Zydus shares have fluctuated, showing a 1.8% rise in the last week but a 14% fall over six months.

This recent approval and financial performance underscore Zydus Lifesciences’ commitment to expanding its footprint in the pharmaceutical industry, particularly in oncology. Investors will be keen to monitor how these developments impact the company’s future growth trajectory.