Zydus Life Shares Rise 1% Following $870 Million US FDA Approval for Cancer Drug

Stocks in Zydus Lifesciences Ltd rallied as much as 1% on opening trade on Sept 30, as the US company received final nod from the United States Food and Drug Administration (USFDA) for its prostate cancer medicine -- Enzalutamide Capsules, 40 mg.

As of 11:00 AM IST, on Monday, 30th September, shares of Zydus Lifesciences were going at ₹1,062.20 a piece.

Zydus Lifescience's share price opened at ₹1088.85 soon after opening on the gains of the previous session at 0.74%. The market capitalisation of the company has surged to more than ₹1.1 lakh crore, up 76% in the last one year. 

It outperformed benchmark NSE Nifty 50, which gained 34% in the same period. Of late however, the stock has languished, sliding around 17% since August, mainly on the back of profit booking and competitive pressure.

US FDA approval is crucial as Enzalutamide capsules are being used for the treatment of metastatic castration-resistant prostate cancer. This preparation will be produced at the company's Moraiya, Ahmedabad facility.

Reports have it that Enzalutamide capsules supposedly made $869.4 million in annual sales within the United States in one year. A research report also projected that enzalutamide is one of the two agents, which will reach a combined total sales of $14.2 billion by 2029.

The patent for Mirabegron has attracted attention for Zydus Life shares as the US Court of Appeals for the Federal Circuit ruled, earlier this month that the district court had made legal errors in the way it had invalidated the patent. So far, only Zydus Life and Lupin have dared to risk launching generic Mirabegron.

The patent holder, Astellas Pharma Inc. of Mirabegron has filed a case seeking an injunction that would prevent Zydus and Lupin from filing generic versions alleging patent infringement. A federal judge, however, denied Astellas' motion in April 2024. Mirabegron is utilized during the treatment of OAB and other associated symptoms that include urge urinary incontinence, urgency, and urinary frequency.

Both Zydus Life and Lupin are the first to market the generic version of Mirabegron in dosages of 25 mg in the US market and are gearing up for the launch of 50 mg dosages shortly.

The group now stands at 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the submission process began in FY 2003-04.

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For more than five years, Zydus Lifesciences compounded its earnings per share at 20% per annum. That EPS growth lags the rise in the share price, however: 36% a year over the same time frame. It means that, nowadays, market participants view the company with greater respect. That is hardly surprising, given the track record.

Zydus Lifesciences Ltd (Zydus Lifesciences) was known earlier as Cadila Healthcare Ltd. The company was involved in global lifesciences, discovery, development, manufacturing, and marketing of different healthcare therapies. Some of its principal products for finished dosage formulations with human drug formulations include generic and branded generics, specialty formulations in the form of biosimilars, vaccines, APIs, animal health products, and consumer wellness products.

The company offers its products in therapeutic areas, for example: gastrointestinal, cardiovascular, respiratory, pain management, cancer, inflammation, neurology, and women's health among others. Operations are in the US, Europe, South Africa, Japan, Brazil, and other emerging markets. Zydus Lifesciences has its headquarters in Ahmedabad, Gujarat, India.