Business News: Zydus Lifesciences Ltd’s shares rose by up to 1% in early trading on September 30, following the company’s final approval from the US Food and Drug Administration (FDA) for its prostate cancer drug, Enzalutamide Capsules (40 mg), despite a generally quiet market.

The stock reached Rs 1,088.85 after the market opened, building on the previous session’s 0.74% gain. Over the past year, Zydus Life’s share price has surged by 76%, pushing the company’s market capitalization above Rs 1.1 lakh crore, outperforming the NSE Nifty 50, which grew by 34% during the same period. However, the stock has dropped around 17% since August due to profit booking and rising competition.

The FDA approval is notable as Enzalutamide capsules are used to treat metastatic castration-resistant prostate cancer. The drug will be produced at Zydus’ Moraiya facility in Ahmedabad. In the US, Enzalutamide capsules reportedly generated $869.4 million in sales over a year, and projections suggest that it could be part of a market expected to reach $14.2 billion by 2029.

Earlier this month, Zydus Life also garnered attention due to a ruling from the US Court of Appeals for the Federal Circuit regarding a patent dispute over the drug Mirabegron. The court found that a lower court had made an error when invalidating the patent. Zydus and Lupin are currently the only companies offering generic Mirabegron, which is used to treat overactive bladder (OAB). Astellas Pharma, the original manufacturer of Mirabegron, had sued to block the generics but was denied an injunction in April 2024. Both Zydus and Lupin have launched the 25 mg dosage in the US and plan to introduce the 50 mg dosage soon.