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Back-to-Back USFDA Approvals Boost Zydus Lifesciences, Shares Hit 8-Month High

Zydus Lifesciences' drug hit an eight-month high following a string of US regulatory approvals.

Zydus Lifesciences’ drug hit an eight-month high following a string of US regulatory approvals. The stock hit Rs 426 on the NSE on October 7 and was last seen on January 17.


The company has received final and provisional approvals from the US Food and Drug Administration for its eight abbreviated new drug applications (ANDAs) since August 31. The company has now received 326 approvals from 428 ANDAs since June 30, 2022.


The stock has risen 10% over the past five sessions after securing four USFDA approvals in a week. It has risen 12% in the past month, outpacing Cipla, Dr Reddy’s Laboratories and Sun Pharmaceutical Industries. However, Zydus Lifesciences stock is still down 11% in 2022. The US accounts for 40% of the company’s revenue, which is why every FDA approval is positive.


On September 12, Cariprazine capsules received final approval and an exclusive 180-day exclusivity. It has annual US sales of $2.39 billion and is used to treat schizophrenia. On September 13, Lenalidomide capsules for treating various cancers were finally approved. Its annual sales in the US are $2.86 billion.


On September 16, Sugammadex Injection received preliminary approval. Its annual US sales are $772 million. It is used to reverse neuromuscular blockade in adults undergoing surgery. On October 3, the final approval and 180-day shared exclusivity for Mirabegron extended-release tablets for the treatment of overactive bladder. Its annual sales in the US are $2.42 billion.

On October 6, Brivaracetam tablets, with annual US sales of $412 million, for treating partial-onset seizures in children four years of age and older, received final approval and 180-day co-exclusivity.


Investors are now bullish on opportunities presented by the generic cancer drug Revlimid. Revlimid is the brand/trade name for lenalidomide, which Zydus launched on September 20, a week after final approval. The drug works by slowing or stopping the growth of cancer cells.


Anand Rathi has a “hold” rating on the stock with a price target of Rs 440, while Prabhudas Lilladher has a “buy” rating with a target price of Rs 425.

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