Cipla closes in on 52-week high on getting USFDA nod for cancer drug

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26 Aug, 2025 12:21

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Shares of Cipla gained on September 7 after the drug maker announced that it received the final approval from the US drug regulator to launch the generic version of a rare blood cancer medicine.

The United States Food and Drug Administration (US FDA) had approved its Abbreviated New Drug Application (ANDA) for Lenalidomide capsule 5 mg, 10 mg, 15 mg and 25 mg, the pharma company said in a regulatory filing.

Cipla’s Lenalidomide Capsules are AB-rated therapeutic equivalent generic versions of Bristol Myers Squibb’s (Celgene) Revlimid (Lenalidomide) Capsules.

Lenalidomide is used in the treatment of multiple myeloma, a cancer of plasma cells. Apart from that, the immunomodulatory prescription drug, which suppresses the immune system, is indicated for several other blood- related malignancies in adults such as myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma and marginal zone lymphoma.

Depending on the type of cancer, it can be used as monotherapy or in combination as a part of the first-line regimen, maintenance regimen or relapsed settings, Cipla said in a release.

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According to external data that Cipla provided, Revlimid (Lenalidomide) capsules had US sales of approximately $2.58 billion for the 12-month period ending June 2022.

"The product will be available for shipping soon," said Cipla.

Following the disclosure, the stock rose about 2 percent to Rs 1,062, which is close to its 52-week high of Rs 1,083 hit in March.

Analysts, however, have a lukewarm stance on the stock.

Motilal Oswal said in a note in August that enhanced effort was required to improve return ratios. It has a target price of Rs 950 on the counter.

“We maintain our neutral rating on the stock due to stable return ratios over the next two years. The current valuation adequately factors in the earnings upside over the next couple of years,” the broker said.

KR Choksey Institutional, which has set the target price at Rs 1,080, said Cipla’s strong product launches in the US and India are key positives.

“US growth trajectory continues to be strong, driven by respiratory, complex generics, and peptide products. We expect its net income to grow at a 16.5 percent CAGR (vs. an earlier estimate of 20.2 percent over FY22-FY24E) over FY22-FY25E driven by complex generic and respiratory specialty products launches and cost optimization focus,” it said.

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