 "Cipla rallies 4% on US FDA approval to market Lanreotide injection")
Cipla stock rises: Shares of pharmaceutical compay Cipla rallied 4 per cent to Rs 1,494.80 on the BSE in Wednesday’s intra-day trade.
The surge came after the company said that it has received a final approval from the United States Food and Drugs Administration (US FDA) for lanreotide injection.
The surge came after the company said that it has received a final approval from the United States Food and Drugs Administration (US FDA) for lanreotide injection.
The approval for the generic version of Lanreotide Acetate is in line with Cipla’s growth strategy in the complex product segment and will strengthen Cipla's position in the US market.
Cipla USA Inc., wholly owned subsidiary of the Company in USA has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from USFDA, Cipla said in exchange filing.
Cipla’s Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline® Depot (lanreotide) Injection and is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEPNETs), the company said.
According to IQVIA (IMS Health), Somatuline® Depot (Lanreotide) had US sales of approximately $898 million for the 12-month period ending March 2024.
At 01:55 PM, Cipla stock was trading 3.4 per cent higher at Rs 1,492.30, as compared to 0.25 per cent rise in the S&P BSE Sensex. In past three trading days, the stock soared 7 per cent. It had hit a 52-week high of Rs 1,519 on March 11, 2024.
Meanwhile, analysts at ICICI Securities have ‘buy’ rating on Cipla with target price of Rs 1,645 per share.
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More than Q4FY24 numbers, the key takeaway was an upbeat management commentary where the management has given aggressive Ebitda margins guidance of 24.5 per cent-25.5 per cent for financial year 2025 (FY25). The guidance is based upon strong India growth, differentiated and complex launches in the US and strong South Africa momentum. Interestingly, the margin guidance is devoid of any adverse outcome of US FDA embargo and a possible delay in key US launches.
The company already has plan B in place to address the launches from other sites. US launches would be mainly confined to complex areas of peptides and respiratory assets.
The brokerage firm, however, believes the management’s confidence is stemming from successful recent launches in the US and a long-drawn India strategy with a blend of branded Rx- Trade Generics- Consumer Health.
The brokerage firm, however, believes the management’s confidence is stemming from successful recent launches in the US and a long-drawn India strategy with a blend of branded Rx- Trade Generics- Consumer Health.