The company has submitted an abbreviated new drug application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of Novartis’ Tabrecta (Capmatinib hydrochloride), it said in a regulatory filing.
The drug firm believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV Certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of the potential launch of the product under certain circumstances, it added.
Industry estimates show that Tabrecta recorded sales of USD 126 million in the US market for 2023, translating to Rs 1,056 crore at the current dollar-rupee exchange rate.
Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.Also Read: Unstoppable bulls! Sensex, Nifty scale fresh peaks tracking positive global cues
At 11:00 am, the scrip was trading 3.5% higher at Rs 1,551.4 on BSE. Meanwhile, the stock has also delivered nearly 90% returns year-to-date, while it has rallied over 150% in the past two years.
In technical terms, the relative strength index (RSI) of the stock is currently at 61.1. An RSI below 30 is considered oversold, and above 70 is overbought, Trendlyne data showed. The stock is trading higher than the 10-day, 20-day, 30-day, 50-day, 100-day, 150-day and 200-day simple moving averages (SMAs).
Meanwhile, Foreign Institutional Investors (FIIs) increased their stake in the firm from 11.03% in the June quarter of 2023 to 17.45% in the same quarter of 2024. Conversely, Mutual Funds (MFs) reduced their stake from 9.45% in June 2023 to 2.67% in June 2024.
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