Biocon gets USFDA approval for Everolimus tablets; check stock reaction
In an exchange filing, the company said the approval covers Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths.
- Jan 12, 2026,
- Updated Jan 12, 2026 9:35 AM IST
Biocon Ltd on Monday said its wholly owned subsidiary, Biocon Pharma Ltd, has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for oral suspension.
In an exchange filing, the company said the approval covers Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths.
According to the filing, Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged one year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA). The product is also approved for the adjunctive treatment of adult and pediatric patients aged two years and older with TSC-associated partial-onset seizures.
Biocon further stated that the approval will further strengthen its portfolio of vertically integrated drug products.
Despite the announcement, the stock traded on a lower note today. Last checked, it was down 0.96 per cent at Rs 376.
On the technical front, the scrip traded below its 5-day, 10-, 20-, 30-day and 50-day simple moving averages (SMAs) but above its 100-day, 150-day and 200-day SMAs. Its 14-day relative strength index (RSI) came at 38.33. A level below 30 is defined as oversold while a value above 70 is considered overbought.
BSE data shows that Premier Energies is trading at a standalone and consolidated price-to-earnings (P/E) ratio of 84.88 and 74.37, respectively, with a price-to-book (P/B) value of 5.21. The company reported standalone and consolidated earnings per share (EPS) of 4.43 and 5.06, while its return on equity (RoE) stood at 6.13.
According to Trendlyne, the stock has a one-year beta of 1.23, indicating high volatility.
As of December 2025, promoters held a 48.27 per cent stake in Biocon, 6.18 per cent lower compared to the previous quarter.
Biocon Ltd on Monday said its wholly owned subsidiary, Biocon Pharma Ltd, has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for oral suspension.
In an exchange filing, the company said the approval covers Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths.
According to the filing, Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged one year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA). The product is also approved for the adjunctive treatment of adult and pediatric patients aged two years and older with TSC-associated partial-onset seizures.
Biocon further stated that the approval will further strengthen its portfolio of vertically integrated drug products.
Despite the announcement, the stock traded on a lower note today. Last checked, it was down 0.96 per cent at Rs 376.
On the technical front, the scrip traded below its 5-day, 10-, 20-, 30-day and 50-day simple moving averages (SMAs) but above its 100-day, 150-day and 200-day SMAs. Its 14-day relative strength index (RSI) came at 38.33. A level below 30 is defined as oversold while a value above 70 is considered overbought.
BSE data shows that Premier Energies is trading at a standalone and consolidated price-to-earnings (P/E) ratio of 84.88 and 74.37, respectively, with a price-to-book (P/B) value of 5.21. The company reported standalone and consolidated earnings per share (EPS) of 4.43 and 5.06, while its return on equity (RoE) stood at 6.13.
According to Trendlyne, the stock has a one-year beta of 1.23, indicating high volatility.
As of December 2025, promoters held a 48.27 per cent stake in Biocon, 6.18 per cent lower compared to the previous quarter.