Biocon’s share price rose 4.5% on Monday after the US Food and Drug Administration (US FDA) approved Biocon Biologics’ insulin facility in Malaysia. This development resolves a substantial regulatory impediment for the corporation.
The Malaysian unit was recognized as a “Voluntary Action Indicated” (VAI) by the US drug regulator, allowing the company to file items from that facility. It comes after the unit’s October 2023 classification as an Official Action Indicated (OAI). Furthermore, when the US authorities inspected the facility last September, they made five observations.
The company announced in an exchange filing that the agency’s most recent cGMP inspection took place from September 15 to September 27, 2024. The inspection encompassed a number of facilities, including one drug substance production unit, one drug product manufacturing unit, one medical device assembly unit, one analytical quality control laboratory, two microbiological control laboratories, and two warehouses.
According to media sources, Bank of America Securities has boosted its price objective for Biocon by 9% to ₹435 while maintaining a ‘buy’ recommendation. This revision follows the recent clearance of Biocon’s key manufacturing facilities in Bengaluru and Malaysia, which boosts confidence in the company’s forthcoming biosimilar launch pipeline.
The USFDA granted Biocon Biologics’ Bengaluru facility VAI status in November 2024, attracting attention to the Malaysian unit’s regulatory approval. Bank of America Securities has also anticipated an increase in yearly revenue, anticipating it will rise from $1 billion in the first half of FY25 to $1.2 billion by FY26. Looking ahead, the brokerage expects the attention to shift to deleveraging and the performance of Biocon’s upcoming product launches.
Biocon share price today
Biocon shares began at ₹370.50 on the BSE, reaching an intraday high of ₹376.95 and a low of ₹364.40 per share.
According to Riyank Arora, Technical Analyst at Mehta Equities Ltd, Biocon’s share price is now trending upward, with solid support at ₹360 and resistance at ₹390-₹400. A breach above ₹400 could indicate continued upward momentum. The stock is supported by bullish volume and RSI, which indicate strength. Traders should buy dips between ₹360-₹365 with a stop loss of ₹355, seeking ₹390-₹400 and beyond.
