Biocon share price jumps over 4% after US FDA clears Malaysian insulin facility

Biocon share price surged 4.5% during Monday's session following the clearance from the US Food and Drug Administration (US FDA) for the insulin facility of Biocon Biologics in Malaysia. This development marks the resolution of a significant regulatory bottleneck for the company.

After the Malaysian unit was designated as a "Voluntary Action Indicated" (VAI) by the US drug authority, the business was able to proceed with filing products from that facility. It follows the unit's October 2023 designation as an Official Action Indicated (OAI). Furthermore, when the US authority inspected the facility last September, it also received five observations.

The company announced in an exchange filing that the recent cGMP inspection conducted by the agency took place from September 15 to September 27, 2024. The scope of the inspection covered multiple facilities, including one Drug Substance manufacturing unit, one Drug Product manufacturing unit, one Medical Device Assembly unit, one Analytical Quality Control Laboratory, two Microbiological Control Laboratories, and two Warehouses.

Recent media reports indicate that Bank of America Securities has raised its price target for Biocon by approximately 9%, increasing it to ₹435 while maintaining a 'buy' recommendation on the stock. This adjustment comes in light of the successful clearance of Biocon's major manufacturing facilities in Bengaluru and Malaysia, which enhances confidence in its upcoming biosimilar launch pipeline.

In November 2024, the USFDA granted a VAI status to Biocon Biologics' Bengaluru facility, prompting attention to shift towards securing regulatory approval for the Malaysian unit. Additionally, Bank of America Securities has projected a rise in annualized revenue, estimating it will increase from $1 billion in the first half of FY25 to $1.2 billion in FY26. Looking ahead, the brokerage anticipates that the focus will now transition towards deleveraging and the performance of new product launches for Biocon.

Biocon share price today

Biocon share price today opened at ₹370.50 apiece on the BSE, the stock touched an intraday high of ₹376.95 apiece and an intraday low of ₹364.40 per share.

Riyank Arora, Technical Analyst, Mehta Equities Ltd stated that Biocon share price is trading in a positive trend with strong support at ₹360 and resistance at ₹390- ₹400. A breakout above ₹400 could signal further upside momentum. The stock is well-supported by bullish volume and RSI, indicating strength. Traders can buy on dips near ₹360- ₹365 with a stop loss at ₹355, targeting ₹390- ₹400 and beyond.

Disclaimer: The views and recommendations above are those of individual analysts, experts and broking companies, not of Mint. We advise investors to check with certified experts before making any investment decision.