Biocon stock settles 5% higher after US drug regulator clears Bengaluru API facility unit, stock up 35% YTD

Biocon stock price today: Shares of Kiran Mazumdar Shaw-led Biocon extended gains to settle five per cent higher on Tuesday, December 24, after the United States Food and Drug Administration (USFDA) issued an Establishment Inspection Report (EIR) with a Voluntary Action Status (VAI) for its Active Pharmaceutical Ingredients (API) facility in Bengaluru, Karnataka.

“This is to inform you that the company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA), for our API facility (Site 1), located at Bengaluru, Karnataka, and the inspection stands closed as per 21 CFR20.64(d)(3),” said Biocon in a regulatory filing to the stock exchanges.

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Biocon stock price today

The US drug regulator inspected Biocon's unit between September 16 and September 20, 2024. According to Biocon's statement, the EIR with the VAI status was for site 1 of the Bengaluru unit, and the inspection is closed. 

Shares of the biopharma major rose earlier today when Biocon announced that its European partner, Zentiva, received a decentralised procedure approval in the European Union (EU) for its complex formulation, Liraglutide, used in treating diabetes and weight management.

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Biocon Ltd said in a separate regulatory filing on Tuesday that the approval is for the generic versions of Victoza to treat Type-two Diabetes and Saxenda to treat weight management. Victoza and Saxenda are registered trademarks of Novo Nordisk. 

The decentralised procedure approval authorises medicines in more than one European Union member state in parallel. As per the European Medicines Agency, it can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any member state.

On Tuesday, shares of Biocon opened at ₹332.80 and gained 4.37 per cent higher to hit an intra day high of ₹347.35 against a 52-week high of ₹395.65, before settling 4.63 per cent higher at ₹344.80 apiece on the BSE. Shares of Biocon have risen 35 per cent year-to-date (YTD).

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