Sun Pharma Advanced shares hit 20% upper circuit level; here's why

Shares of Sun Pharma Advanced Research Company Ltd (SPARC) surged 20 per cent in Tuesday's trade after a favourable ruling from a US court regarding the Priority Review Voucher (PRV) linked to its product Sezaby. The stock jumped 20 per cent to touch its upper price band of Rs 161.10, although it remains down 19.73 per cent on a year-to-date (YTD) basis.

In a filing to the BSE, the company said the US District Court for the District of Columbia granted summary judgment in favour of SPARC in the matter concerning the issuance of the PRV associated with Sezaby's approval. The court held that the "FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved' as that term is used in the statute" and provided a 60-day window to appeal the decision.

"We are pleased with the ruling issued today by the US District Court, as it validates SPARC's long held position on this matter," SPARC CEO Anil Raghavan said in the statement.

The dispute stemmed from the US Food and Drug Administration's earlier decision to withhold the PRV despite Sezaby's approval. A PRV can significantly accelerate regulatory review timelines for future products, making it a valuable asset for pharmaceutical companies.

Sezaby is a benzyl alcohol and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was approved by the US FDA for the treatment of neonatal seizures.

As of September 2025, promoters held a 65.67 per cent stake in the pharma company.