SPARC shares zoom 34% in two days on favourable US court ruling

Shares of Sun Pharma Advanced Research Company Ltd (SPARC) continued their strong upward move for the second consecutive session on Wednesday, surging 11.42 per cent to hit a high of Rs 179.50. At this level, the stock has advanced 33.71 per cent in two trading days.

The strong upmove follows a favourable ruling from a US court regarding the Priority Review Voucher (PRV) associated with its product, Sezaby.

The company, in a BSE filing, 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 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 pharmaceutical company.