Shares of Sun Pharma Advanced Research Co Ltd. (SPARC) surged as much as 20% on Tuesday after a US District Court ruled in favor of the company regarding a Priority Review Voucher (PRV) for its neonatal seizure treatment, Sezaby.

Court Ruling Details

In an exchange filing, SPARC stated that the US District Court for the District of Columbia granted its motion for summary judgment. The court held that the US Food and Drug Administration’s (FDA) withholding of the PRV was “contrary to law” because no previously approved drug product contained phenobarbital sodium as defined by statute. The ruling allows 60 days for an appeal.

Anil Raghavan, CEO of SPARC, said the company was “pleased with the ruling as it validates the company's long-held position on the matter.”

About Sezaby

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.

Stock Movement

SPARC shares were trading 14.6% higher at ₹153.78 apiece around 12:40 PM. Despite today’s sharp gains, the stock remains down 23.4% year-to-date.