Shares of Sun Pharma Advanced Research Co Ltd (SPARC) were locked at 20% upper circuit on 2 December after the company announced that the U.S. court issued a favourable ruling regarding Sezaby’s Priority Review Voucher (PRV). 

The U.S. District Court for the District of Columbia granted SPARC’s motion for summary judgment, ruling that the FDA acted unlawfully by withholding the PRV since no phenobarbital sodium drug had been “previously approved” under the statute. The court also gave the parties 60 days to file an appeal, the company said in its exchange filing.

Sezaby, a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium for injection, which is the first USFDA-approved therapy specifically designed for neonatal seizures. 

The drug fills a critical unmet need in neonatal care and could support SPARC’s long-term growth strategy in the U.S. market.

Following the verdict, investor sentiment improved sharply, as the PRV increased the commercial potential of Sezaby and strengthened SPARC’s competitive positioning. The approval will also accelerate future drug reviews and can also be sold for significant revenue, often ranging between $80 million and $100 million in the U.S. market.

At 3:30 pm, the shares of SPARC closed 19.99% higher at Rs 161.02 on NSE.

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