Sun Pharma Advanced Research Company Ltd. (NSE: SPARC), commonly referred to as SPARC, saw its shares hit 20% today after the company announced a significant legal win in the United States. The U.S. District Court for the District of Columbia has granted summary judgment in favour of SPARC regarding the long-disputed Priority Review Voucher (PRV) linked to the approval of its drug Sezaby.
In its ruling, the Court stated that the U.S. FDA’s decision to withhold the PRV was “contrary to law,” noting that no drug product containing phenobarbital sodium had been “previously approved” in the manner defined under the statute. The judgment effectively backs SPARC’s interpretation of the regulatory framework and gives the FDA a 60-day window to file an appeal if it chooses to challenge the decision.
The verdict marks a major milestone for SPARC, especially given the commercial and strategic value that a Priority Review Voucher carries in the pharmaceutical industry. PRVs can accelerate the review timelines for future drug applications or be sold to other companies for substantial sums, making them highly coveted assets.
Reacting to the development, SPARC CEO Anil Raghavan expressed satisfaction with the outcome, saying the ruling aligns with the company’s long-held stance on the issue. His statement underscored the company’s belief that the PRV rightfully belonged to SPARC and that the court’s decision brings long-awaited clarity.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
