SPARC shares locked in 20% upper circuit after favourable US court ruling

Shares of Sun Pharma Advanced Research Company (SPARC) were locked in a 20% upper circuit at ₹161 on the National Stock Exchange and BSE after the company informed exchanges that it a court in United States gave a judgement in its favour.

SPARC informed exchanges that US District Court for the District of Columbia granted summary judgment in favour of SPARC in the matter of issuance of Priority Review Voucher (PRV) associated with the approval of Sezaby.

The Court granted SPARC’s motion for summary judgment and held that “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 allowed 60 days to appeal against the motion.

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

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.

Last moth, SPARC resubmitted Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) by Ocuvex Therapeutics Inc. (Ocuvex) for the PDP-716 New Drug Application (NDA).

The PDP-716 Complete Response resubmission addresses the FDA CRL issued in July 2023, stating unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of PDP-716, SPARC said.

PDP-716 is a novel, once daily, ophthalmic suspension of brimonidine tartrate 0.35%. PDP-716 was developed using SPARC’s proprietary TearAct technology

SPARC Q2 earnings

SPARC's net loss narrowed to ₹76 crore in the second quarter of current financial year from loss of ₹108 crore in the year-ago period.

Its revenue from operations dropped 39% in July-September period to ₹7.86 crore as against 12.86 crore in the same period last year.

As of 2:10 pm, SPARC shares were in huge demand as there were a total of 8.99 lakh pending buy orders on the National Stock Exchange while no sellers were visible on the exchange.