Stella Pharma's application for approval of its BNCT drug Steboronin is scheduled for review by the Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs and Food Sanitation Council following a partial amendment to add recurrent meningioma as an indication. The stock's reaction after the announcement was reportedly limited.
The report, published as prefectural news, says Stella Pharma is proceeding with an application for partial amendment to the marketing approval of its boron neutron capture therapy (BNCT) drug “Steboronin,” adding recurrent meningioma as an indication. The application is scheduled for review by the Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs and Food Sanitation Council.
In the Phase II trial, progression-free survival was 14.4 months, exceeding the 1.4 months recorded in the control group, and the response rate was reported at 27.3%. The drug had previously received orphan drug designation in September 2024 and been designated for priority review in February 2026, and the review is reportedly proceeding under the priority review system.