Plus Therapeutics Up 6.7% FDA Orphan Nod

Plus Therapeutics shares jumped 6.7% after FDA granted Orphan Drug Designation to REYOBIQ for pediatric malignant gliomas and ependymoma.
Orphan designation provides seven-year market exclusivity, tax credits for trial costs, and fee exemptions for therapies targeting <200,000 US patients.
FDA also cleared Plus Therapeutics’ IND to evaluate REYOBIQ in pediatric glioma and ependymoma, building on Phase 1/2 data and a Type B meeting.
Orphan designation expands beyond original request, now covering pediatric ependymoma, a rare aggressive brain tumor with limited treatment options.