Invenra announced today that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designations (ODD) to its innovative bispecific antibody, INV724, developed for the treatment of neuroblastoma.
“Invenra is deeply committed to advancing INV724 as a potentially transformative treatment for children with neuroblastoma,” Invenra CEO Roland Green said in a statement. “The FDA’s RPDD and ODD designations not only validate our innovative approach but also give us the critical support to fast-track its development in collaboration with potential partners. We are eager to bring this therapy to patients who need it most.”
According to a release, the RPDD and ODD designations afford numerous benefits, such as a transferrable priority review voucher, extended market exclusivity and eligibility for grants and research support.
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