Soligenix, Inc. announced that it has received agreement from the US Food & Drug Administration (FDA) on an initial pediatric study plan (iPSP) for HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). The agreed iPSP stipulates that Soligenix intends on requesting a full waiver of pediatric studies upon submission of a new drug application (NDA). Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.