Soligenix says FDA requires second Phase 3 study for HyBryte NDA after Type A meeting

SOLIGENIX, INC.

FDA refused to file NDA for HyBryte (CTCL); requires positive results from a second clinical study.
Type A Meeting held April 14, 2023; FDA open to protocol discussions for the additional study.
Company disappointed but will collaborate with FDA; evaluating feasibility of conducting the trial.
Phase 3 FLASH study was the largest double-blind, placebo-controlled CTCL trial; met primary endpoint.

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