Soligenix receives FDA Refusal to File for HyBryte NDA in CTCL

SOLIGENIX, INC.

FDA issued Refusal to File (RTF) letter for HyBryte NDA for early-stage cutaneous T-cell lymphoma.
NDA submitted Dec 14, 2022 deemed not sufficiently complete for substantive review.
Soligenix plans to request a Type A meeting to clarify issues and seek guidance for resubmission.
Cutaneous T-cell lymphoma is a rare cancer affecting over 25,000 patients in the U.S.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.