Soligenix Achieves Important Safety Milestone in its Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma

FLASH 2 Study Interim Efficacy Analysis Targeted for 1H2026

Enrollment Update Remains on Track for 4Q2025

PRINCETON, N.J., Oct. 7, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its first Data Monitoring Committee (DMC) meeting for its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. The confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (protocol # HPN-CTCL-04) and an ongoing investigator-initiated study (protocol # RW-HPN-MF-01), each further supporting the design of the FLASH2 clinical trial. With enrollment proceeding well, Soligenix anticipates providing an enrollment update in 4Q2025 and supporting the DMC in undertaking a pre-specified blinded interim efficacy analysis in 1H2026.

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