Soligenix Advances Phase 3 FLASH2 Trial for HyBryte in Cutaneous T-Cell Lymphoma

Reuters
Feb 12
Soligenix Advances Phase 3 FLASH2 Trial for HyBryte in Cutaneous T-Cell Lymphoma

Soligenix Inc. has provided an update on its ongoing clinical development of HyBryte™ (SGX301 or synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). The company is conducting the FLASH2 confirmatory Phase 3 clinical trial, which is actively enrolling patients. As of February 10, 2026, 66 out of the planned 80 patients have been enrolled. An interim analysis is planned for the second quarter of 2026, with top-line results from the trial expected in the second half of 2026. No final results have been presented yet. The FLASH2 study is designed to replicate the company's first successful Phase 3 FLASH trial, with a modification to the primary endpoint assessment period.

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