Soligenix Announces Safety Milestone In HyBryte Phase 3 Study, Stock Climbs In Pre-Market

(RTTNews) - Tuesday, Soligenix, Inc. (SNGX) announced its first Data Monitoring Committee meeting has concluded that there are no safety concerns with the ongoing Phase 3 study, evaluating HyBryte for the treatment of cutaneous T-cell lymphoma.

The Committee further found that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies.

The company added that it intends to provide an update about the patient enrollment in the fourth quarter of 2025, while supporting the Committee to undertake a pre-specified blinded interim efficacy analysis of Flash 2 study in the first half of 2026.

Moreover, it expects to complete the study on schedule with topline results in the second half of 2026.

"In the Phase 3 FLASH study, HyBryte was shown to be efficacious in early-stage CTCL with a promising safety profile," stated Ellen Kim, Lead Investigator of the FLASH2 study.

In the pre-market hours, SNGX is climbing 17.43 percent, to $1.61 on the Nasdaq.