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.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.