Soligenix Announces Key Safety Milestone in Phase 3 FLASH2 Trial of HyBryte™ for Cutaneous T-Cell Lymphoma; Enrollment Progress on Track

Reuters

Oct 07

Soligenix Announces Key Safety Milestone in Phase 3 FLASH2 Trial of HyBryte™ for Cutaneous T-Cell Lymphoma; Enrollment Progress on Track

Soligenix Inc. has announced progress in its confirmatory Phase 3 clinical trial of HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). The company reported that the first Data Monitoring Committee meeting found no safety concerns, confirming an acceptable safety profile consistent with previous studies. Patient enrollment for the FLASH2 study is proceeding as planned, with an enrollment update expected in the fourth quarter of 2025. A pre-specified blinded interim efficacy analysis is targeted for the first half of 2026, and topline results are anticipated in the second half of 2026. No efficacy results from this ongoing study have been presented yet.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Soligenix Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH91092) on October 07, 2025, and is solely responsible for the information contained therein.

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Soligenix Inc. has announced progress in its confirmatory Phase 3 clinical trial of HyBryte  for the treatment of cutaneous T-cell lymphoma . The company reported that the first Data Monitoring Committee meeting found no safety concerns, confirming an acceptable safety profile consistent with previous studies. Patient enrollment for the FLASH2 study is proceeding as planned, with an enrollment update expected in the fourth quarter of 2025. A pre-specified blinded interim efficacy analysis is targeted for the first half of 2026, and topline results are anticipated in the second half of 2026. No efficacy results from this ongoing study have been presented yet.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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