BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Reports Positive Safety Review from DMC in Ongoing Phase 3 FLASH2 Study of HyBryte for CTCL 

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases, announced that its Data Monitoring Committee has completed its first review of the confirmatory Phase 3 FLASH2 study of HyBryte(TM) (synthetic hypericin) in cutaneous T-cell lymphoma, concluding there are no safety concerns and that the therapy maintains an acceptable safety profile consistent with prior trials. Enrollment is progressing on schedule, with an update expected in Q4 2025 and a blinded interim efficacy analysis planned for 1H 2026. The FLASH2 trial builds on the Company’s earlier statistically significant Phase 3 results and additional supportive studies demonstrating HyBryte’s efficacy and tolerability as a potential first-line treatment option for early-stage CTCL.

To view the full press release, visit https://ibn.fm/o0Xgw

About Soligenix

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behcet’s Disease.

Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX

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