AUSTIN, Texas, August 8, 2025 – via IBN – NetworkNewsAudio announces the Audio Press Release (APR) titled “Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas,” featuring Soligenix Inc. (NASDAQ: SNGX).
To hear the NetworkNewsAudio version, visit LINK
To read the original editorial, visit LINK
Soligenix Inc. is advancing HyBryte, its late-stage therapy for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer that primarily affects older adults. HyBryte has shown strong promise as a first-line treatment option for early-stage CTCL, a market estimated at nearly $1 billion globally, with 70% of that opportunity in the U.S. The therapy has already received orphan drug designations in both the U.S. and Europe, as well as FDA Fast Track status. Unlike traditional treatments that can take a year or more to show efficacy, HyBryte demonstrated statistically significant results in just six weeks in its initial phase 3 trial. A second confirmatory phase 3 study, FLASH2, is now underway in the U.S. and Europe and is designed to provide further validation of HyBryte’s safety and effectiveness, with top-line results expected in 2026.
HyBryte's safety profile stands out in a treatment space where many existing options carry significant side effects, including DNA damage and long-term carcinogenic risks. The therapy’s use of synthetic hypericin activated by non-carcinogenic visible light — rather than ultraviolet light — offers a safer alternative, especially for older patients. With minimal systemic absorption and strong responses across both patch and plaque lesions, HyBryte has the potential to redefine the standard of care for CTCL. Soligenix's advancements in this rare disease area highlight the growing urgency and opportunity in addressing complex conditions that disproportionately affect aging populations.
About Soligenix Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (“SGX301” or synthetic hypericin) 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, the company’s 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 Behçet’s disease.
The company’s Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company’s vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix’s vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants 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”).
For further information, visit the company’s website at Soligenix Inc.
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