Soligenix Disappointed with FLASH2 Study Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 08 2026
0mins
"We remain disappointed with the unanticipated outcome of the FLASH2 study," stated Christopher Schaber, PhD, President and CEO of Soligenix. "Despite the fact that HyBryte demonstrated statistically significant reductions in cutaneous T-cell lymphoma lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency and the Food and Drug Administration."
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About SNGX
Soligenix, Inc. is a late-stage biopharmaceutical company, which is focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company’s segments include Specialized Biotherapeutics, and Public Health Solutions. Its Specialized BioTherapeutics business segment is engaged in developing and focused on the commercialization of HyBryte (a proposed name of SGX301), a novel photodynamic therapy (PDT), utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). Its Public Health Solutions segment includes development programs for RiVax, its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic-resistant and emerging infectious diseases and its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Market Opportunities and Challenges: With the ongoing Bundibugyo virus outbreak in the Democratic Republic of Congo and Uganda, Soligenix's vaccine development not only addresses the current public health crisis but also presents new market opportunities for the company, despite facing uncertainties related to funding and regulatory approvals.
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- Thermal Stability Advantage: The ThermoVax® platform enables the vaccines to remain stable for at least two years at temperatures up to 40 degrees Celsius, simplifying storage and distribution logistics, and providing a safer option for global vaccination efforts.
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See More
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- Strong Immune Response: The bivalent and trivalent vaccines developed in collaboration with the University of Hawai?i have achieved up to 100% protection in non-human primates, demonstrating their efficacy and long-term stability against lethal virus challenges.
- Logistics Simplification: The ThermoVax technology allows vaccines to remain stable for at least two years at temperatures up to 40 degrees Celsius, eliminating the need for ultra-cold storage, thus simplifying global vaccination logistics in outbreak regions like Africa.
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- Escalating Pandemic Impact: With the Ebola outbreak intensifying in the Democratic Republic of Congo and Uganda, the WHO has classified it as a public health emergency of international concern, increasing the urgency for vaccine development and further elevating Soligenix's visibility in the market.
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