Soligenix Inc. has reached a significant enrollment milestone in its ongoing confirmatory Phase 3 FLASH2 trial for HyBryte, a treatment for cutaneous T-cell lymphoma. The New Jersey-based biopharmaceutical company, which focuses on developing products for rare diseases with unmet medical needs, announced the milestone alongside updated analysis from Zacks Small-Cap Research.
The research report published on November 20, 2025, expressed strong conviction about the 50-patient enrollment milestone and encouraging clinical results, while noting puzzlement at the market’s subdued response. The overall blinded response rate currently stands at 48% for patients who have completed treatment in the FLASH2 trial. According to the Zacks report, this update provides significant confidence that the trial is trending in the right direction.
Zacks maintains its $25 per share valuation for Soligenix based on a probability-adjusted discounted cash flow model that considers potential future revenues from the company’s product pipeline. The valuation specifically accounts for HyBryte along with other pipeline candidates including SGX302 and SGX945. With no changes to the financial model following the enrollment milestone, the $25 per share valuation represents the report’s view that the risk-reward profile remains attractive for investors willing to accept the inherent uncertainties of late-stage clinical development.
The second quarter 2026 interim analysis represents the next major catalyst for Soligenix. The company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. 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 into psoriasis, the company’s first-in-class innate defense regulator technology, dusquetide 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, its ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses and CiVax, the company’s vaccine candidate for the prevention of COVID-19.
For further information about the company’s developments, visit their website at https://www.Soligenix.com. The latest news and updates relating to Soligenix are available in the company’s newsroom at https://ibn.fm/SNGX. The development of Soligenix’s vaccine programs incorporates the use of its proprietary heat stabilization platform technology known as ThermoVax, with this business segment supported by government grants and contract funding from multiple agencies including the National Institute of Allergy and Infectious Diseases.
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