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 biopharmaceutical company announced the milestone alongside updated analysis from Zacks Small-Cap Research, which expressed strong conviction about the 50-patient enrollment achievement and encouraging clinical results. The overall blinded response rate currently stands at 48% for patients who have completed treatment in the FLASH2 trial, providing significant confidence that the trial is trending in the right direction according to the research report published on November 20, 2025.
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. This 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 as the company moves toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma.
The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte, with successful completion of the second Phase 3 study leading to regulatory approvals being 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.
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. 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.
