Soligenix Inc. has reached a significant enrollment milestone in its ongoing confirmatory Phase 3 FLASH2 trial for HyBryte, a novel photodynamic therapy for cutaneous T-cell lymphoma. The New Jersey-based biopharmaceutical company, which focuses on rare diseases with unmet medical needs, announced that the trial has achieved its 50-patient enrollment target, with a 48% blinded response rate observed among patients who have completed treatment.
In a research report published by Zacks Small-Cap Research on November 20, 2025, analysts expressed strong conviction about the enrollment milestone and encouraging clinical results, while noting puzzlement at the market's subdued response to the news. The report maintains Zacks' $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, including HyBryte, SGX302 and SGX945.
The Zacks report states that "this update gives us a lot of confidence that the trial is at the very least trending in the right direction." With no changes to the financial model following the enrollment milestone, the valuation remains at $25 per share, representing the report's view that the risk-reward profile remains attractive for investors willing to accept the inherent uncertainties of late-stage clinical development.
Looking ahead, 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 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 business and technology leaders monitoring the intersection of healthcare innovation and investment opportunities, Soligenix's progress represents both a potential breakthrough in lymphoma treatment and a case study in how clinical trial milestones translate to market valuation. The maintained $25 per share valuation suggests analysts see substantial upside potential despite the inherent risks of biopharmaceutical development. The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax, which could have broader implications for vaccine distribution and storage globally.
For further information about the company, visit https://www.Soligenix.com. The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX.
