Soligenix Inc. (NASDAQ: SNGX) has reached a significant enrollment milestone in its ongoing confirmatory Phase 3 FLASH2 trial for HyBryte™, a novel photodynamic therapy for treating cutaneous T-cell lymphoma. The company recently received updated analysis from Zacks Small-Cap Research following this announcement, with the overall blinded response rate standing at 48% for patients who have completed treatment.
In a research report published on November 20, 2025, Zacks Small-Cap Research expressed strong conviction about the 50-patient 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 second quarter 2026 interim analysis represents the next major catalyst for Soligenix, according to the Zacks report. The analysis expresses confidence that the trial is trending in the right direction based on the 48% blinded response rate, stating that this update provides substantial confidence in the trial's progress. 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.
Soligenix is developing HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, a rare cancer affecting the skin. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. The company's development programs also include expansion of synthetic hypericin into psoriasis, and its first-in-class innate defense regulator technology, dusquetide, for treating inflammatory diseases including oral mucositis in head and neck cancer.
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. These programs incorporate the company's proprietary heat stabilization platform technology, ThermoVax®, and have been supported with government grants and contract funding from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority.
For further information about the company, visit www.Soligenix.com. The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX. To view the full article discussing the Zacks analysis, visit https://ibn.fm/e9XQ5.
