BioMedNewsBreaks — Zacks Research Issues Business Update as Soligenix Inc. (NASDAQ: SNGX) Continues Enrollment in Confirmatory Phase 3 HyBryte Trial 

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company targeting rare diseases, was spotlighted this week in a Zacks Small-Cap Research report that presented a favorable analysis, noting that the company’s Phase 3 cutaneous T-cell lymphoma (“CTCL”) study is continuing and that the trial has a high probability of success. 

According to the report, Soligenix is conducting a Phase 3 FLASH2 trial of HyBryte(TM) in patients with CTCL. The Zacks report noted that the FLASH2 trial is similar in design to the recently completed successful Phase 3 FLASH trial. The one key difference between the trials is that in the FLASH trial patients were treated for three cycles of six weeks each, with a two-week break in between cycles. The primary efficacy endpoint for the FLASH trial was measured after the first treatment cycle. 

“In the FLASH2 trial, patients will be treated for 18 consecutive weeks before the primary efficacy endpoint is assessed,” the report noted. “Based on the results from the FLASH trial, we believe the FLASH2 trial has a high probability of success, and we anticipate topline results in 2026.” 

To view the full report, visit https://ibn.fm/I58Bp 

About Soligenix Inc.  

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (“SGX301” or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). 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 (“SGX302”) into psoriasis, the company’s first-in-class innate defense regulator (“IDR”) technology, dusquetide (“SGX942”) 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(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company’s vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix’s vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Defense Threat Reduction Agency (“DTRA”) and the Biomedical Advanced Research and Development Authority (“BARDA”).  

For further information, visit the company’s website at www.Soligenix.com. 

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX 

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