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Soligenix's HyBryte Therapy Advances as NetworkNewsAudio Highlights Urgent Need for Rare Disease Treatments

By FisherVista

TL;DR

Soligenix's HyBryte nearing final trial completion offers investors potential advantage in rare disease market with over 30 million affected Americans lacking FDA-approved therapies.

Soligenix's HyBryte uses synthetic hypericin sodium in photodynamic therapy with visible light, now in final confirmatory Phase 3 trial before global regulatory submissions.

Soligenix's treatments for rare diseases like cutaneous T-cell lymphoma address unmet medical needs for millions, making tomorrow better through accessible therapies for chronic conditions.

Soligenix develops HyBryte for cutaneous T-cell lymphoma using visible light therapy and also works on ricin and COVID-19 vaccines with heat stabilization technology.

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Soligenix's HyBryte Therapy Advances as NetworkNewsAudio Highlights Urgent Need for Rare Disease Treatments

Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases, is featured in a new NetworkNewsAudio APR addressing the critical need for therapies targeting chronic rare conditions in an aging population. The audio presentation, titled "Chronic Rare Diseases in an Aging America: Why HyBryte and Federal Policy Matter Now," emphasizes that more than 30 million Americans suffer from rare diseases, with most lacking FDA-approved treatment options.

The company's lead candidate, HyBryte(TM) for cutaneous T-cell lymphoma (CTCL), has reached a pivotal stage in development, currently undergoing the final confirmatory trial required before global marketing submissions. This advancement positions Soligenix at a critical juncture as the current administration advances new health policy initiatives specifically addressing chronic and rare diseases. The timing of this development is particularly significant given the growing impact of these conditions on older adults across the nation.

Soligenix's Specialized BioTherapeutics business segment focuses on developing HyBryte(TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for CTCL treatment. Following successful completion of the second Phase 3 study, the company plans to seek regulatory approvals to support potential worldwide commercialization. Additional development programs in this segment include expanding synthetic hypericin (SGX302) into psoriasis treatment and advancing first-in-class innate defense regulator technology through dusquetide (SGX942) for inflammatory diseases including oral mucositis in head and neck cancer, and SGX945 for Behçet's Disease.

The company's Public Health Solutions business segment maintains active vaccine development programs supported by government funding from agencies including the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA). These programs include RiVax(R) ricin toxin vaccine candidate, filovirus vaccines targeting diseases like Marburg and Ebola, and CiVax(TM) for COVID-19 prevention, all incorporating the proprietary ThermoVax(R) heat stabilization platform technology.

The NetworkNewsAudio feature underscores the broader implications of Soligenix's progress, highlighting how advancements in rare disease treatments intersect with evolving federal health policies and address substantial unmet medical needs. With rare diseases affecting millions of Americans and disproportionately impacting aging populations, the development of therapies like HyBryte represents both a medical advancement and a response to growing public health challenges. The full press release detailing this development is available at https://ibn.fm/mnTOI, while ongoing updates relating to SNGX are maintained in the company's newsroom at https://ibn.fm/SNGX.

This convergence of pharmaceutical advancement and policy attention creates a significant moment for rare disease treatment development, potentially establishing new pathways for addressing conditions that have historically received limited research investment and therapeutic options. The progress of HyBryte through final clinical trials demonstrates how targeted biopharmaceutical development can address specific gaps in treatment availability, particularly for conditions like cutaneous T-cell lymphoma that affect vulnerable patient populations.

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FisherVista

FisherVista

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