Soligenix, Inc. - Common Stock (SNGX)

Soligenix (NASDAQ: SNGX) was featured in a BioMedWire editorial titled “Chronic Rare Diseases in an Aging America: Why HyBryte and Federal Policy Matter Now,” which examines the growing burden of rare diseases affecting more than 30 million Americans and the urgent need for new therapies. The article spotlights Soligenix’s late-stage development of HyBryte(TM) (synthetic hypericin) for cutaneous T-cell lymphoma, now in its final confirmatory study before worldwide marketing submissions, and places the Company’s efforts at the intersection of advancing treatment options and emerging national health policy initiatives.

NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- via BioMedWire: — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by BioMedWire ("BMW"), one of 75+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community.

BioMedWire Editorial Coverage : Chronic conditions and rare diseases in the aging population present an urgent and expanding challenge within the U.S. healthcare system, especially as more than 30 million Americans are affected by rare diseases, according to the National Institutes of Health. The vast majority of these conditions lack any FDA-approved treatment, leaving older adults especially vulnerable as age-related symptoms often obscure or delay diagnosis. This rising burden has increased demand for new therapies that can address real unmet need. Soligenix Inc. (NASDAQ: SNGX) ( Profile ), a late-stage biopharmaceutical company, is developing multiple treatments for rare diseases, including HyBryte[TM] (synthetic hypericin) for cutaneous T-cell lymphoma, and is now conducting the final confirmatory clinical study required before filing for worldwide marketing approval. As the Trump administration advances new health policy initiatives affecting chronic and rare diseases, Soligenix’s work sits at a critical intersection of medical innovation and national health priorities. The company is working alongside several leading companies committed to making an impact in the pharmaceutical and life sciences space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and…

AUSTIN, Texas, Dec. 02, 2025 (GLOBE NEWSWIRE) -- BioMedWire: Chronic conditions and rare diseases in the aging population present an urgent and expanding challenge within the U.S. healthcare system, especially as more than 30 million Americans are affected by rare diseases, according to the National Institutes of Health. The vast majority of these conditions lack any FDA-approved treatment, leaving older adults especially vulnerable as age-related symptoms often obscure or delay diagnosis. This rising burden has increased demand for new therapies that can address real unmet need. Soligenix Inc. (NASDAQ: SNGX) (Profile), a late-stage biopharmaceutical company, is developing multiple treatments for rare diseases, including HyBryte[TM] (synthetic hypericin) for cutaneous T-cell lymphoma, and is now conducting the final confirmatory clinical study required before filing for worldwide marketing approval. As the Trump administration advances new health policy initiatives affecting chronic and rare diseases, Soligenix’s work sits at a critical intersection of medical innovation and national health priorities. The company is working alongside several leading companies committed to making an impact in the pharmaceutical and life sciences space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM).

In a pivotal advancement for patients suffering from a rare form of skin cancer, Soligenix (NASDAQ: SNGX) has achieved a critical clinical trial milestone that brings its investigational treatment significantly closer to potential FDA approval. The company announced that is has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80-patient confirmatory Phase 3 clinical trial evaluating HyBryte(TM) (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma ( https://ibn.fm/ZeQoN ).

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Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company specializing in biodefense and rare disease vaccines. The company recently published a peer-reviewed summary of new scientific data demonstrating long-term high-temperature stability of its protein subunit vaccine platform designed for Ebola and Marburg-related viruses. An article discussing this reads, “Soligenix has been developing formulations intended to remain stable even when stored for extended periods at temperatures above 40°C, a capability that could transform global outbreak response readiness. The company’s publication, titled ‘Development of Thermostable Filovirus Vaccines Using Protein Subunit Technology,’ outlines preclinical data showing that the company’s filovirus vaccine antigens, formulated with its proprietary ThermoVax(R) platform, maintained structural integrity and immunogenicity after 12 months of storage at 40°C. The same formulation also outperformed unstabilized comparators that degraded significantly under identical conditions. Most recently, this stability window was increased to at least 2 years (24 months) at 40°C. The publication expands earlier work funded through ongoing U.S. government contracts with BARDA and the National Institute of Allergy and Infectious Diseases.”

Soligenix (NASDAQ: SNGX) is entering a new phase of strategic breadth and influence with the appointment of a seasoned, high-level scientific and policy adviser who brings rarefied experience at the intersection of economics, government and healthcare innovation. The company, a late-stage biopharmaceutical firm developing treatments for rare diseases, has announced the appointment of Tomas J. Philipson, PhD, as strategic advisor, a move that underscores Soligenix’s ambition to accelerate its lead programs and strengthen its regulatory, commercial and scientific positioning ( https://ibn.fm/T1EQ2 ).

In a key development that underscores the advancing clinical trajectory of its lead therapy, Soligenix (NASDAQ: SNGX) announced that the Data Monitoring Committee (“DMC”) overseeing its confirmatory Phase 3 FLASH2 trial of HyBryte(TM) has reported no safety concerns to date, affirming the therapy’s safety profile. Soligenix, a biopharmaceutical company focused on rare diseases and treatments with substantial unmet need, is developing HyBryte (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (“CTCL”) and is now advancing toward critical milestones in 2026.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases with unmet medical need, completed enrollment of the 50 patients required for the interim analysis in its 80-patient confirmatory Phase 3 FLASH2 study evaluating HyBryte (TM) in cutaneous T-cell lymphoma. The interim analysis is slated for the second quarter of 2026, with topline data expected in the second half of the year. The Company noted an overall blinded response rate of 48 percent among patients who have completed treatment to date, exceeding the anticipated 25 percent rate used in the study’s powering assumptions. Investigators report safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases with unmet medical need, completed enrollment of the 50 patients required for the interim analysis in its 80-patient confirmatory Phase 3 FLASH2 study evaluating HyBryte (TM) in cutaneous T-cell lymphoma. The interim analysis is slated for the second quarter of 2026, with topline data expected in the second half of the year. The Company noted an overall blinded response rate of 48 percent among patients who have completed treatment to date, exceeding the anticipated 25 percent rate used in the study’s powering assumptions. Investigators report safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program.

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Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company advancing treatments for rare diseases with unmet medical need, reported third quarter 2025 results and outlined upcoming milestones, including top-line Phase 2a results for SGX302 in psoriasis and an enrollment update for its confirmatory Phase 3 HyBryte(TM) study in cutaneous T-cell lymphoma (CTCL). CEO Christopher J. Schaber, PhD, confirmed that the first Data Monitoring Committee review found no safety concerns for HyBryte(TM), maintaining a consistent safety profile across trials. With $10.5 million in cash as of Sept. 30, 2025, Soligenix expects its operating runway to extend through 2026 while evaluating strategic options to advance its late-stage pipeline.

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Soligenix (NASDAQ: SNGX) is advancing its phase 2a clinical trial of SGX302, a synthetic hypericin therapy for mild-to-moderate psoriasis, building on promising phase 1/2 data. Early results from the trial show encouraging signs of safety and biological activity, highlighting SGX302’s potential as a novel, well-tolerated treatment for a chronic autoimmune skin condition affecting millions globally. Leveraging its experience with hypericin-based therapies, Soligenix aims to address a significant market opportunity, projected to reach $67 billion by 2030, while expanding its dermatology presence. Ongoing trial results could pave the way for larger studies, regulatory guidance, and commercialization.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on rare diseases and biodefense programs, continues to fortify its financial position as it advances toward a series of pivotal and potentially transformational milestones. Following a series of strategic capital initiatives, including a $7.5 million public offering ( https://ibn.fm/QKXcv ), the company now reports a cash runway extending through the end of 2026, providing the resources needed to reach key clinical and regulatory inflection points across its diversified pipeline.

Soligenix (NASDAQ: SNGX), a clinical-stage biotechnology company focused on rare diseases and public health solutions, has rejuvenated its U.S. Medical Advisory Board for cutaneous T-cell lymphoma (“CTCL”), placing fresh expertise and leadership at the center of its HyBryte(TM) development program ( https://ibn.fm/ueKOC ). This strategic move signals the company’s deepening commitment to advancing its pipeline agents in CTCL and aligning clinical strategy with evolving standards of care.

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Current vaccines for Ebola and similar filoviruses face a major deployment barrier: Most require storage between 2°C and 8°C throughout transport, making them vulnerable to spoilage when exposed to the high ambient heat common in many outbreak regions ( https://ibn.fm/MZWfk ). Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company specializing in biodefense and rare disease vaccines, has published a peer-reviewed summary of new scientific data demonstrating long-term high-temperature stability of its protein subunit vaccine platform designed for Ebola and Marburg-related viruses ( https://ibn.fm/F2JpN ).

Soligenix (NASDAQ: SNGX) is continuing to build momentum in the treatment of early-stage cutaneous T-cell lymphoma (“CTCL”) through promising results from its pivotal FLASH trial and ongoing FLASH 2 confirmatory study. HyBryte(TM)—a novel, non-UV light-activated therapy using synthetic hypericin—has demonstrated statistically significant efficacy and safety, offering hope in a field where therapeutic innovation has lagged. In the original FLASH study, nearly half of patients showed meaningful response at 18 weeks, and interim results from an independent University of Pennsylvania study reported a 75% response rate. FLASH 2 builds on these findings with improved design while addressing regulatory requirements for confirmatory evidence. If successful, “HyBryte could become the first approved front-line therapy for early-stage CTCL, reshaping standards of care and strengthening Soligenix’s position as a leader in rare dermatologic oncology.”

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Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on treatments for rare diseases, announced updates to its U.S. Medical Advisory Board for cutaneous T-cell lymphoma (CTCL) to support the ongoing Phase 3 development of HyBryte(TM) (synthetic hypericin). The board, comprised of leading dermatologic and oncologic experts, will provide strategic guidance as Soligenix advances regulatory and commercialization activities for its photodynamic therapy. President and CEO Christopher J. Schaber, PhD, said the addition of new key opinion leaders reinforces the program’s clinical depth and the company’s commitment to bringing HyBryte to CTCL patients worldwide.

Soligenix (NASDAQ: SNGX) recently announced the closing of a $7.5 million public offering, providing the company with additional capital to advance its pipeline ( https://ibn.fm/tCsub ). This funding extends Soligenix’s cash runway through the end of 2026, ensuring that the company has the financial resources to reach key inflection points across its portfolio, including late-stage clinical trials and regulatory milestones. The move underscores Soligenix’s commitment to advancing therapies for rare diseases where there is significant unmet medical need.

Having a loved one diagnosed with cancer can be a very difficult time for that person and those within their immediate circle. It is often difficult to know how to support the patient during their treatment and some people make mistakes in their bid to be supportive. We discuss some suggestions that could be helpful if a loved one is undergoing cancer treatment.

Cutaneous T-cell lymphoma (“CTCL”) is a rare but serious form of non-Hodgkin lymphoma that primarily affects the skin. Globally, millions suffer from CTCL, and in Europe, the annual incidence is estimated at 2.9 to 3.9 cases per million people ( https://ibn.fm/ANk8X ). Despite its rarity, CTCL presents a substantial unmet medical need, particularly in early-stage patients who often have limited treatment options. Addressing this gap, Soligenix (NASDAQ: SNGX) recently announced the expansion of its European Medical Advisory Board (“MAB”) ( https://ibn.fm/6354Y ) to provide additional clinical and strategic guidance as the company advances its confirmatory phase 3 study (referred to as FLASH2) evaluating the safety and efficacy of its proprietary CTCL treatment: HyBryte(TM).