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Soligenix Inc. (NASDAQ: SNGX) Proprietary Platform Aims to Meet Growing Need for Effective CTCL Therapy

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Soligenix (NASDAQ: SNGX) is advancing its HyBryte™ platform to address the growing need for effective treatments in cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer primarily affecting older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient.

The development comes amid increasing healthcare challenges related to rare diseases, which affect over 30 million Americans. The initiative aligns with the "Make America Healthy Again" program, which aims to improve treatment access and accelerate medical innovation, particularly for an aging population facing complex healthcare needs and often experiencing diagnostic delays.

Soligenix (NASDAQ: SNGX) sta sviluppando la sua piattaforma HyBryte™ per rispondere alla crescente necessità di trattamenti efficaci per il linfoma cutaneo a cellule T (CTCL), una rara forma di cancro della pelle che colpisce principalmente gli anziani. L'azienda ha stabilito con successo una produzione negli Stati Uniti per il principio attivo di HyBryte.

Questo sviluppo avviene in un contesto di crescenti sfide sanitarie legate alle malattie rare, che interessano oltre 30 milioni di americani. L'iniziativa è in linea con il programma "Make America Healthy Again", che mira a migliorare l'accesso alle terapie e ad accelerare l'innovazione medica, soprattutto per una popolazione anziana che affronta bisogni sanitari complessi e spesso ritardi diagnostici.

Soligenix (NASDAQ: SNGX) está avanzando con su plataforma HyBryte™ para abordar la creciente necesidad de tratamientos efectivos para el linfoma cutáneo de células T (CTCL), una forma rara de cáncer de piel que afecta principalmente a adultos mayores. La compañía ha establecido con éxito la fabricación en EE.UU. del ingrediente activo de HyBryte.

Este desarrollo surge en medio de crecientes desafíos en la atención médica relacionados con enfermedades raras, que afectan a más de 30 millones de estadounidenses. La iniciativa está alineada con el programa "Make America Healthy Again", que busca mejorar el acceso a tratamientos y acelerar la innovación médica, especialmente para una población envejecida que enfrenta necesidades sanitarias complejas y frecuentes retrasos en el diagnóstico.

Soligenix (NASDAQ: SNGX)는 희귀 피부암인 피부 T세포 림프종(CTCL)에 효과적인 치료법에 대한 증가하는 수요를 해결하기 위해 HyBryte™ 플랫폼을 발전시키고 있습니다. 이 질환은 주로 노년층에 영향을 미칩니다. 회사는 HyBryte의 활성 성분에 대해 미국 내 제조를 성공적으로 구축하였습니다.

이번 개발은 3천만 명이 넘는 미국인이 영향을 받는 희귀질환과 관련된 보건의료 문제 증가 속에서 이루어졌습니다. 이 이니셔티브는 "Make America Healthy Again" 프로그램과 일치하며, 이 프로그램은 치료 접근성을 개선하고 의료 혁신을 가속화하는 것을 목표로 합니다. 특히 복잡한 의료 요구와 진단 지연을 자주 겪는 고령 인구를 위한 것입니다.

Soligenix (NASDAQ : SNGX) fait progresser sa plateforme HyBryte™ pour répondre au besoin croissant de traitements efficaces contre le lymphome cutané à cellules T (CTCL), une forme rare de cancer de la peau touchant principalement les personnes âgées. L'entreprise a réussi à établir une fabrication basée aux États-Unis pour l'ingrédient actif de HyBryte.

Ce développement intervient dans un contexte de défis sanitaires croissants liés aux maladies rares, qui touchent plus de 30 millions d'Américains. L'initiative s'inscrit dans le cadre du programme "Make America Healthy Again", qui vise à améliorer l'accès aux traitements et à accélérer l'innovation médicale, en particulier pour une population vieillissante confrontée à des besoins de santé complexes et souvent à des retards de diagnostic.

Soligenix (NASDAQ: SNGX) entwickelt seine HyBryte™-Plattform weiter, um dem wachsenden Bedarf an wirksamen Behandlungen für das kutane T-Zell-Lymphom (CTCL) gerecht zu werden, eine seltene Form von Hautkrebs, die hauptsächlich ältere Erwachsene betrifft. Das Unternehmen hat erfolgreich eine US-amerikanische Produktion für den Wirkstoff von HyBryte etabliert.

Diese Entwicklung erfolgt vor dem Hintergrund zunehmender Herausforderungen im Gesundheitswesen im Zusammenhang mit seltenen Krankheiten, die über 30 Millionen Amerikaner betreffen. Die Initiative steht im Einklang mit dem Programm "Make America Healthy Again", das darauf abzielt, den Zugang zu Behandlungen zu verbessern und medizinische Innovationen zu beschleunigen, insbesondere für eine alternde Bevölkerung mit komplexen Gesundheitsbedürfnissen und häufigen Diagnoseverzögerungen.

Positive
  • Successful establishment of U.S.-based manufacturing for HyBryte's active ingredient
  • Addressing large market opportunity with over 30 million Americans affected by rare diseases
  • Strategic alignment with government healthcare initiatives
Negative
  • No FDA approval yet for HyBryte platform
  • Potential delays in diagnostic processes could affect market penetration

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ 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.

To view the full publication, “Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators,” please visit: https://nnw.fm/QCrhc .

As the American population gets older, chronic and rare diseases are becoming a significant healthcare issue, particularly for older adults. The aging population's increasing life expectancy also leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years. There are more than 30 million Americans who have a rare disease, so there is a growing need for accurate diagnoses and effective treatments.

The Trump administration's "Make America Healthy Again" initiatives have highlighted this problem and focused on improving access to treatments and speeding up medical innovation. Soligenix Inc. (NASDAQ: SNGX) is working to advance this mission with its HyBryte(TM) platform, a new therapy for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer that largely impacts older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient, demonstrating the kind of domestic innovation that can significantly help this underserved patient group. 

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

About NetworkNewsWire

NetworkNewsWire (“NNW”) is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge.

For more information, please visit https://www.NetworkNewsWire.com

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FAQ

What is Soligenix's (NASDAQ: SNGX) main product development focus?

Soligenix is developing the HyBryte™ platform, a new therapy for cutaneous T-cell lymphoma (CTCL), which is a rare form of skin cancer primarily affecting older adults.

Where is Soligenix (SNGX) manufacturing HyBryte's active ingredient?

Soligenix has established U.S.-based manufacturing for HyBryte's active ingredient, supporting domestic medical innovation.

How many Americans are affected by rare diseases according to Soligenix's press release?

Over 30 million Americans are affected by rare diseases, highlighting the significant market need for innovative treatments.

What healthcare initiative is Soligenix's CTCL therapy aligned with?

The development aligns with the 'Make America Healthy Again' initiatives, which focus on improving treatment access and accelerating medical innovation.

What patient population does Soligenix's HyBryte target?

HyBryte targets patients with cutaneous T-cell lymphoma (CTCL), particularly focusing on older adults who are more commonly affected by this rare form of skin cancer.
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