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Soligenix Inc. (NASDAQ: SNGX) Innovative Platform Provides Novel Treatment for Underserved CTCL Space

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

This development aligns with healthcare initiatives aimed at improving treatment access and accelerating medical innovation, particularly relevant as over 30 million Americans live with rare diseases. The company's focus on CTCL represents a strategic move to address an underserved therapeutic area, especially significant given the aging American population and the challenges in diagnosing rare diseases in seniors.

Soligenix (NASDAQ: SNGX) sta sviluppando la sua piattaforma HyBryte™ per rispondere alla crescente necessità di terapie per malattie rare, concentrandosi in particolare sul linfoma cutaneo a cellule T (CTCL), un raro tumore della pelle che colpisce principalmente gli anziani. L'azienda ha già avviato con successo la produzione negli Stati Uniti dell'ingrediente attivo di HyBryte.

Questo progresso è in linea con le iniziative sanitarie volte a migliorare l'accesso alle cure e a velocizzare l'innovazione medica, un aspetto particolarmente rilevante considerando che oltre 30 milioni di americani convivono con malattie rare. L'attenzione dell'azienda sul CTCL rappresenta una mossa strategica per affrontare un'area terapeutica poco servita, soprattutto in considerazione dell'invecchiamento della popolazione americana e delle difficoltà nella diagnosi delle malattie rare negli anziani.

Soligenix (NASDAQ: SNGX) está avanzando con su plataforma HyBryte™ para atender la creciente demanda de tratamientos para enfermedades raras, enfocándose específicamente en el linfoma cutáneo de células T (CTCL), un cáncer de piel poco común que afecta principalmente a adultos mayores. La compañía ha establecido con éxito la fabricación en Estados Unidos del ingrediente activo de HyBryte.

Este desarrollo se alinea con las iniciativas de salud destinadas a mejorar el acceso a tratamientos y acelerar la innovación médica, especialmente relevante dado que más de 30 millones de estadounidenses viven con enfermedades raras. El enfoque de la empresa en el CTCL representa un movimiento estratégico para abordar un área terapéutica desatendida, especialmente importante considerando el envejecimiento de la población estadounidense y los desafíos en el diagnóstico de enfermedades raras en personas mayores.

Soligenix (NASDAQ: SNGX)는 희귀 질환 치료제에 대한 증가하는 수요를 해결하기 위해 HyBryte™ 플랫폼을 발전시키고 있으며, 주로 노년층에게 영향을 미치는 희귀 피부암인 피부 T세포 림프종(CTCL)을 집중적으로 겨냥하고 있습니다. 회사는 HyBryte의 활성 성분에 대한 미국 내 제조를 성공적으로 구축했습니다.

이 개발은 치료 접근성 향상과 의료 혁신 가속화를 목표로 하는 보건 의료 이니셔티브와 일치하며, 특히 3천만 명 이상의 미국인이 희귀 질환을 앓고 있다는 점에서 중요합니다. 회사의 CTCL에 대한 집중은 고령화하는 미국 인구와 노년층에서 희귀 질환 진단의 어려움을 고려할 때, 치료가 부족한 분야를 전략적으로 공략하는 움직임입니다.

Soligenix (NASDAQ : SNGX) fait progresser sa plateforme HyBryte™ pour répondre au besoin croissant de traitements pour les maladies rares, en ciblant spécifiquement le lymphome cutané à cellules T (CTCL), un cancer de la peau rare qui touche principalement les personnes âgées. L'entreprise a réussi à établir la fabrication aux États-Unis de l'ingrédient actif de HyBryte.

Ce développement s'inscrit dans les initiatives de santé visant à améliorer l'accès aux traitements et à accélérer l'innovation médicale, particulièrement pertinent alors que plus de 30 millions d'Américains vivent avec des maladies rares. L'accent mis par l'entreprise sur le CTCL représente une démarche stratégique pour répondre à un domaine thérapeutique peu desservi, d'autant plus important compte tenu du vieillissement de la population américaine et des difficultés à diagnostiquer les maladies rares chez les personnes âgées.

Soligenix (NASDAQ: SNGX) treibt seine HyBryte™-Plattform voran, um dem wachsenden Bedarf an Behandlungen für seltene Krankheiten gerecht zu werden, wobei der Fokus speziell auf dem kutanen T-Zell-Lymphom (CTCL) liegt, einer seltenen Hautkrebserkrankung, die hauptsächlich ältere Erwachsene betrifft. Das Unternehmen hat erfolgreich die Herstellung des Wirkstoffs von HyBryte in den USA etabliert.

Diese Entwicklung steht im Einklang mit Gesundheitsinitiativen, die darauf abzielen, den Zugang zu Behandlungen zu verbessern und medizinische Innovationen zu beschleunigen – besonders relevant, da über 30 Millionen Amerikaner mit seltenen Krankheiten leben. Der Fokus des Unternehmens auf CTCL stellt einen strategischen Schritt dar, um ein unterversorgtes therapeutisches Gebiet anzugehen, was angesichts der alternden US-Bevölkerung und der Herausforderungen bei der Diagnose seltener Krankheiten bei Senioren von besonderer Bedeutung ist.

Positive
  • Successful establishment of U.S.-based manufacturing for HyBryte's active ingredient
  • Strategic positioning in underserved CTCL market with high growth potential
  • Alignment with government healthcare initiatives for rare disease treatments
Negative
  • Early stage of commercialization with no revenue generation yet
  • Operating in highly competitive pharmaceutical market

NEW YORK, Aug. 05, 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, “Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas,” please visit: https://nnw.fm/zFA5O

As America’s population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration’s “Make America Healthy Again” initiatives have emphasized improving access to treatments and accelerating medical innovation.

Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte’s active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population.

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 (SNGX) main product development focus?

Soligenix is developing the HyBryte™ platform, a novel therapy targeting cutaneous T-cell lymphoma (CTCL), a rare 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.

What market opportunity is Soligenix (SNGX) targeting with HyBryte?

Soligenix is targeting the rare disease market, specifically CTCL, which is part of a broader market where over 30 million Americans live with rare diseases.

How does Soligenix's (SNGX) HyBryte align with current healthcare initiatives?

HyBryte aligns with healthcare initiatives focused on improving treatment access and accelerating medical innovation for rare diseases, particularly supporting the 'Make America Healthy Again' objectives.

What patient population does Soligenix (SNGX) target with HyBryte?

HyBryte targets patients with cutaneous T-cell lymphoma (CTCL), primarily affecting older adults, addressing an underserved therapeutic area in the aging American population.
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