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).
- Cutaneous T-cell lymphoma (CTCL) is a rare subtype of non-Hodgkin’s lymphoma that disproportionately affects older adults.
- SNGX’s confirmatory FLASH2 study represents the final major step toward potential worldwide marketing approval for HyBryte.
- The first FLASH phase 3 trial demonstrated statistically significant efficacy, establishing a strong foundation for the confirmatory FLASH2 study.
- An ongoing investigator-initiated study at the University of Pennsylvania is providing additional real-world insight into HyBryte’s effectiveness.
- Beyond its immediate CTCL application, HyBryte’s life-cycle management strategy includes opportunities to expand the treatment’s reach and value.
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A Diagnostic Challenge Meets Policy Change
Rare diseases have long been difficult to diagnose, but older adults often face a uniquely complex path. Many rare disease symptoms overlap with common age-related conditions such as dermatologic changes, cognitive decline, chronic inflammation or fatigue, making misdiagnosis a persistent problem. According to the National Organization for Rare Disorders (NORD), patients often go five to seven years before receiving an accurate diagnosis. This diagnostic delay can worsen outcomes, delay treatment, and create emotional and financial stress, particularly for older adults who frequently see multiple specialists without definitive answers.
Symptoms of rare diseases can also mimic those associated with normal aging. For example, skin changes that may appear benign can mask early manifestations of CTCL. Neurological or systemic symptoms related to rare autoimmune or genetic disorders may be mistaken for more common issues such as arthritis or dementia. This overlap complicates clinical assessments and often forces physicians to rely on advanced testing or second opinions to reach a conclusive diagnosis.
At the federal level, healthcare policy is shifting to address broader chronic disease burdens. The Trump administration’s Make America Healthy Again initiative emphasizes early detection, chronic disease management and improved access to innovative treatments. The White House initiative also notes goals to enhance affordability, improve care coordination and accelerate pathways for advanced therapies.
Soligenix has advanced several initiatives aligned with these national priorities. The company has successfully transferred manufacturing of HyBryte’s active ingredient to the United States, supporting supply chain resilience. In addition, the company is currently conducting FLASH2, a confirmatory phase 3 replication study of HyBryte for CTCL. This study builds on the previously statistically significant FLASH study, a successful comparative study, and supports investigator-initiated research, forming a robust dataset that shapes expectations for FLASH2 outcomes.
CTCL and the Growing Burden in Older Adults
Cutaneous T-cell lymphoma, or CTCL, is a rare subtype of non-Hodgkin’s lymphoma that disproportionately affects older adults. It develops when malignant T-cells migrate to the skin, forming patches, plaques, or tumors that progressively spread or intensify. CTCL is chronic, incurable and often misdiagnosed in early stages because symptoms resemble eczema, psoriasis, or other common dermatologic conditions associated with aging.
According to epidemiological estimates, CTCL affects more than 40,000 non-Hodgkin’s lymphoma patients worldwide and remains a significant challenge for clinicians. The global market for CTCL therapies is estimated at more than $250 million, with approximately $90 million attributable to the United States. Despite this market size, treatment options remain extremely limited. There is currently no approved first-line therapy for early-stage CTCL (stage I–IIA), which accounts for roughly 90% of all cases. Patients rely on off-label therapies, phototherapy regimens or immune-modulating agents, many of which carry substantial risks or limited long-term efficacy.
Mycosis fungoides is the most common subtype, making up the vast majority of CTCL cases. While early-stage disease has an estimated five-year survival rate of 88%, it remains a difficult-to-manage chronic cancer that can progress unpredictably. Current therapies often require many months before showing statistically significant improvement.
HyBryte offers an alternative mechanism of action designed specifically for early-stage CTCL and is positioned to address this unmet need. If approved, HyBryte could become the first available front-line therapy for early-stage disease, based on its targeted photodynamic mechanism using synthetic hypericin activated by fluorescent light. This treatment concept is differentiated not only by efficacy demonstrated in clinical studies but also by its potential safety advantages compared to ultraviolet-based phototherapy or systemic agents.
FLASH2 and Global Regulatory Progress
The confirmatory FLASH2 study represents the final major step toward potential worldwide marketing approval for HyBryte. The European Medicines Agency accepted the study design, which mirrors the first FLASH trial but includes an expanded 18-week double-blind, placebo-controlled treatment period. This design adjustment reflects both regulatory feedback and evidence generated through comparative and investigator-initiated studies that support longer-term HyBryte treatment intervals.
FLASH2 is expected to enroll approximately 80 patients, with data generation aligned with international regulatory standards. The inclusion and exclusion criteria, as well as the primary endpoint, remain consistent with the first FLASH study, enabling clean comparison and regulatory continuity. Enrollment is reported to be progressing on schedule. With approximately 50 patients already enrolled in the study as of November 18, an interim analysis is expected in the second quarter of 2026 and top-line results anticipated in the second half of 2026.
FLASH2 carries significant weight because the first phase 3 study delivered clear efficacy and safety results. These findings, combined with orphan drug designations in the U.S. and EU plus fast-track status from the FDA, position HyBryte as a highly advanced candidate within the regulatory pipeline.
FDA discussions for U.S. approval remain ongoing, with Soligenix emphasizing that FLASH2 is designed to satisfy remaining requirements for a global submission package. If results replicate or exceed FLASH outcomes, the company will be well positioned to pursue marketing applications in multiple regions. The global rare disease market values mature phase 3 programs with validated endpoints, especially in areas where there is no approved first-line therapy. HyBryte fits squarely into this category.
Given the chronic nature of CTCL and the lack of curative options, global regulators have historically supported treatments that demonstrate safety, durability, and quality-of-life improvement. HyBryte’s design matches these priorities by offering targeted, localized therapy with minimal systemic exposure. If FLASH2 succeeds, HyBryte could become a foundational CTCL treatment option worldwide.
Strong Phase 3 Results, Treatment Advantages
The first FLASH phase 3 trial demonstrated statistically significant efficacy, establishing a strong foundation for the confirmatory FLASH2 study. The results showed that HyBryte produced positive responses as early as six weeks and improved over time, reaching 40% at 12 weeks and 49% at 18 weeks. These results contrast sharply with many existing therapies, which often require 12 months or longer before achieving statistically significant improvement.
HyBryte has also demonstrated efficacy against both patch and plaque lesions. This is important because many early-stage CTCL therapies show activity primarily against patches, leaving deeper plaques under-treated, while plaque lesions are considered potential indicators of disease progression. The versatility of HyBryte’s response profile enhances its potential across a broader set of CTCL presentations, addressing a known treatment gap in dermatologic oncology.
Safety is one of HyBryte’s most compelling attributes. Across multiple clinical studies, HyBryte has been well tolerated with minimal adverse events. Unlike ultraviolet (UV) phototherapy, which can increase the risk of melanoma, other skin cancers and premature skin aging, HyBryte uses safe visible light and a nonmutagenic compound. There is no evidence of DNA damage, systemic toxicity or cumulative carcinogenic risk associated with the treatment.
Current CTCL therapies often come with serious risks, including immune suppression, secondary malignancies and severe dermatologic toxicity. Because CTCL is chronic and requires lifelong management, the safety profile of any therapy is a critical consideration for clinicians. HyBryte’s profile positions it as a potentially transformational therapy that provides durable improvement without compromising long-term patient safety.
The commercial potential reflects these advantages. With an estimated worldwide market value exceeding $250 million, HyBryte could meet unmet medical need in a space that has lacked innovation for years. If FLASH2 confirms the earlier results, HyBryte may emerge as a first-line treatment with global reach.
Investigator Study Shows 75% Response
An ongoing investigator-initiated study at the University of Pennsylvania is providing additional real-world insight into HyBryte’s effectiveness. The study administers HyBryte twice weekly for up to one year, allowing researchers to observe both extended treatment response and durability of effect. Importantly, the study’s 18-week data, which corresponds to the same time window used in the FLASH2 primary endpoint, show a 75% treatment response rate.
The significance of these findings is two-fold. First, they validate the treatment window selected for FLASH2, reinforcing the expectation that extended dosing yields stronger results. Second, they provide evidence from an independent academic center, adding scientific credibility to the program and confirming that HyBryte’s efficacy is reproducible outside a controlled phase 3 trial environment.
Investigator-initiated research is often a key driver of adoption in rare dermatologic diseases. Studies conducted in academic settings allow clinicians to evaluate treatment protocols, understand patient responses across diverse presentations, and refine real-world use cases. HyBryte’s strong performance in this setting supports its viability as a front-line CTCL therapy, especially for early-stage patients managing chronic symptoms.
As data accumulates, physicians gain greater confidence in integrating new treatments into their clinical practice. The strong 18-week results reported by the University of Pennsylvania study also suggest that HyBryte could yield long-term benefit through sustained or continued therapy, a critical consideration for chronic CTCL management.
Because CTCL requires lifelong monitoring and repeated interventions, therapies that maintain efficacy without imposing cumulative toxicity are ideal. HyBryte’s emerging profile in academic studies aligns with this need and strengthens the case for its adoption following regulatory approval.
Life Cycle Potential and Strategic Positioning
Beyond its immediate CTCL application, HyBryte’s life-cycle management strategy includes opportunities to expand the treatment’s reach and value. One major focus is the potential transition to home-use dosing, which could allow eligible patients to self-administer treatment using portable light devices. This would significantly expand market penetration, reduce clinician workload and improve patient convenience, particularly for older adults who may face mobility challenges.
HyBryte’s mechanism of action also has potential relevance in dermatologic conditions beyond CTCL. Soligenix is evaluating opportunities to explore synthetic hypericin, the active ingredient in HyBryte, for indications such as mild-to-moderate psoriasis, another chronic inflammatory skin disease affecting millions worldwide. Photodynamic approaches are already widely used in dermatology, and HyBryte’s safety profile makes it a promising candidate for broader photoactivated therapies.
Tomas J. Philipson, PhD, a former acting chair of the White House Council of Economic Advisers and a senior advisor in the Trump administration, provides strategic guidance to Soligenix as it advances HyBryte’s regulatory and commercial strategy. His policy experience and expertise in healthcare economics are expected to support Soligenix’s efforts to navigate regulatory pathways and market access challenges.
HyBryte’s phase 3 program is significantly de-risked compared to most late-stage drug programs. It has already demonstrated statistically significant results in a prior phase 3 trial, replicated treatment response in a comparative study, delivered strong outcomes in an investigator-initiated study, and advanced safety data through multiple clinical investigations. The FLASH2 study represents the final clinical milestone required before global marketing applications, with top-line results expected in the second half of 2026.
With meaningful milestones approaching in the next 6–12 months, Soligenix is entering a pivotal period. A positive outcome in FLASH2 could dramatically increase valuations by positioning HyBryte as the first-line therapy for early-stage CTCL, a space with significant unmet need and substantial commercial potential. As rare diseases and chronic conditions in older adults receive increasing national policy attention, HyBryte is poised to become one of the most important dermatologic oncology innovations in years.
Global Biopharma Advances New Treatment Frontiers
Across the life sciences sector, major innovators continue to make meaningful progress in the development and approval of next-generation therapies. Breakthroughs in areas such as targeted oncology, cell therapy, and treatments for rare or underserved conditions are expanding the possibilities of modern medicine. These advancements underscore how scientific investment, clinical rigor and accelerated regulatory pathways are converging to bring new options to patients worldwide.
Pfizer Inc. (NYSE: PFE) has received U.S. Food and Drug Administration (FDA) approval for one of its treatments. The company, along with Astellas Pharma Inc., announced that the FDA has approved its PADCEV (R) (enfortumab vedotin-ejfv) treatment, a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda(R) or Keytruda QLEX(TM), as neoadjuvant treatment and then continued after cystectomy (surgery) as adjuvant treatment for adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. The approval of this perioperative (before and after surgery) treatment was based on results from the pivotal phase 3 EV-303 clinical trial.
Merck & Co Inc.
(NYSE: MRK) has entered into an agreement to receive funds managed by Blackstone Life Sciences for the development of sacituzumab tirumotecan (sac-TMT). Sac-TMT is an investigational antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers.
Bristol-Myers Squibb Co.
(NYSE: BMY) received approval from the European Commission (EC) for Breyanzi(R). A CD19-directed chimeric antigen receptor (CAR) T cell therapy, Breyanzi was approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor. Company officials called the approval an important step as the company continues to deliver on the promise of cell therapy for more eligible patients across Europe.
Insmed Inc.
(NASDAQ: INSM) announced that the EC has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis. The approval is for patients 12 years of age and older with two or more exacerbations in the prior 12 months. BRINSUPRI is a first-in-class therapy, offering the first and only approved treatment indicated for NCFB in the European Union. BRINSUPRI was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health.
As these therapies gain regulatory momentum and move into broader clinical use, they represent more than individual breakthroughs; they reflect a growing commitment to transforming patient care across complex and life-threatening diseases. Continued progress in precision medicines, advanced biologics and first-in-class treatments signals a future in which more patients can access earlier, safer and more effective therapeutic innovations.
For more information, visit Soligenix Profile
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