- Soligenix revealed updates to its U.S. Medical Advisory Board for CTCL designed to support the clinical advancement of HyBryte(TM) (synthetic hypericin) and related therapies.
- These changes are timely given the complexities of CTCL and the evolving therapeutic landscape.
- The company’s decision to refresh its CTCL advisory team reflects a recognition that commercialization preparation in the CTCL space, evolving regulatory expectations and the need for robust trial designs demand expert insight.
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.
Soligenix revealed updates to its U.S. Medical Advisory Board for CTCL designed to support the clinical advancement of HyBryte (synthetic hypericin) and related therapies; specifically, the updates include the addition of new members and the retirement of prior advisors. The company noted that the updated board reflects growing scientific insight into CTCL treatment pathways and is intended to enhance the translational and clinical strategic guidance for HyBryte’s potential regulatory and commercial trajectory.
“We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board,” said Soligenix president and CEO Christopher J. Schaber. “Many of the MAB members have experience treating patients with HyBryte and have been invaluable to the program. We are excited to continue to work with them to facilitate the advancement of HyBryte to commercialization worldwide.” According to the company, the newly configured advisory board will provide counsel on pivotal trial design, regulatory engagement and potential strategic partnerships in CTCL.
These changes are timely given the complexities of CTCL and the evolving therapeutic landscape. CTCL is a rare form of non-Hodgkin lymphoma that primarily affects the skin and is characterized by malignant T-cells residing in the skin for prolonged periods. The condition can progress from patches and plaques to tumors, and in advanced stages may involve lymph nodes or internal organs.
According to the Lymphoma Research Foundation, around 3,000 new cases of CTCL are diagnosed in the U.S. annually, and the disease remains incurable (https://ibn.fm/op83a). Treatment options include skin-directed therapies, systemic agents, biologics and recently approved targeted therapies, but unmet needs persist, especially for relapsed or refractory disease and in patients who progress despite available options. The highly heterogeneous nature of CTCL and its variable course make clinical development particularly challenging.
In that context, the role of a strong and relevant Medical Advisory Board becomes crucial. Soligenix’s decision to refresh its CTCL advisory team reflects a recognition that commercialization preparation in the CTCL space, evolving regulatory expectations and the need for robust trial designs demand expert insight. The updated advisory board is expected to advise on patient population definitions, endpoint selection, dose optimization, long-term follow-up strategies and potential label positioning. For HyBryte, which has already demonstrated positive results in its first Phase 3 clinical trial, having an advisory board closely aligned with specialist clinicians and thought leaders may accelerate registration pathways, refine patient-selection strategies and support market-access planning.
Moreover, the timing aligns with Soligenix’s broader pipeline strategy. The company has noted that HyBryte is a lead value driver, with its next expected inflection points including data read-out and regulatory engagement in the 2025–2026 timeframe (https://ibn.fm/84p9u). By updating its advisory board now, Soligenix is aligning its governance and clinical strategy ahead of those anticipated milestones, positioning itself for disciplined execution and clearer regulatory dialogue.
Experts in CTCL treatment emphasize the importance of strategic collaborations and advisory input in rare-disease trials. Given the low incidence of CTCL and diversity of disease presentation, engaging a board with recognized clinical experience in cutaneous lymphoma, dermatology-oncology interplay and regulatory mindset can enhance trial recruitment, endpoint relevance and payer discussions post approval. Soligenix’s updated board may also contribute insight into combinatorial strategies, development of biomarker-driven patient subgroups and incorporation of patient-reported outcomes, all of which are increasingly emphasized by regulatory authorities and payers in rare-disease drug development.
From an investor vantage point, this advisory board update signals that Soligenix is not only advancing its HyBryte therapy but also refining the infrastructure around it, an often underrated aspect of clinical-stage biotech execution. With an extended cash runway, thanks in part to a recent $7.5 million public offering (https://ibn.fm/QKXcv) and a refreshed advisory board guiding its CTCL strategy, the company looks to be better positioned as it moves forward.
The company’s update to its U.S. Medical Advisory Board for CTCL reflects strategic alignment with the complex and evolving CTCL therapeutic landscape. With HyBryte as a core value driver and a clinical development timetable that points into 2026, the company is actively preparing the frameworks, both scientific and regulatory, for advancement and potential commercialization. As CTCL remains an area of considerable unmet need, Soligenix’s refreshed advisory board may serve as a differentiator in successfully navigating that terrain.
For more information, visit 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
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