Soligenix Expands European Medical Advisory Board to Advance Cutaneous T-Cell Lymphoma Treatment

Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on rare disease treatments, has expanded its European Medical Advisory Board to guide the confirmatory Phase 3 trial of HyBryte(TM) in early-stage cutaneous T-cell lymphoma. The 18-week study is enrolling approximately 80 patients, with top-line results expected in the second half of 2026, as the company strengthens European engagement ahead of potential commercialization.

The expansion of the European Medical Advisory Board represents a strategic move to ensure regional expertise guides the clinical development of HyBryte, which could become an important treatment option for patients suffering from cutaneous T-cell lymphoma. This rare disease currently has limited treatment options, particularly those that utilize safe visible light technology like HyBryte's novel photodynamic therapy approach. The full press release detailing this development can be viewed at https://ibn.fm/b9dsR.

HyBryte (SGX301 or synthetic hypericin sodium) represents a significant advancement in photodynamic therapy, utilizing safe visible light rather than more damaging ultraviolet light typically used in such treatments. This distinction is particularly important for patients with cutaneous T-cell lymphoma who often require repeated treatments over time, making safety profiles a critical consideration. The successful completion of this second Phase 3 study will support regulatory approvals for potential commercialization worldwide, addressing a substantial unmet medical need in the rare disease space.

The implications of this expanded European engagement extend beyond the immediate clinical trial. By strengthening its European medical advisory presence, Soligenix is positioning itself for smoother regulatory pathways and potential market adoption across European healthcare systems. This strategic move acknowledges the importance of regional medical expertise in navigating complex regulatory environments and establishing treatment protocols that align with European standards of care. Investors and stakeholders can access the latest news and updates relating to SNGX through the company's newsroom at https://ibn.fm/SNGX.

For the pharmaceutical industry, Soligenix's approach demonstrates the importance of regional engagement strategies in global drug development. The expansion of medical advisory boards in key markets prior to potential commercialization reflects a growing trend of early stakeholder engagement in the biopharmaceutical sector. This proactive approach can facilitate smoother regulatory reviews and faster adoption by healthcare providers once treatments receive approval. The development also highlights the continued investment in rare disease treatments, an area that has seen increased focus due to orphan drug designations and regulatory incentives.

The timing of this expansion is particularly significant given the expected 2026 timeline for top-line results. By establishing strong European medical advisory relationships now, Soligenix ensures that regional expertise will inform both the final stages of clinical development and potential commercialization strategies. This forward-looking approach could potentially accelerate patient access to new treatments if regulatory approvals are secured, benefiting both the company and patients suffering from this rare form of lymphoma.