Soligenix Inc. Announces Key Clinical and Strategic Milestones in Rare Disease Treatment Development

Soligenix Inc. (NASDAQ: SNGX), a biopharmaceutical company focused on rare diseases, has provided a shareholder update highlighting critical clinical and strategic milestones. The update, delivered by Dr. Christopher J. Schaber, President and CEO, underscores the anticipated Phase 3 FLASH 2 results for HyBryte(TM), a promising treatment for cutaneous T-cell lymphoma, expected in the second half of 2026. This development is pivotal for patients and the medical community, offering hope for a condition with limited treatment options.

Further advancements include updates on Soligenix's psoriasis (SGX302) and Behçet’s Disease (SGX945) treatments, slated for the third and fourth quarters of 2025. An investigator-initiated study has already demonstrated a 75% success rate at 18 weeks, signaling the potential efficacy of Soligenix's pipeline. The company projects that HyBryte(TM) could reach peak U.S. annual sales of over $90 million, with the broader pipeline presenting global opportunities exceeding $2 billion.

With approximately $7 million in cash, Soligenix is actively seeking partnerships and mergers and acquisitions to bolster its financial position into the first quarter of 2026. This strategic maneuvering is essential for supporting global regulatory filings and the eventual commercialization of its treatments. The company's dedication to rare diseases, particularly those with unmet medical needs, is evident in its innovative approaches, including the use of synthetic hypericin and innate defense regulator technology.

The implications of Soligenix's announcements are far-reaching, not only for the biopharmaceutical industry but also for patients worldwide. The potential of HyBryte(TM) and other treatments in Soligenix's pipeline to address significant healthcare challenges cannot be overstated. For more information on Soligenix's developments, visit https://www.soligenix.com.