LOS ANGELES, CA - March 23, 2026 (NEWMEDIAWIRE) - Regulatory recognition from international health authorities can significantly shape the trajectory of emerging therapies worldwide, particularly in rare disease development where clinical pathways are often complex and resource intensive. Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases and unmet medical needs, recently received such recognition as its investigational therapy SGX945 was granted Promising Innovative Medicine (“PIM”) designation by the United Kingdom’s (“UK’s”) Medicines and Healthcare products Regulatory Agency (“MHRA”).

• Designations granted by leading global regulatory agencies play a critical role in advancing drug-development programs.
• The UK Medicines and Healthcare Products Regulatory Agency granted Promising Innovative Medicine designation to Soligenix’s SGX945 (dusquetide) for the treatment of Behçet’s disease.
• The recent designation in the United Kingdom builds on other regulatory recognitions previously granted to dusquetide.

Designations granted by leading regulatory agencies play a critical role in advancing drug-development programs. These recognitions often signal that a therapy shows potential to address serious conditions where few treatment options exist. According to the UK MHRA, the PIM designation is awarded to…

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Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law

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