Soligenix Receives Orphan Drug Designation from the European Commission for SGX945 for the Treatment of Behçet's Disease

Rhea-AI Summary

Soligenix (Nasdaq: SNGX) announced the European Commission granted orphan drug designation to dusquetide (active in SGX945) for the treatment of Behçet's Disease on March 26, 2026. The decision followed a positive EMA COMP recommendation and Phase 2a results showing biological efficacy and safety.

The designation complements prior FDA orphan and fast track statuses, offers a 10-year EU marketing exclusivity after approval, and provides protocol assistance and centralized authorization access for development.

Positive

• EMA orphan designation for dusquetide provides 10-year EU exclusivity after approval
• Phase 2a results demonstrated biological efficacy and safety in Behçet's Disease patients
• Prior FDA orphan and fast track designations already granted for SGX945
• Access to EMA protocol assistance and centralized authorization can accelerate EU development

Negative

• None.

News Market Reaction – SNGX

+0.83% 22.9x vol

22 alerts

+0.83% Session close to close

+10.9% Peak Tracked

-22.5% Trough Tracked

$12.20M Market Cap

22.9x Rel. Volume

In the Mar 26 session, SNGX gained 0.83%, reflecting a mild positive market reaction. Argus tracked a peak move of +10.9% during that session. Argus tracked a trough of -22.5% from its starting point during tracking. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. Trading volume was exceptionally heavy at 22.9x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds European Commission orphan drug designation for SGX945 to prior EMA and FDA d...

Analysis

This announcement adds European Commission orphan drug designation for SGX945 to prior EMA and FDA designations, reinforcing regulatory momentum in Behçet's Disease. Orphan status brings 10 years of EU marketing exclusivity, protocol assistance, and centralized review, building on Phase 2a efficacy and safety data. Historically, Soligenix’s clinical updates have produced volatile and sometimes divergent price reactions, so tracking future trial design, regulatory interactions, and funding disclosures will be important for assessing how this program advances.

Key Figures

EU marketing exclusivity: 10 years Prevalence threshold EU: 5 in 10,000 persons U.S. Behçet's prevalence: 18,000 people +3 more

6 metrics

EU marketing exclusivity 10 years EMA orphan drug designation exclusivity period after approval

Prevalence threshold EU 5 in 10,000 persons Condition prevalence limit for EU orphan designation

U.S. Behçet's prevalence 18,000 people Estimated number of affected individuals in the U.S.

Europe Behçet's prevalence 50,000 people Estimated number of affected individuals in Europe

Turkey Behçet's prevalence 350,000 people Estimated number of affected individuals in Turkey

Global Behçet's prevalence 1,000,000 people Estimated number of affected individuals worldwide

Previous Clinical trial Reports

5 past events · Latest: Feb 26 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 26	EMA orphan opinion	Positive	-2.5%	EMA COMP issued positive opinion on SGX945 orphan request for Behçet's.
Dec 18	Phase 2 results	Positive	+0.0%	Phase 2a SGX945 data in Behçet's published showing efficacy and safety.
Nov 19	HyBryte Phase 3	Positive	-3.6%	HyBryte FLASH2 interim enrollment milestone and favorable blinded response rate.
Oct 07	HyBryte safety update	Positive	+19.7%	DMC found no safety concerns in HyBryte FLASH2 Phase 3 study.
Jul 31	SGX945 Phase 2a	Positive	+134.4%	SGX945 Phase 2a showed biological efficacy and no treatment‑related AEs.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical and regulatory milestones have often been positive, but price reactions were mixed, ranging from modest declines to a 134.4% spike on strong SGX945 Phase 2 data.

Recent Company History

Over the past year, Soligenix has reported multiple clinical milestones in CTCL and Behçet's Disease. Key events include positive Phase 2a SGX945 results (news_id 886038), HyBryte Phase 3 safety and enrollment updates, and an EMA COMP positive opinion on SGX945 orphan status (news_id 1019136). Price reactions have varied, with declines after some positive HyBryte and EMA updates but strong gains on early SGX945 efficacy data. Today’s European Commission orphan designation extends this SGX945 regulatory trajectory in Behçet's Disease.

Key Terms

orphan drug designation, european medicines agency, committee for orphan medicinal products, fast track, +4 more

8 terms

orphan drug designation regulatory

"has granted orphan drug designation to dusquetide (the active pharmaceutical"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

european medicines agency regulatory

"recommendation from the European Medicines Agency (EMA) Committee for Orphan"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

committee for orphan medicinal products regulatory

"European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP)"

A Committee for Orphan Medicinal Products is a regulatory expert panel that assesses whether a drug or therapy qualifies for special status because it treats a rare disease. Earning that designation typically brings incentives such as reduced fees, protocol support and a period of market protection, so investors watch these decisions as a signal that a treatment may face less competition and have stronger commercial and regulatory advantages—like gaining a protected license.

fast track regulatory

"has previously been granted both orphan drug and fast track designations"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

u.s. food and drug administration regulatory

"designations from the U.S. Food and Drug Administration (FDA) for the treatment"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

marketing exclusivity regulatory

"provides a 10-year period of marketing exclusivity in the European Union"

A limited regulatory right that prevents competing versions of a drug or product from being approved for sale for a set period, even if patents don't block them. For investors, it creates a temporary window of reduced competition and steadier revenue—like being the only bakery allowed to sell a popular recipe for a season—so the size and length of exclusivity can significantly affect future sales and valuation.

centralized authorization procedure regulatory

"development phase, and direct access to the centralized authorization procedure."

A centralized authorization procedure is a single regulatory review that grants approval for a medicine or medical product across an entire regulatory region at once, rather than requiring separate approvals in each country. Like getting one passport that lets you enter many countries instead of many visas, it speeds market access, creates a single clear regulatory outcome, and reduces the uncertainty and cost of launching products—factors that directly affect sales forecasts, time to revenue, and investment risk.

protocol assistance regulatory

"provides incentives for companies seeking protocol assistance from the EMA"

Protocol assistance is formal guidance from regulators or experts on how to design and run a clinical trial or study to meet safety and approval requirements. For investors, it matters because clear, authoritative guidance lowers the chance of costly delays or rejected data—like getting a building inspector’s checklist before construction, it helps sponsors avoid mistakes and increases the likelihood that trial results will be accepted by authorities.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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PRINCETON, N.J., March 26, 2026 /PRNewswire/ --Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet's Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease. SGX945 has previously been granted both orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA) for the treatment of Behçet's Disease.

Orphan drug designation by the EMA provides a 10-year period of marketing exclusivity in the European Union (EU) after product approval. Orphan designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure. The European Commission grants orphan designations for medicines that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU and where no satisfactory treatment is available.

"We are extremely pleased to have received European orphan drug designation for the SGX945 program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Behçet's Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 people in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease. Given the clinically meaningful improvements seen in our Phase 2 proof-of-concept study in patients with oral aphthous ulcers due to Behçet's Disease, we are hopeful dusquetide will have a role to play in helping underserved patients suffering from this difficult to treat and chronic auto-immune disease. The European Commission's decision to grant orphan drug designation to the SGX945 program signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing intellectual property estate surrounding this novel technology."

About Dusquetide

Dusquetide, the active ingredient in SGX945 (Behçet's Disease) and SGX942 (oral mucositis), is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective, and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of Gram-negative and Gram-positive bacterial pathogens. Dusquetide also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, and chemo- and/or radiation therapy. Preclinical efficacy and safety have been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome as well as bacterial infections. In addition, potential anti-tumor activity has been demonstrated in multiple in vitro and in vivo xenograft studies.

Dusquetide has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits.

Dusquetide has also demonstrated biological efficacy and safety in a Phase 2a pilot study in 8 patients with Behçet's Disease. The Phase 2a study was an open-label study designed to be highly comparable (e.g., study endpoints, inclusion-exclusion criteria) to the published Phase 3 study which was used to support marketing approval of apremilast (Otezla^®) for oral ulcers in Behçet's disease. The primary endpoint in the Phase 3 apremilast study was the area under the curve (AUC) of the mean number of ulcers versus time.  Using this same endpoint after 4 weeks of treatment, the SGX945 treated group had a 40% improvement relative to the placebo group from the Phase 3 apremilast study, whereas apremilast had a 37% improvement relative to placebo. This improvement was sustained throughout the 4-week follow-up after treatment with SGX945, with 32% improvement evaluated at Week 8 despite treatment having stopped at Week 4. In contrast, apremilast, which was continuously administered through Week 12, had a 41% improvement at Week 8. One patient began the study with a punctuated skin ulcer and this also resolved during the 4-week treatment with SGX945. Skin ulcers are generally considered very difficult to resolve and usually require protracted treatment. Notably, some patients also explicitly reported experiencing fewer ulcers and less pain during the 4-week follow-up period, as also reflected in the numerical analysis. SGX945 was well-tolerated with no treatment-related adverse events. Common adverse events for apremilast included diarrhea (41% of patients), nausea (19% of patients) and headache (14% of patients), none of which were observed with SGX945.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Dusquetide has been awarded Fast-Track designation for the treatment of oral lesions of Behçet's Disease and Orphan Drug designation for the treatment of Behçet's Disease by the FDA and EMA as well as Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) from the Medicines and Healthcare Products Regulatory Agency (MHRA).

About Behçet's Disease

Behçet's Disease is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores (approximately 50% of patients), leg ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of patients). It is a painful disease, directly impacting the patient's quality of life and ability to productively engage in life activities, including work.

Behçet's Disease is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the "Silk Road" in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are approximately 18,000 known cases of Behçet's Disease in the U.S. and over 50,000 in Europe. There are as many as 1,000,000 people worldwide living with Behçet's Disease.

There is no cure for Behçet's Disease, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post-thrombotic syndrome. Other treatments for Behçet's Disease flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in Behçet's Disease is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast must be used continuously to be effective and is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax^®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.

This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma or any other studies (including the open-label, investigator-initiated study) and the overall blinded aggregate response rate observed in the second HyBryte™ (SGX301) Phase 3 clinical trial, there can be no assurance that the second HyBryte™ (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte™ (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Additionally, despite the biologic activity observed in aphthous ulcers induced by chemotherapy and radiation, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax^® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax^®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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SOURCE SOLIGENIX, INC.

FAQ

What does the EMA orphan drug designation mean for Soligenix (SNGX) and SGX945?

It grants potential 10-year marketing exclusivity in the EU after approval, protecting the product from similar approvals. According to Soligenix, the designation also enables protocol assistance and centralized authorization access to support EU development.

Why did the European Commission grant orphan status to SGX945 (SNGX) on March 26, 2026?

Because SGX945 treats Behçet's Disease, a rare, serious condition meeting EMA criteria of ≤5 in 10,000 people. According to Soligenix, the decision followed a positive EMA COMP recommendation and Phase 2a efficacy and safety data.

How do Phase 2a results affect the SGX945 program for Soligenix (SNGX)?

Phase 2a demonstrated biological efficacy and a tolerable safety profile in patients with Behçet's Disease, supporting further development. According to Soligenix, these results underpinned the EMA COMP recommendation for orphan designation.

Does the EMA orphan designation for SGX945 change Soligenix's (SNGX) regulatory pathway in the EU?

Yes — it provides direct access to the EMA centralized authorization procedure and protocol assistance, potentially streamlining EU approval. According to Soligenix, these incentives aim to facilitate clinical development and regulatory interactions.

What prior U.S. regulatory designations does SGX945 hold for Behçet's Disease (SNGX)?

SGX945 has previously received both orphan drug and fast track designations from the FDA for Behçet's Disease. According to Soligenix, these U.S. designations complement the new European orphan status and support development.