Soligenix Receives Positive Opinion from the European Medicines Agency on the Request for Orphan Drug Designation for SGX945 for the Treatment of Behçet's Disease

Rhea-AI Summary

Soligenix (Nasdaq: SNGX) announced the EMA Committee for Orphan Medicinal Products (COMP) gave a positive opinion on its request for orphan drug designation for dusquetide (SGX945) to treat Behçet's Disease, following Phase 2a results showing biological efficacy and safety. The opinion must be ratified by the European Commission.

SGX945 previously received FDA orphan drug and fast track designations. EMA orphan status would provide 10 years of EU marketing exclusivity after approval and access to centralized authorization and protocol assistance.

Positive

• COMP positive opinion on EMA orphan designation request
• Phase 2a results showed biological efficacy and safety
• 10-year EU exclusivity available after product approval
• Prior FDA orphan and fast track designations already granted

Negative

• EMA orphan designation not yet ratified by European Commission
• Orphan exclusivity only applies after approval, approval required
• Small eligible population (≤5 per 10,000 in EU) limits market size

Key Figures

Marketing exclusivity EU: 10 years Behçet’s prevalence US: 18,000 people Behçet’s prevalence Europe: 50,000 people +4 more

7 metrics

Marketing exclusivity EU 10 years Orphan drug designation EMA post-approval

Behçet’s prevalence US 18,000 people Estimated affected in the U.S.

Behçet’s prevalence Europe 50,000 people Estimated affected in Europe

Behçet’s prevalence Turkey 350,000 people Estimated affected in Turkey

Behçet’s worldwide 1,000,000 people Estimated affected worldwide

Phase Phase 2a SGX945 clinical trial demonstrating biological efficacy and safety

EU rarity threshold 5 in 10,000 persons Maximum prevalence for EU orphan designation

Market Reality Check

Price: $1.18 Vol: Volume 80,294 is below 20...

low vol

$1.18 Last Close

Volume Volume 80,294 is below 20-day average of 151,735 (relative volume 0.53x). low

Technical Price $1.18 is trading below 200-day MA of $1.76 and 81.06% below 52-week high.

Peers on Argus

SNGX was modestly positive pre-news (+2.61%). Peers were mixed: LPTX +238.84%, M...

SNGX was modestly positive pre-news (+2.61%). Peers were mixed: LPTX +238.84%, MBIO +7.29%, MBRX +4.03%, XTLB +6.43%, while SNSE fell -5.57%, suggesting stock-specific dynamics rather than a uniform biotech move.

Previous Clinical trial Reports

5 past events · Latest: Dec 18 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 18	Phase 2a results	Positive	+0.0%	Publication of positive Phase 2a SGX945 Behçet’s data showing sustained benefit.
Nov 19	Phase 3 enrollment	Positive	-3.6%	HyBryte FLASH2 interim-enrollment milestone and higher-than-expected blinded response.
Oct 07	Safety milestone	Positive	+19.7%	DMC review in FLASH2 confirming acceptable safety and supporting trial continuation.
Jul 31	Phase 2 efficacy	Positive	+134.4%	Positive Phase 2a SGX945 efficacy versus placebo and no treatment-related AEs.
Jun 06	Clinical Q&A	Positive	+4.9%	Highlighting HyBryte’s safety, tolerability and promise in CTCL clinical trials.

Pattern Detected

Clinical and trial-related updates have often led to sizable moves, with some positive announcements still seeing flat or negative next-day reactions.

Recent Company History

Over the past year, Soligenix has highlighted multiple clinical milestones across HyBryte™ and SGX945. Events include positive Phase 2a data for SGX945 in Behçet's Disease on Jul 31, 2025 (large positive reaction), safety and enrollment milestones in the HyBryte FLASH2 Phase 3 program on Oct 7 and Nov 19, 2025, and publication of SGX945 Phase 2a results on Dec 18, 2025. Today’s EMA orphan-drug positive opinion for SGX945 builds directly on those Behçet’s efficacy and safety results.

Historical Comparison

+31.1% avg move · Clinical-trial headlines for SNGX have produced an average next-day move of 31.07%. Today’s EMA orph...

clinical trial

+31.1%

Average Historical Move clinical trial

Clinical-trial headlines for SNGX have produced an average next-day move of 31.07%. Today’s EMA orphan opinion extends the SGX945 Behçet’s storyline built in prior Phase 2a updates.

Historical events show progression from early HyBryte™ Phase 3 safety/enrollment milestones and SGX945 Phase 2a efficacy to today’s regulatory recognition of SGX945 in Behçet’s Disease.

Market Pulse Summary

This announcement highlights a positive opinion from the EMA’s COMP supporting orphan drug designati...

Analysis

This announcement highlights a positive opinion from the EMA’s COMP supporting orphan drug designation for SGX945 in Behçet’s Disease, following Phase 2a efficacy and safety data. Historically, Soligenix’s clinical milestones—especially around SGX945 and HyBryte™—have been important drivers of investor focus. Key considerations include the next regulatory step with the European Commission, progression to later-stage trials, and how this program fits within the company’s broader rare-disease portfolio and capital plan.

Key Terms

orphan drug designation, european medicines agency, fast track designations

3 terms

orphan drug designation regulatory

"provided a positive recommendation on the Company's request for orphan drug designation"

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

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

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.

fast track designations regulatory

"SGX945 has previously been granted both orphan drug and fast track designations from the US"

A fast track designation is a regulatory status granted to a drug or therapy intended to treat a serious condition with unmet medical need, which gives the developer access to expedited interactions and review procedures with regulators. For investors, it’s like an express lane: it can shorten development and review timelines and reduce regulatory uncertainty, potentially speeding a product to market—but it does not guarantee approval or commercial success.

AI-generated analysis. Not financial advice.

PRINCETON, N.J., Feb. 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 Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) provided a positive recommendation on the Company's request for orphan drug designation for 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. The next step in the process will be ratification of the positive opinion by the European Commission.  SGX945 has previously been granted both orphan drug and fast track designations from the US 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 the positive opinion from the COMP and look forward to the European Commission granting the 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 EMA's positive opinion 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.

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 did Soligenix (SNGX) announce about EMA orphan designation on February 26, 2026?

The EMA COMP issued a positive opinion on Soligenix's orphan designation request for SGX945. According to the company, this follows Phase 2a results showing biological efficacy and safety and now awaits European Commission ratification for formal designation.

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

Orphan designation would provide up to 10 years of EU marketing exclusivity after approval. According to the company, it also offers protocol assistance and access to centralized authorization to support development and regulatory review.

How did the Phase 2a results influence the EMA COMP opinion for SGX945 (SNGX)?

Phase 2a clinical data demonstrated biological efficacy and safety in Behçet's patients, which supported the COMP positive opinion. According to the company, those proof-of-concept results were central to the regulator's review.

Has the European Commission granted orphan designation for SGX945 (SNGX) yet?

Not yet; the positive COMP opinion must be ratified by the European Commission to grant formal orphan designation. According to the company, ratification is the next step before official EU orphan status is awarded.

Does Soligenix (SNGX) already have U.S. regulatory designations for SGX945?

Yes; SGX945 previously received orphan drug and fast track designations from the FDA. According to the company, those U.S. designations remain in place alongside the recent positive COMP opinion in Europe.

What is the potential patient population cited by Soligenix for Behçet's Disease relevant to SGX945 (SNGX)?

The company cited estimates including up to 50,000 people in Europe and worldwide prevalence figures up to 1 million. According to the company, EU orphan criteria require conditions affecting no more than five in 10,000 persons.