Soligenix Announces SGX945 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency

Rhea-AI Summary

Soligenix (Nasdaq: SNGX) announced on March 10, 2026 that SGX945 (dusquetide) received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet's Disease. The PIM designation is a prerequisite for consideration in the UK Early Access to Medicines Scheme (EAMS). Soligenix cited Phase 2 Behçet's clinical data and prior oral mucositis study consistency as the basis for the designation. Management said it will work with the MHRA to pursue EAMS access and potentially enable earlier patient availability.

Positive

• PIM designation granted for SGX945 on March 10, 2026
• Designation enables pathway toward UK EAMS early patient access
• PIM decision cites Phase 2 Behçet's data and prior study consistency

Negative

• PIM designation is a preliminary regulatory step, not marketing approval
• EAMS inclusion is not guaranteed and requires further MHRA review
• No timeline or financial impact disclosed for commercialization or access

News Market Reaction – SNGX

+2.50%

3 alerts

+2.50% Session close to close

+2.4% Peak Tracked

-8.0% Trough Tracked

$12.41M Market Cap

0.5x Rel. Volume

In the Mar 10 session, SNGX gained 2.50%, reflecting a moderate positive market reaction. Argus tracked a peak move of +2.4% during that session. Argus tracked a trough of -8.0% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds another regulatory milestone for SGX945, with UK PIM status building on earli...

Analysis

This announcement adds another regulatory milestone for SGX945, with UK PIM status building on earlier Phase 2 data in Behçet’s Disease. Recent history shows multiple positive updates across SGX945, HyBryte™ and SGX302, alongside disclosures of cash of about $10.5M and expectations for HyBryte™ peak sales above $90M. Investors monitoring this story would likely focus on future interactions with the MHRA, potential entry into the UK Early Access to Medicines Scheme, and upcoming Phase 3 readouts as key validation points.

Historical Context

5 past events · Latest: Feb 26 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 26	Orphan designation opinion	Positive	-2.5%	EMA committee issued positive orphan drug opinion for SGX945 in Behçet’s Disease.
Feb 24	Conference presentation	Neutral	+4.5%	Company scheduled CEO presentation and meetings at BIO Investment & Growth Summit.
Feb 12	Pipeline and cash update	Positive	-1.9%	Outlined FLASH2 Phase 3 timing, enrollment status, and cash of about $10.5M.
Dec 18	Phase 2 Behçet’s data	Positive	+0.0%	Phase 2a SGX945 data in Behçet’s published showing benefit and no related AEs.
Dec 17	Psoriasis trial results	Positive	-19.1%	Positive Cohort 3 results for SGX302 gel in psoriasis with good tolerability.

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

Pattern Detected

Recent clinically and regulatory positive headlines often coincided with flat or negative next-day moves, suggesting a tendency for weak price follow-through on good news.

Recent Company History

Over the past few months, Soligenix has highlighted multiple milestones around SGX945 and its broader pipeline. On Dec 18, 2025, positive Phase 2a Behçet’s data were published with no immediate price move. A Feb 12, 2026 pipeline and cash update, including $10.5M cash and HyBryte™ peak sales expectations above $90M, saw shares down modestly. A Feb 26, 2026 positive EMA orphan opinion for SGX945 led to a -2.54% move. Against this backdrop, today’s UK PIM designation continues a string of incremental regulatory validations for SGX945.

Key Terms

medicines and healthcare products regulatory agency, mhra, early access to medicines scheme, eams, +2 more

6 terms

medicines and healthcare products regulatory agency regulatory

"by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment"

A medicines and healthcare products regulatory agency is a government body that assesses, licenses and monitors the safety, effectiveness and quality of medicines, vaccines and medical devices before and after they reach the market. For investors, its decisions act like a building inspector’s approval — they determine whether a product can be sold, the timing and scope of market access, and can therefore quickly affect a company’s revenue prospects, costs and valuation.

mhra regulatory

"by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment"

The MHRA is the United Kingdom’s government agency that checks and approves medicines, medical devices and vaccines before they can be sold, and monitors their safety once on the market. For investors, MHRA decisions act like a building inspector’s sign-off or a traffic controller’s clearance—approval clears the way for sales and revenue, while safety warnings, recalls or delays can slow launches, raise costs or hurt a product’s commercial prospects.

early access to medicines scheme regulatory

"towards inclusion in the UK Early Access to Medicines Scheme (EAMS)."

A government program that allows patients with serious or life-threatening conditions to receive promising new medicines before full regulatory approval, based on early safety and efficacy data. For investors, it can act like a limited pilot release that brings early real-world use and revenue, reduces some development timing risk and signals regulator interest; however, it is not a substitute for final approval and carries remaining safety, reimbursement and commercial risks.

eams regulatory

"towards inclusion in the UK Early Access to Medicines Scheme (EAMS)."

An early access to medicines scheme (EAMS) is a regulatory program that allows patients to use promising but not yet fully approved treatments before formal market authorization, typically when no adequate alternatives exist. For investors, EAMS status can shorten the time before a product reaches paying patients and reduce commercial risk—think of it as a temporary permit that lets a product start proving its real-world value and revenue potential while final approval is still pending.

phase 2 medical

"based on the Phase 2 clinical data in Behçet's Disease, in conjunction with"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

behçet's disease medical

"for the treatment of Behçet's Disease. The PIM designation is the first step"

A chronic inflammatory condition that causes recurring sores, eye inflammation and inflammation of blood vessels throughout the body, with symptoms and severity that vary widely between people. It matters to investors because the disease’s unpredictable course and need for long-term treatment shape the market for therapies, influence clinical trial design and regulatory approvals, and affect a company’s revenue and costs much like a customer base with irregular, high ongoing needs.

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

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PRINCETON, N.J., March 10, 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 SGX945 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Behçet's Disease.

The PIM designation is the first step and a prerequisite towards inclusion in the UK Early Access to Medicines Scheme (EAMS). EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible. The criteria products must meet to obtain the PIM designation are:

1. Criterion 1 – The condition is life-threatening or seriously debilitating with a high unmet medical need.
2. Criterion 2 – The medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition currently used in the UK.
3. Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive benefit risk balance. 

"We are excited that the MHRA agrees that dusquetide meets the specified criteria for PIM designation based on the Phase 2 clinical data in Behçet's Disease, in conjunction with the consistency that has been observed in previous clinical studies in oral mucositis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to working with the MHRA to advance the program and leverage the potential benefits of the EAMS scheme to make this important product available to patients and physicians facing the challenges of Behçet's Disease."

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 eight 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, as well as receiving a positive opinion from the European Medicines Agency (EMA) on the Request for Orphan Drug Designation and Promising Innovative Medicine (PIM) designation from the 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 MHRA PIM designation for SGX945 (SNGX) on March 10, 2026 mean?

It means SGX945 met criteria to be considered promising for Behçet's Disease by the MHRA. According to the company, this designation is a prerequisite for the UK Early Access to Medicines Scheme and reflects Phase 2 data plus prior clinical consistency.

Does the PIM designation for SGX945 (SNGX) guarantee patient access through EAMS?

No, PIM designation does not guarantee EAMS inclusion or approval. According to the company, PIM is the first step toward EAMS; further MHRA review and additional evidence are required for patient access under EAMS.

Why did the MHRA grant PIM designation to SGX945 for Behçet's Disease (SNGX)?

The MHRA determined SGX945 likely meets PIM criteria based on benefit-risk and unmet need. According to the company, the determination referenced Phase 2 Behçet's results and consistency with earlier oral mucositis studies.

How might the PIM designation affect Soligenix's (SNGX) development timeline in the UK?

PIM may accelerate regulatory engagement and pathway planning with the MHRA but does not fix dates. According to the company, it opens the potential route to EAMS, which could enable earlier patient access if subsequent steps succeed.

What evidence supported the PIM designation for SGX945 (SNGX) in Behçet's Disease?

The designation was supported by Phase 2 clinical data in Behçet's Disease and consistency with prior studies. According to the company, those data formed the basis for meeting the MHRA's PIM criteria.