Soligenix Receives Orphan Drug Designation from the European Commission for SGX945 for the Treatment of Behçet's Disease Accessibility StatementSkip Navigation 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 th ...

Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX March 27, 2026 Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products and product candidates and their development, regulatory approvals, ability to commercialize our products and product candidates and a ...

Core Insights - Soligenix, Inc. announced positive results from supportive trials of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL), which will be presented at the US Cutaneous Lymphoma Consortium Workshop [1][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly HyBryte™ (SGX301), a novel photodynamic therapy for CTCL [19] Clinical Study Results - The Phase 3 FLASH trial showed that 16% of patients treated with HyBryte™ achieved at least a 50% reduction in lesions compared to 4% in the placebo group, with a statistically significant p-value of 0.04 [9] - In the second treatment cycle, 40% of patients receiving 12 weeks of HyBryte™ treatment showed a positive response, significantly higher than the placebo group [10] - In the optional third treatment cycle, 49% of patients who received HyBryte™ throughout all cycles demonstrated a positive treatment response, indicating its sustained efficacy [11] Safety and Efficacy - HyBryte™ has been shown to be safe and well-tolerated across all treatment cycles, with no significant systemic absorption or DNA damage associated with its use, making it a safer alternative to existing therapies [12] - The treatment's mechanism avoids risks of secondary malignancies and significant side effects commonly associated with other therapies [12] Regulatory and Development Updates - The FDA and EMA require a second successful Phase 3 trial for marketing approval, leading to the initiation of the FLASH2 study, which aims to replicate the successful design of the first FLASH trial [13][14] - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for early-stage CTCL treatment [16] Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [17][18]

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Core Viewpoint - Soligenix, Inc. announced the publication of a clinical summary for HyBryte™ in the journal "Expert Opinion on Investigational Drugs," highlighting its potential as a treatment for cutaneous T-cell lymphoma (CTCL) [1][2]. Clinical Trials and Efficacy - HyBryte™ (synthetic hypericin) has shown promising results in clinical trials, with a unique mechanism of action and an excellent safety profile, positioning it as a potential first-line treatment for early-stage CTCL [3][4]. - In the Phase 3 FLASH trial, 16% of patients treated with HyBryte™ achieved at least a 50% reduction in lesions compared to 4% in the placebo group, demonstrating statistical significance (p=0.04) [5]. - The second treatment cycle showed a 40% response rate in patients receiving 12 weeks of HyBryte™ treatment, significantly higher than the placebo group [6]. - In the optional third treatment cycle, 49% of patients who received HyBryte™ throughout all cycles demonstrated a positive treatment response [7]. Safety Profile - HyBryte™ is noted for its safety, with no evidence of systemic absorption or DNA damage, making it a safer alternative to current therapies that carry significant side effects [8]. - The treatment has been well tolerated across all three treatment cycles, with no serious safety issues reported [7][8]. Regulatory Status and Future Studies - HyBryte™ has received orphan drug and fast track designations from the FDA, and orphan designation from the EMA, facilitating its development for CTCL [4]. - A second confirmatory Phase 3 study, FLASH2, is underway, with an interim analysis expected in Q2 2026, aiming to replicate the successful design of the first FLASH study [9][10]. - The FDA has awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study for expanded treatment of HyBryte™ in early-stage CTCL [12]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current approved front-line therapies available [13][14]. - Soligenix is focused on addressing unmet medical needs in rare diseases, with HyBryte™ as a key product in its pipeline [14].

Core Viewpoint - Soligenix, Inc. announced that its product SGX945 (dusquetide) has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Behçet's Disease, marking a significant step towards potential early access for patients with severe conditions [1][2]. Group 1: Product Development and Designation - SGX945 has been granted PIM designation, which is a prerequisite for inclusion in the UK Early Access to Medicines Scheme (EAMS) [1]. - The PIM designation criteria include a favorable benefit-risk balance, major advantages over current treatments, and addressing a life-threatening condition with high unmet medical need [1]. - The company aims to leverage the EAMS scheme to expedite the availability of SGX945 to patients suffering from Behçet's Disease [1]. Group 2: Clinical Data and Efficacy - Dusquetide has shown positive efficacy results in Phase 2 and 3 clinical studies, including a 40% improvement in ulcer reduction compared to placebo in Behçet's Disease patients [1]. - The treatment demonstrated sustained improvement, with a 32% improvement at Week 8 after treatment cessation, compared to apremilast's 41% improvement at the same time point [1]. - SGX945 was well-tolerated with no treatment-related adverse events reported, contrasting with common side effects associated with apremilast [1]. Group 3: Market Context and Disease Overview - Behçet's Disease is an inflammatory disorder with significant symptoms affecting quality of life, including mouth sores, skin rashes, and genital ulcers, impacting approximately 18,000 known cases in the U.S. and over 50,000 in Europe [2]. - Current treatments for Behçet's Disease primarily manage symptoms and include corticosteroids and immunosuppressants, which have limited long-term efficacy and significant side effects [2]. - Apremilast is the only approved drug for Behçet's Disease, used as a maintenance therapy, but it requires continuous administration and is associated with high costs and side effects [2].

Core Viewpoint - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs, and it will present at the BIO Investment & Growth Summit on March 2, 2026 [1] Company Overview - Soligenix is developing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and is seeking regulatory approvals following the successful completion of its second Phase 3 study [1] - The company is also expanding its product pipeline, which includes SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [1] - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine, and vaccines targeting filoviruses and COVID-19, utilizing the ThermoVax® heat stabilization technology [1] Upcoming Events - Christopher J. Schaber, Ph.D., President & CEO of Soligenix, will deliver a corporate presentation at the BIO Investment & Growth Summit on March 2, 2026, in Miami Beach, Florida [1] Funding and Support - The development of Soligenix's vaccine programs has been supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA [1]

Core Insights - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, highlighting significant progress in its clinical pipeline and upcoming milestones for 2026 [1][2] Clinical Developments - Top-line results from the Phase 2a trial of SGX302 for mild-to-moderate psoriasis showed that the gel therapy was well tolerated, with one patient achieving "Almost Clear" status and over 50% improvement in PASI score [1] - The Phase 2a trial of SGX945 for Behçet's Disease demonstrated biological efficacy, with results comparable to apremilast, indicating potential for home-based treatment in future studies [1] - Ongoing studies for HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) show promising results, with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1] Market Opportunities - Peak annual net sales for HyBryte™ in the U.S. are expected to exceed $90 million, with a total addressable worldwide CTCL market estimated at over $250 million annually [2] - The psoriasis market opportunity with SGX302 is projected to exceed $1 billion annually, while SGX945 for Behçet's Disease is estimated at approximately $200 million annually [2] - Overall, the potential for significant commercial returns across the rare disease pipeline is estimated at around $2 billion in global annual sales [2] Financial Position - As of September 30, 2025, the company reported approximately $10.5 million in cash, with additional non-dilutive funding of about $500 thousand from New Jersey's NOL sales program [2] - The company is focused on advancing its development programs and has sufficient capital to meet its goals through 2026 [2]

Core Insights - Soligenix, Inc. has published results from its Phase 2a study of SGX945 (dusquetide) for treating Behçet's Disease, indicating promising outcomes for patients with oral ulcers associated with the condition [1][2][5] Study Results - The Phase 2a study showed beneficial effects for 7 out of 8 patients over 4 weeks of treatment, with sustained improvements noted during the follow-up period [2][4] - SGX945 demonstrated a 40% improvement in the area under the curve (AUC) for the mean number of ulcers compared to placebo, while the approved drug apremilast showed a 37% improvement [3][9] - Improvements in oral pain were consistent with the AUC measurements, with 7 of 8 patients reporting benefits such as reduced duration and number of oral ulcers [4][9] Safety and Tolerability - SGX945 was well-tolerated with no treatment-related adverse events reported, contrasting with common side effects associated with apremilast, such as diarrhea (41%), nausea (19%), and headache (14%) [4][9] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment via subcutaneous injection and aims to expand its development into other inflammatory conditions related to the innate immune system [5][10] - Soligenix holds a strong intellectual property position for dusquetide and has received Fast-Track and Orphan Drug designations from the FDA for its treatment of Behçet's Disease [10][12] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs, particularly in managing symptoms like oral ulcers [11][12] - Current treatments, including apremilast, require continuous administration and are associated with high costs and side effects, highlighting the potential market opportunity for SGX945 [14][15]

Core Insights - Soligenix, Inc. announced extended results from its Phase 2a trial of SGX302 for mild-to-moderate psoriasis, enrolling an additional four patients with an improved topical gel formulation [1] Group 1: Trial Results - SGX302 gel therapy was well tolerated, with no drug-related adverse events reported among patients [2] - Improvements were observed in multiple assessment metrics, including Investigator Global Assessment (IGA) and Psoriasis Activity and Severity Index (PASI) [2] - One patient achieved "Almost Clear" status on the IGA, with a PASI score improvement exceeding 50% [3] Group 2: Comparison with Previous Formulation - The outcomes from the gel formulation were similar or improved compared to the previous ointment formulation, attributed to comparable release characteristics and enhanced application ease [4] Group 3: Overall Study Findings - The initial exploratory phase confirmed that SGX302 effectively improves psoriasis lesions and is well tolerated, suggesting a potential non-carcinogenic treatment option [5] - Following the announcement, Soligenix's stock price decreased by 21.05%, trading at $1.21 [5]