SNGX

PRINCETON, N.J., May 8, 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 its recent updates and financial results for the quarter ended March 31, 2026. "We remain disappointed with the unanticipated outcome of the FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that HyBryte™ (synthetic hypericin) demonstrated statistically significant reductions in cutaneous T-cell lymphoma (CTCL) lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte™ therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)." With approximately $6.0 million in cash at March 31, 2026, and cash runway into the 2nd quarter of 2027, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, and the potential of advancing SGX945 (dusquetide) for the treatment of Behçet's Disease, which demonstrated promising biological efficacy in a Phase 2 study last year while most recently receiving orphan drug designation from EMA and Promising Innovative Medicine (PIM) designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). In December, we announced the extended results of the Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. With the completion of the pilot study, we have laid the groundwork for a more detailed evaluation in this large underserved market. Soligenix Recent Updates On April 28, 2026, the Company announced that the Data Monitoring Committee completed the interim efficacy analys...

PRINCETON, N.J., April 28, 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 Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) trial evaluating HyBryte™ (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). Under the terms of the interim analysis, the study was recommended to halt for futility. "We are obviously very disappointed with the unanticipated outcome of the study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that HyBryte™ demonstrated statistically significant reductions in CTCL lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte™ therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)." Dr. Schaber continued, "With approximately $5.9 million of cash, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities as well as the potential of advancing dusquetide for the treatment of Behçet's Disease, which demonstrated promising biological efficacy in a Phase 2 study last year using the intravenous formulation and has received orphan drug designation most recently from the EMA." About HyBryte™ HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into th...

LOS ANGELES, CA - April 17, 2026 (NEWMEDIAWIRE) - Advancing clinical research while generating positive data is a critical combination in biotechnology, particularly when addressing diseases with limited treatment options. Soligenix (NASDAQ: SNGX) is demonstrating that momentum as it provides both an encouraging clinical update from its phase 3 FLASH2 study and positive comparative clinical results for its HyBryte therapy, reinforcing the company's focus on developing innovative treatments for serious conditions. Soligenix reports clinical update centered on cutaneous T-cell lymphoma ("CTCL"), a rare form of non-Hodgkin lymphoma that primarily affects the skin. The interim update highlighted that the overall blinded aggregate response rate observed in patients who have completed treatment remains consistent with prior reporting. In addition, the company reported positive results from a study evaluating HyBryte(TM) against Valchlor(R), an existing treatment option for cutaneous T-cell lymphoma. The research highlighted in these announcements centers on cutaneous T-cell lymphoma ("CTCL"), a rare form of non-Hodgkin lymphoma that primarily affects the skin. According to the National Cancer Institute, CTCL can cause persistent skin lesions, plaques and tumors, often leading to significant Read More Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX Forward Looking Statements 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...

LOS ANGELES, CA - April 2, 2026 (NEWMEDIAWIRE) - Soligenix (NASDAQ: SNGX) announced the publication of positive results from its comparability study evaluating HyBryte(TM) versus Valchlor(R) for the treatment of cutaneous T-cell lymphoma in Oncology and Therapy, highlighting favorable efficacy and safety outcomes. After 12 weeks, 60% of HyBryte-treated patients achieved treatment success compared to 20% for Valchlor, with greater average improvement and no treatment-related adverse events reported for HyBryte, while Valchlor patients experienced multiple adverse reactions, supporting HyBryte's potential as a well-tolerated therapy for early-stage CTCL. To view the full press release, visit https://ibn.fm/Eq1BX About Soligenix 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(TM) (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 Behcet's Disease. Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), 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(R). 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). Please see full terms of use an...

LOS ANGELES, CA - April 1, 2026 (NEWMEDIAWIRE) - Soligenix (NASDAQ: SNGX) reported 2025 results highlighting progress across its rare disease pipeline, including advancing its Phase 3 FLASH2 trial of HyBryte(TM) for cutaneous T-cell lymphoma with interim analysis expected in Q2 2026 and top-line results anticipated in the second half of the year. The company also noted regulatory momentum with orphan drug designation for dusquetide in Behcet's Disease, ongoing development of SGX302 and SGX945 programs and a year-end cash position of approximately $7.9 million, as it continues to pursue strategic options to support late-stage development. To view the full press release, visit https://ibn.fm/b1p2y About Soligenix 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(TM) (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 Behcet's Disease. Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), 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(R). 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). Please see full terms of use and disclaimers o...

HyBryte™ demonstrates more rapid and robust treatment response compared to Valchlor® during 12-week treatment course PRINCETON, N.J., April 2, 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 positive results of its comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy. "Being able to share the important results of this clinical trial with the world through publication in Oncology and Therapy is a privilege and highlights the clinical significance of our work with HyBryte™," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the comparability study. "Despite the small study sample size and a randomization that lead to the HyBryte™ group having patients with more extensive disease, HyBryte™ performed well and the results are consistent with previous studies demonstrating its rapid onset of action and benign safety profile compared to one of the most widely prescribed approved drugs for early-stage CTCL. The positive effect this therapy can have for patients and the outstanding safety profile that HyBryte™ continues to demonstrate are very encouraging." The purpose of the study was to obtain preliminary comparative assessment of the safety and efficacy of HyBryte™ versus Valchlor® following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. At the end of the 12-week treatment period, 60% of the HyBryte™ patients met the prospectively defined level of "Treatment Success" (≥50% improvement in their cumulative mCAILS score compared to Baseline) compared to only 20% of the Valchlor® patients; although due to the small sample size the results do not achieve statistical significance. Of the remaining two HyBryte™ patients that did not achieve treatment success, both saw a substantial (≥30%) reduction in their mCAILS score. In contrast, in the Valchlor® group, of the remaining 4 patients that did not achieve treatment success, one worsened and dropped from the study, one improved less than 30% and...

Upcoming high-impact milestones include interim analysis in Q2 2026 and top-line results in H2 2026 from HyBryte™ trial PRINCETON, N.J., March 31, 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 its recent accomplishments and financial results for the year ended December 31, 2025. "We are entering a pivotal year with several high-impact clinical and regulatory milestones across our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Key among these milestones is the interim analysis from the confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial of HyBryte™ (SGX301 or synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL) slated for the second quarter and the release of top-line results from this trial expected in the second half of 2026. The overall blinded aggregate response rate in this trial remains consistent with what was previously reported and is higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Additionally, we are advancing our inflammatory disease programs, with plans to initiate a placebo-controlled Phase 2 study of SGX945 (dusquetide) for Behçet's Disease once formulation work for home-use administration is complete in the second half of 2026. We recently reported top-line results for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy demonstrated clincial benefit in improving psoriasis lesions and was well tolerated by all patients with no drug related adverse events identified." Dr. Schaber continued, "Ending 2025 with approximately $7.9 million in cash, we remain focused on disciplined capital management to drive our strategic objectives. While our current cash balance provides operating runway into Q4 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company." Soligenix Recent...

Highlighting Positive Results in Comparison to Valchlor® and in Real-World Use PRINCETON, N.J., March 23, 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 findings from recent supportive trials with HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) are being presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (March 26, 2026), which precedes the American Academy of Dermatology (AAD) Annual Meeting. Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania, who was the Principal Investigator for the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study as well as the ongoing Phase 3 FLASH2 study, will present at the USCLC. Dr. Kim will detail positive results from the recently completed investigator-initiated study using HyBryte™ as a long-term treatment of CTCL. A poster also will be presented at the conference sharing the positive results of a study evaluating HyBryte™ versus Valchlor® (mechlorethamine) conducted by Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. The official conference program can be found here. Oral Presentation: Title: Phase 2 Investigator-Initiated Real-World Study Evaluating Topical Hypericin Ointment Photodynamic Therapy for Early-Stage Mycosis Fungoides/CTCL (RW-HPN-MF-01) presented by Dr. Ellen Kim, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania. Poster Presentation: Title: Results from a Pilot Study of HyBryte™ (topical synthetic hypericin) versus Valchlor® (mechlorethamine) in the Treatment of CTCL attended by Dr. Christopher Pullion, Medical Director, Soligenix, Inc. The poster and presentation review the Company's findings in recent supportive studies, which have demonstrated the clinical benefits of longer treatment times (Study RW-HPN-MF-01; investigator-initiated study), as well as HyBryte's™ r...

By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update Positive Results for SGX302 in Cohort 3 of Phase 2a Psoriasis Trial On December 17, 2025, Soligenix, Inc. (NASDAQ:SNGX) announced positive results from Cohort 3 of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. Cohort 3 consisted of four patients who were enrolled and treated with an improved topical gel formulation of synthetic hypericin. The gel formulation was designed to improve the patient experience as it is easier to dispense and apply to the skin. The patients were treated for 18 weeks, similar to patients in Cohort 1 and 2. For the three evaluable patients (one patient discontinued for personal reasons), noted improvements were seen in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. Importantly, one patient achieved a disease status of “Almost Clear” using the IGA and a >50% improvement in PASI score. Looking at the totality of the data generated in the Phase 2a trial thus far, its suggestive that SGX302 improves psoriatic lesions and is well tolerated. The ongoing Phase 2a trial is a randomized, double blind, placebo controlled study this is enrolling patients with mild-to-moderate, stable psoriasis covering 2% to 30% of their body. In Cohort 1, five patients received twice weekly treatment for 18 weeks with 0.25% hypericin ointment followed by light activation approximately 24 hours later. Light doses were increased by up to 1 J/cm2 on subsequent visits until mild erythema was observed. A clear biological signal was observed in the initial five patients based on an improvement in the PASI, but no patient met the definition of treatment success (IGA score of 0 or 1). The second cohort of patients received an accelerated light treatment with increases in the light dose by up to 2 J/cm2 allowing the maximum dose (25 J/cm2) to be reached by approximately week 14. Two of the four evaluable patients in Cohort 2 achieved treatment success at some point during the 18-week treatment period and the average reduction in PASI score was approximately 50%. Hypericin combined with visible light treatment could provide a safer treatment option for psoriasis patients compared to t...

Study results support advancing SGX945 in this difficult-to-treat orphan disease Results suggest potential durability of response for maintenance therapy PRINCETON, N.J., Dec. 18, 2025 /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 results from its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome". The Phase 2a study, evaluating control of oral ulcers in Behçet's Disease, reported beneficial effects for 7 of 8 patients, over the 4 weeks of treatment as well as a potentially enduring effect through the 4 weeks of follow-up. Many Behçet's Disease treatments, including the most recently approved apremilast (Otezla®), do not have an enduring impact, necessitating frequent and continuous administration. Using the Phase 3 study of apremilast as a baseline for comparison, this open-label study indicated that the area under the curve (AUC; a composite measurement of both peak number of oral ulcers and the time to resolution of the oral ulcers), average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study. Notably, outcomes in weeks 5 through 8 continued to show similar outcomes, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. The primary endpoint in the Phase 3 apremilast study was the 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. The improvements in oral pain mimicked the results in...

Optimized Gel Formulation Demonstrates Clinical Success in Third Cohort of Patients PRINCETON, N.J., Dec. 17, 2025 /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 extended results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. In this extension (Cohort 3) of the exploratory phase of the study, an additional four patients were enrolled and treated with an improved topical gel formulation of synthetic hypericin. The Cohort 3 patients were treated for the same 18-week period as Cohorts 1 and 2, but utilized an optimized gel formulation of synthetic hypericin. The gel formulation was specifically designed to improve ease of application to larger areas of the skin. SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. On average over the three evaluable patients (one patient discontinued for personal reasons), there were improvements in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. One patient achieved a disease status of "Almost Clear" using the IGA, which is considered a standard clinical measure for treatment success in psoriasis, with a substantial improvement in their PASI score, exceeding 50%. These outcomes were very similar to or improved relative to those obtained with the previous ointment formulation, as expected given the comparable release characteristics of the two formulations and the enhanced ease of application of the gel. In totality, the initial exploratory phase of the study has confirmed that SGX302 improves psoriasis lesions, consistent with the general success of photodynamic therapies in psoriasis, and is well tolerated, potentially providing a non-carcinogenic, non-mutagenic treatment for the thicker lesions found in psoriasis. "We are pleased with the preliminary findings from our ongoing Phase 2a trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The optimized gel formulation was designed to improve the patient experience, with both easier dispens...

PRINCETON, N.J., Nov. 7, 2025 /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 its recent accomplishments and financial results for the quarter ended September 30, 2025. "We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte™ demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026." Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we're focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company." Soligenix Recent Accomplishments On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte™. To view this press release, please click here. On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view...