This section highlights FDA-related milestones and regulatory updates for drugs developed by Soligenix (SNGX).
Over the past two years, Soligenix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HyBryte, SGX945, SGX302, SuVax, and MarVax. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HyBryte FDA Regulatory Timeline and Events
HyBryte is a drug developed by Soligenix for the following indication: In the treatment of cutaneous T-cell lymphoma (CTCL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HyBryte
- Announced Date:
- April 28, 2026
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. 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).
AI Summary
Soligenix, Inc. announced the Data Monitoring Committee (DMC) completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial (Fluorescent Light Activated Synthetic Hypericin 2) evaluating HyBryte™ (Synthetic Hypericin) for cutaneous T‑cell lymphoma (CTCL). In light of the interim analysis results, the company will evaluate all available data and assess potential next steps, if any, for the HyBryte development program.
The FDA awarded an Orphan Products Development grant to support an investigator‑initiated study of HyBryte for expanded treatment in patients with early‑stage CTCL, including possible home use. The grant totals $2.6 million over four years and was awarded to the University of Pennsylvania, a leading enroller in the Phase 3 FLASH study.
Together, the DMC review and the FDA grant advance evaluation of HyBryte as a light‑activated therapy for CTCL and may inform future clinical and use decisions if the full data support benefit and safety.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- April 2, 2026
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc 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.
AI Summary
Soligenix, Inc. announced that positive results from a comparability study of HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine) for treating cutaneous T‑cell lymphoma (CTCL) have been published in the journal Oncology and Therapy. The study directly compared the two topical therapies and reported favorable findings for HyBryte, presenting evidence that it performs well alongside an established treatment.
Having the results appear in a peer‑reviewed journal gives the findings added credibility. The published comparability data suggest HyBryte could be a viable alternative for skin-directed CTCL treatment, inform clinical decision making, and encourage further research into its use in patients with early‑stage disease. Soligenix framed the publication as an important step toward expanding treatment options for people living with this rare form of skin lymphoma.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- March 19, 2026
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced today that a summary of all the clinical trials completed to date evaluating HyBryte™ (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma (CTCL) has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs.
AI Summary
Soligenix, Inc. announced that a comprehensive summary of all clinical trials completed to date evaluating HyBryte™ (synthetic hypericin) as a treatment for cutaneous T‑cell lymphoma (CTCL) has been published in the peer‑reviewed journal Expert Opinion on Investigational Drugs. The article reviews the clinical development of HyBryte™, a topical light‑activated therapy designed to treat malignant skin lesions in CTCL patients, and consolidates data from completed studies into a single reference.
The published summary covers study designs, patient populations, safety findings, and efficacy results from the completed trials, giving clinicians and researchers an accessible synthesis of the available evidence. By presenting the totality of trial data, the article aims to inform clinical practice, support future research planning, and help guide decisions about next steps in HyBryte™’s development for CTCL care.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- November 19, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. announced that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix announced it has completed enrollment of the 50 patients required to trigger the planned interim analysis in its 80-patient, confirmatory Phase 3 double-blind, placebo-controlled FLASH2 study of HyBryte™ (synthetic hypericin) for cutaneous T‑cell lymphoma (CTCL). The company says the interim analysis will occur in the second quarter of 2026, with topline results expected in the second half of 2026.
FLASH2 was designed as a highly powered confirmatory trial with an anticipated overall blinded response rate of 25% (based on a 40% response in the HyBryte arm versus 10% for placebo). Among patients who have completed the treatment phase so far, the overall blinded response rate is 48%, which exceeds the trial estimate. The study’s Data Monitoring Committee can perform one formal interim analysis when about 60% (n = 48) of subjects have completed the primary endpoint at Week 18.
Investigators report a benign safety profile consistent with earlier studies. HyBryte is a topical photodynamic therapy that uses visible light to activate synthetic hypericin, targeting malignant T‑cells while avoiding ultraviolet exposure risks. Soligenix expects to complete the study on schedule.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- October 14, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced today the update of its United States (U.S.) Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL) to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of CTCL, a rare class of non-Hodgkin's lymphoma (NHL).
AI Summary
Soligenix, Inc. has refreshed its U.S. Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL) to guide the ongoing Phase 3 development of HyBryte™ (synthetic hypericin). This rare form of non-Hodgkin’s lymphoma affects the skin, and HyBryte™ uses a novel photodynamic approach activated by visible light.
The updated MAB includes dermatology and oncology experts who have served as principal investigators in the HyBryte™ program. They will advise on the pivotal FLASH2 trial, help shape clinical strategies, support global regulatory interactions, and offer insight into patient needs. Key topics include potential home-use applications, health economics, and reimbursement pathways.
Christopher J. Schaber, PhD, President and CEO of Soligenix, praised the board’s expertise. He noted their hands-on experience with HyBryte™ and expressed enthusiasm about their role in advancing the treatment toward worldwide commercialization.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- October 7, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. announced that its first Data Monitoring Committee (DMC) meeting for its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies.
AI Summary
Soligenix, Inc. announced that its first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 FLASH2 study of HyBryte™ (synthetic hypericin) in cutaneous T-cell lymphoma (CTCL) found no safety concerns. The committee determined that HyBryte™ continues to have an acceptable safety profile, consistent with data from all prior clinical trials.
The ongoing FLASH2 trial is a randomized, double-blind, placebo-controlled study enrolling about 80 patients with early-stage CTCL. It extends continuous treatment with HyBryte™ over 18 weeks to better reflect “real-world” use, building on the design of the earlier successful FLASH study.
Enrollment is proceeding on schedule for completion in the fourth quarter of 2025. Soligenix plans to provide an enrollment update later this year and to support a pre-specified, blinded interim efficacy analysis in the first half of 2026.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- September 30, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. announced today the expansion of its European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease.
AI Summary
Soligenix, Inc. expanded its European Medical Advisory Board to strengthen guidance for its Phase 3 study of HyBryte™ in early-stage cutaneous T-cell lymphoma patients. The board now includes Julia Scarisbrick, MBhons, ChB, FRCP, MD and Maarten H. Vermeer, MD, PhD, esteemed dermatology researchers from the UK and the Netherlands, respectively. These experts join three other leaders to advise on clinical strategies and trial design.
The confirmatory multicenter, double-blind, placebo-controlled trial will enroll around 80 subjects over 18 weeks. It aims to assess HyBryte™’s safety and efficacy and deliver top-line results in the second half of 2026.
The expanded board will support interactions with European health authorities and provide feedback on regulatory submissions, health economics, and reimbursement plans. Their input is intended to help Soligenix advance HyBryte™ toward commercial approval in both the EU and the UK.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- July 8, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
AI Summary
Soligenix’s update letter highlights several key milestones for its rare disease pipeline. The company is focused on advancing its confirmatory Phase 3 FLASH2 trial for HyBryte™ in early-stage cutaneous T-cell lymphoma. Top-line results from this study are expected in the second half of 2026, with updated enrollment news coming later this year. The update also notes upcoming clinical milestones, including top-line results from a Phase 2a trial for mild-to-moderate psoriasis with SGX302 in Q4 2025, and from a Phase 2a proof-of-concept trial for Behçet’s Disease with SGX945 in Q3 2025.
The CEO emphasized the company’s efforts in exploring strategic options, such as partnerships or mergers and acquisitions. These milestones, if achieved, may drive significant commercial returns and position Soligenix for stronger market success in its focused rare disease portfolio.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- April 14, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced interim results from an open-label, investigator-initiated study evaluating extended treatment with HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL). The study allows treatment for up to 54 weeks, and data from the Week 18 timepoint showed that 75% of evaluated patients achieved “Treatment Success,” which is defined as a 50% or greater improvement in lesion severity scores.
Lead investigator Dr. Ellen Kim of the University of Pennsylvania noted that this rapid response is a clear advantage over other CTCL treatments, which typically take six to 12 months to show meaningful improvements. The encouraging interim results suggest that HyBryte™ is well tolerated and may offer a faster, effective treatment option for patients with this challenging and underserved condition.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- January 14, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced an interim update on an open-label, investigator-initiated study evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). In this trial, nine patients have been treated for up to 54 weeks. Among the six subjects who have completed at least 18 weeks of therapy, over 70% achieved "Treatment Success," defined as a 50% or greater improvement in the cumulative mCAILS score compared to baseline.
Notably, three patients reached their treatment goals within the first 12 weeks, and two achieved a complete response by 18 weeks. While two patients recently started treatment and two have dropped out due to logistical reasons, early results indicate that HyBryte™ is safe and well tolerated. The positive interim results support further evaluation of extended therapy in a real-world setting.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- December 16, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc said it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. has begun enrolling patients for FLASH2, its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). This study will enroll around 80 patients in the United States and Europe. FLASH2 is a randomized, double-blind, placebo-controlled, multicenter trial that extends the treatment duration to a continuous 18-week course, compared to the previous study design. The trial’s primary efficacy endpoint will be measured after the 18-week treatment period, aiming to confirm and expand upon earlier positive results seen in patients with early-stage CTCL. With strong engagement from the CTCL community, medical advisory boards, and patient advocacy groups, accelerated enrollment is anticipated. A formal interim analysis is expected early in 2026, paving the way for potential regulatory advancement of HyBryte™ as a new treatment option.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- November 19, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease.
AI Summary
Soligenix, Inc. has formed a European Medical Advisory Board (MAB) made up of leading CTCL experts. This Board will provide crucial medical and clinical guidance as the company advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study. The trial is designed to evaluate the safety and effectiveness of HyBryte™ (synthetic hypericin) in treating early-stage cutaneous T-cell lymphoma (CTCL). Approximately 80 patients in the U.S. and Europe are expected to participate during this 18-week study, with patient enrollment scheduled to begin by the end of 2024 and top-line results anticipated in the second half of 2026.
The involvement of these respected European clinicians will help shape clinical strategies, improve study design, and guide key regulatory interactions, strengthening Soligenix’s efforts to offer a new treatment option for CTCL patients worldwide.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- October 7, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. announced that that two of its lead investigators are presenting findings from recent additional, supportive trials with HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced that two lead investigators will present new findings from additional supportive trials of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL). Dr. Ellen Kim from the University of Pennsylvania will share expanded preliminary results from her investigator-initiated study, emphasizing the usefulness of extended treatment times. Meanwhile, Dr. Brian Poligone of the Rochester Skin Lymphoma Medical Group will present data from two extra treatment studies that evaluated the advantages of longer therapy duration and increased light doses.
The results from these trials show that prolonged treatment with HyBryte™ leads to improved response rates, while the product maintains a strong safety profile with little to no systemic exposure. These presentations will take place at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland, highlighting promising advancements in CTCL therapy.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- August 1, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
PCG Digital -- Soligenix, Inc a late-stage biopharmaceutical company, is making significant strides in the treatment of Cutaneous T-Cell Lymphoma (CTCL) with its investigational drug, HyBryte™.
AI Summary
Soligenix, Inc., a late-stage biopharmaceutical company, is making significant strides in the treatment of Cutaneous T-Cell Lymphoma (CTCL) with its investigational drug HyBryte™. The company announced interim results for extended HyBryte treatment in early-stage CTCL patients, which have sparked interest due to the positive early indications. This development highlights the potential of HyBryte to provide a new treatment option for a difficult-to-treat form of lymphoma, offering hope to patients who currently have limited choices. The promising results underline Soligenix’s commitment to innovative therapies and mark an important step forward in the advancement of targeted treatments for CTCL. Overall, this progress is drawing attention in the biotech community as the company continues to explore effective methods to manage and treat this rare disease.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- July 9, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. has provided an interim update on its investigator-initiated, open-label study evaluating extended use of HyBryte™ for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). In this trial, six patients have been treated, with durations reaching up to 44 weeks. Among the four patients who have completed at least 12 weeks of therapy, three (75%) have already achieved “Treatment Success”—defined as a 50% or greater improvement in their mCAILS scores from baseline. Two of these successes were noted within the first 12 weeks, and one within 18 weeks. The study indicates that extended HyBryte™ therapy may enhance treatment outcomes, and early data suggest the treatment is safe and well tolerated, with no treatment-related adverse events reported thus far.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- June 25, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced positive clinical results from a comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine gel) in the treatment of cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced positive clinical results from a study comparing HyBryte™ (synthetic hypericin) with Valchlor® (mechlorethamine gel) in treating cutaneous T-cell lymphoma (CTCL). In this open-label study, 10 patients were divided equally between the two treatments. After 12 weeks, 60% of the patients using HyBryte™ achieved a 50% or more improvement in their mCAILS scores, compared to only 20% of the Valchlor® group. Also, HyBryte™ showed a better safety profile, as no patients experienced adverse skin reactions, while several on Valchlor® did, including one who had to stop treatment due to allergic contact dermatitis. These results suggest that HyBryte™ not only works faster but also is safer for patients with CTCL, supporting its potential as an effective alternative treatment option.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- May 21, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon
AI Summary
PRISM MarketView recently spotlighted Soligenix, Inc., emphasizing the company’s strong progress following promising Phase 3 data for HyBryte™, a synthetic hypericin treatment for cutaneous T-cell lymphoma (CTCL). The successful trial achieved statistical significance in its primary endpoint and paves the way for a second confirmatory Phase 3 study scheduled to begin in 2024 across the US and Europe. This milestone is seen as a major catalyst for the company, bolstering confidence in HyBryte’s potential for global regulatory approval. In addition to this success, Soligenix is advancing other critical programs, including studies for SGX302 in psoriasis and SGX945 for aphthous mouth ulcers in Behçet’s Disease. The company’s innovative approach is further highlighted by its use of the ThermoVax process to develop heat-stable vaccines, aiming to address unmet medical needs and expand its therapeutic portfolio.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- May 16, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced today that the results of its compatibility study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice.
AI Summary
Soligenix, Inc announced the publication of its latest study results in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. The study focused on the compatibility of HyBryte™, a synthetic form of hypericin, for treating cutaneous T-cell lymphoma (CTCL). The research highlights how HyBryte interacts within the body and its potential use as a therapeutic option for CTCL, a rare type of skin lymphoma.
The compatibility study offers insights into HyBryte’s safety and efficacy, presenting data that could influence future treatment protocols for CTCL patients. The publication in JEADV Clinical Practice underscores the significance of the findings and the ongoing scientific efforts to explore new treatments for challenging skin cancers. This development is an important step for those impacted by CTCL and provides a promising outlook for novel treatment avenues.
Read Announcement
SGX945 FDA Regulatory Timeline and Events
SGX945 is a drug developed by Soligenix for the following indication: In the Treatment of Aphthous Ulcers in Behçet's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SGX945
- Announced Date:
- March 26, 2026
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc 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.
AI Summary
Soligenix, Inc. announced that the European Commission has granted orphan drug designation to dusquetide, the active pharmaceutical ingredient in SGX945, for the treatment of Behçet's Disease. The decision followed a positive recommendation from the EMA Committee for Orphan Medicinal Products (COMP) and review of recently published Phase 2a clinical results showing biological efficacy and an acceptable safety profile in patients with Behçet's Disease.
Orphan designation recognizes the rarity of the condition and gives developers incentives to advance therapies for small patient populations. Behçet's Disease is an autoimmune condition most common along the Silk Road; estimates suggest about 18,000 cases in the U.S., over 50,000 in Europe, and up to 1,000,000 worldwide. The European orphan status may speed Soligenix's clinical and regulatory work in Europe and help bring dusquetide closer to patients who need new treatment options.
Read Announcement- Drug:
- SGX945
- Announced Date:
- March 10, 2026
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc 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.
AI Summary
Soligenix, Inc. announced that SGX945 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom 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 for inclusion in the UK Early Access to Medicines Scheme (EAMS), which allows severely ill patients with life‑threatening or seriously debilitating conditions to try promising new medicines earlier than usual. To obtain PIM status, a product must show early evidence that it could address an important unmet medical need and have a benefit‑risk profile that supports further consideration for early access.
Behçet's Disease is thought to be an autoimmune condition influenced by genetic and environmental factors and is most common along the "Silk Road" in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are about 18,000 known cases in the U.S., over 50,000 in Europe, and up to 1,000,000 people affected worldwide. SGX945 (dusquetide) is an investigational therapy, and the PIM designation could help accelerate access if later clinical data support its safety and effectiveness.
Read Announcement- Drug:
- SGX945
- Announced Date:
- February 26, 2026
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc 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.
AI Summary
Soligenix, Inc. announced that the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) gave a positive recommendation for orphan drug designation for dusquetide, the active ingredient in SGX945, for treating Behçet's Disease. COMP's recommendation followed review of recently published Phase 2a clinical results that showed biological efficacy and safety in patients with Behçet's Disease. The company plans to pursue formal orphan designation from the EMA, which can provide incentives like protocol assistance and market exclusivity to support further development.
Behçet's Disease is thought to be an autoimmune condition influenced by genetic and environmental factors and is most common along the "Silk Road" in countries such as Turkey, Iran, Japan and China. There are about 18,000 known cases in the U.S., over 50,000 in Europe, and up to 1,000,000 people affected worldwide. The EMA recommendation is an important step toward bringing a targeted therapy to this underserved patient population.
Read Announcement- Drug:
- SGX945
- Announced Date:
- December 18, 2025
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc 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".
AI Summary
Soligenix announced that results from its Phase 2a proof-of-concept study of SGX945 (dusquetide) for oral ulcers in Behçet’s Disease were published in Rheumatology (Oxford) as "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome." The small open-label pilot enrolled eight patients and reported benefit in seven during four weeks of treatment.
Key efficacy measures — area under the curve (AUC) of ulcer count over time, average number of ulcers, and oral pain — were similar to outcomes seen in the Phase 3 apremilast study. SGX945 showed a 40% improvement versus the apremilast placebo baseline at Week 4 and a sustained 32% improvement at Week 8 despite treatment stopping at Week 4, suggesting potential durability.
SGX945 was well tolerated with no treatment-related adverse events; one difficult-to-treat skin ulcer also resolved. Dusquetide is an innate defense regulator peptide.
Soligenix plans to reformulate SGX945 for subcutaneous, home-based dosing and pursue further clinical development.
Read Announcement- Drug:
- SGX945
- Announced Date:
- August 18, 2025
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc. announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet's Disease" following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease.
AI Summary
Soligenix, Inc. announced that on August 18, 2025, the FDA’s Office of Orphan Products Development granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s Disease. This decision follows a Phase 2a trial demonstrating that SGX945 is well-tolerated and shows meaningful biological efficacy and safety in patients. Under the U.S. Orphan Drug Act, this designation provides seven years of market exclusivity upon approval, eligibility for government grants, tax credits, and waiver of New Drug Application fees. It also positions Soligenix to tap into FDA support programs for rare disease therapies.
Behçet’s Disease is a chronic autoimmune disorder causing painful ulcers and inflammation, affecting as many as 1 million people worldwide. Christopher J. Schaber, PhD, President and CEO of Soligenix, expressed optimism that dusquetide could fill a critical need for patients with this hard-to-treat condition.
Read Announcement- Drug:
- SGX945
- Announced Date:
- July 31, 2025
- Indication:
- In the Treatment of Aphthous Ulcers in Behçet's Disease
Announcement
Soligenix, Inc announced that it has completed its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease and achieved the study objective of demonstrating biological efficacy.
AI Summary
Soligenix, Inc. completed its Phase 2a proof of concept study of SGX945 (dusquetide) in Behçet’s Disease and achieved biological efficacy.
This open-label trial used endpoints similar to an apremilast study in oral ulcers and compared SGX945 outcomes to apremilast and placebo arms.
After 4 weeks, SGX945 showed a 40% improvement in ulcer count over time versus placebo, versus 37% for apremilast, and benefits lasted through week 8.
Unlike apremilast, SGX945 stopped at week 4 but still showed 32% improvement at week 8 without continuous dosing, suggesting a durable response with twice-weekly treatment.
Seven of eight patients experienced fewer, shorter ulcers and less pain; one skin ulcer resolved. SGX945 was well tolerated with no treatment-related adverse events.
Soligenix will reformulate SGX945 for home-based subcutaneous use and plans a placebo-controlled study to confirm its potential in managing mucocutaneous symptoms of Behçet’s Disease.
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SGX302 FDA Regulatory Events
SGX302 is a drug developed by Soligenix for the following indication: Mild-to-Moderate Psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SGX302
- Announced Date:
- December 17, 2025
- Indication:
- Mild-to-Moderate Psoriasis
Announcement
Soligenix, Inc announced extended results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis.
AI Summary
Soligenix reported extended results from Cohort 3 of its Phase 2a study of SGX302 (synthetic hypericin) in mild-to-moderate psoriasis. Four patients were enrolled and treated for 18 weeks with an optimized topical gel designed for easier application to larger skin areas.
SGX302 gel was well tolerated with no drug-related adverse events. Of three evaluable patients (one withdrew for personal reasons), all showed improvements in Investigator Global Assessment (IGA), Psoriasis Area and Severity Index (PASI), simplified psoriasis index, Dermatology Life Quality Index, and Skindex-29. One patient reached “Almost Clear” by IGA and had a PASI reduction exceeding 50%. Results were similar or better than the prior ointment, attributed to comparable release characteristics and better usability of the gel.
The company said the exploratory phase confirms SGX302 can improve psoriasis lesions and is well tolerated, supporting further clinical evaluation of the gel formulation.
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SuVax FDA Regulatory Events
SuVax is a drug developed by Soligenix for the following indication: For the Prevention and Post-Exposure Prophylaxis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SuVax
- Announced Date:
- June 14, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc. announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™).
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʽi at Mānoa will present important data on their thermostable vaccine platform. The presentation, taking place at the upcoming ASM Microbe Conference in Atlanta, will focus on the vaccine candidates developed for filoviruses. Specifically, Professor Lehrer will share key results from the filovirus vaccines SuVax™ for Sudan ebolavirus and MarVax™ for Marburg marburgvirus. These vaccine candidates use a protein subunit approach, combined with a novel adjuvant and safe excipients, to create a heat-stable, single-vial formulation. This technology simplifies storage and distribution by eliminating the need for extremely low temperatures while still inducing a strong immune response. The data presented at the conference highlights significant progress in vaccine development that could help protect against deadly outbreaks caused by these filoviruses.
Read Announcement- Drug:
- SuVax
- Announced Date:
- May 21, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming Vaccine Technology IX, Los Cabos, Mexico, May 19-24, 2024.
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʻi at Mānoa will present key data on the company’s thermostable vaccine technology platform at the Vaccine Technology IX conference in Los Cabos, Mexico from May 19-24, 2024. This presentation will highlight important advancements in vaccine formulations for challenging filoviruses.
Professor Lehrer’s talk will focus on data from vaccine candidates targeting Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). Developed in collaboration with UHM, the technology uses a combination of Generally Recognized as Safe excipients and a freeze-drying process to produce a single-vial vaccine that remains stable at higher temperatures. Early studies in non-human primates have shown complete protection, marking a promising step forward in combatting these deadly viruses.
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MarVax FDA Regulatory Events
MarVax is a drug developed by Soligenix for the following indication: Against Marburg Marburgvirus Infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MarVax
- Announced Date:
- May 21, 2024
- Indication:
- Against Marburg Marburgvirus Infection
Announcement
Soligenix, Inc announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming Vaccine Technology IX, Los Cabos, Mexico, May 19-24, 2024.
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʽi at Mānoa will present key data at the Vaccine Technology IX Conference in Los Cabos, Mexico from May 19-24, 2024. His presentation will showcase the company’s thermostable vaccine technology platform developed in collaboration with UHM. The data will include results from the filovirus vaccine candidates SuVax™ for Sudan ebolavirus and MarVax™ for Marburg marburgvirus. These vaccines, designed using a novel lyophilization process and GRAS excipients, have shown promising results in preclinical studies, providing 100% protection in non-human primate challenge trials. The thermostable formulations could simplify distribution, as they remain effective at higher temperatures. This presentation highlights a significant step forward in developing accessible, heat-stable vaccines to combat diseases caused by filoviruses.
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