Welcome to our dedicated page for Soligenix news (Ticker: SNGX), a resource for investors and traders seeking the latest updates and insights on Soligenix stock.
Soligenix, Inc. (NASDAQ: SNGX) is repeatedly described in its public communications as a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. News about SNGX often centers on progress across its two segments, Specialized BioTherapeutics and Public Health Solutions, and provides updates on clinical trials, regulatory designations, advisory boards and financing activities.
In the Specialized BioTherapeutics segment, recent press releases highlight the ongoing confirmatory Phase 3 FLASH2 study of HyBryte™ (SGX301, synthetic hypericin sodium) for cutaneous T-cell lymphoma (CTCL), including enrollment milestones and interim safety reviews. Additional news covers Phase 2a clinical results for SGX302 in mild-to-moderate psoriasis, emphasizing improvements in standard psoriasis indices with synthetic hypericin-based photodynamic therapy, and publications and regulatory designations for SGX945 (dusquetide) in Behçet's Disease, including orphan drug designation from the FDA.
Coverage of Soligenix also includes updates on its innate defense regulator (IDR) technology platform, describing dusquetide’s role in modulating the innate immune response, and on its Public Health Solutions programs such as the RiVax® ricin toxin vaccine candidate, filovirus vaccines and CiVax™ for COVID-19, which use the ThermoVax® heat-stabilization platform and have received support from agencies like NIAID, DTRA and BARDA.
Investors following SNGX news can expect announcements about clinical trial milestones, peer-reviewed publications, FDA orphan and fast track designations, medical advisory board expansions in CTCL, as well as capital markets events such as public offerings and Nasdaq listing compliance updates. Bookmarking the SNGX news page on Stock Titan can help track these developments in one place as the company advances its rare-disease and biodefense pipeline.
Soligenix (Nasdaq: SNGX) provided a Feb. 12, 2026 update on clinical progress, enrollment and finances. Key points: FLASH2 Phase 3 top-line results expected H2 2026 with an interim analysis in 2Q; 66 of 80 patients enrolled as of Feb. 10. The company reported ~$10.5M cash (Q3 2025) plus ~$0.5M NOL funding and reiterated commercial estimates including U.S. peak HyBryte™ sales >$90M and a global opportunity near $2B.
Soligenix (Nasdaq: SNGX) announced publication of Phase 2a results for SGX945 (dusquetide) in Behçet's Disease (oral aphthous ulcers) on December 18, 2025. In an open-label pilot (n=8) SGX945 showed beneficial effects for 7 of 8 patients during 4 weeks of treatment and maintained effects through a 4-week follow-up.
Using the apremilast Phase 3 AUC endpoint, SGX945 showed a 40% improvement at Week 4 versus placebo (apremilast 37%) and a 32% improvement at Week 8 despite treatment stopping at Week 4 (apremilast 41% at Week 8). No treatment-related adverse events reported.
Soligenix (Nasdaq: SNGX) reported topline extended results from the Phase 2a exploratory extension (Cohort 3) of SGX302 (synthetic hypericin) for mild-to-moderate psoriasis on Dec 17, 2025.
Cohort 3 enrolled four patients treated 18 weeks with an optimized topical gel formulation. Three evaluable patients showed improvements across IGA, PASI, simplified psoriasis index, DLQI and Skindex-29. One patient reached IGA “Almost Clear” with PASI improvement exceeding 50%. SGX302 gel was well tolerated with no drug-related adverse events reported. Company said results are similar or improved versus the prior ointment and supports further development while advancing the HyBryte Phase 3 program for CTCL with topline results expected in H2 2026.
Soligenix (NASDAQ: SNGX) announced placement in an editorial published by BioMedWire on Dec 5, 2025, highlighting the growing rare-disease burden among aging U.S. populations and the need for novel therapies.
The company is described as a late-stage biopharmaceutical developer advancing multiple rare-disease programs, including HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma, which is stated to be in its final confirmatory trial before seeking global marketing authorization.
The piece frames Soligenix’s programs at a pivotal intersection of scientific innovation and national health-policy focus on chronic and rare diseases.
Soligenix (NASDAQ: SNGX) announced placement in an editorial highlighting chronic rare diseases and the role of its lead therapy HyBryte (synthetic hypericin) for cutaneous T‑cell lymphoma (CTCL).
The company is described as a late‑stage biopharmaceutical conducting the final confirmatory clinical study required before filing for worldwide marketing approval for HyBryte. The piece places Soligenix at the intersection of medical innovation and federal health policy amid rising rare‑disease burdens, noting that more than 30 million Americans are affected by rare diseases (NIH figure).
Soligenix (Nasdaq: SNGX) reported completion of enrollment of 50 of 80 patients required for a planned interim analysis in its confirmatory Phase 3 FLASH2 study of HyBryte for cutaneous T‑cell lymphoma (CTCL).
The company said the blinded study response rate to date is 48%, above the study's anticipated blinded estimate of 25%. The Data Monitoring Committee will perform the interim analysis in Q2 2026 and topline results are expected in the second half of 2026. The announcement references prior Phase 3 FLASH results (49% response at 18 weeks) and an investigator study reporting 75% response at 18 weeks. The company also noted a benign safety profile observed to date.
Soligenix (Nasdaq: SNGX) reported third quarter 2025 results and recent program updates on Nov 7, 2025. The company reported no revenue for Q3 2025 and a net loss of $2.5 million (($0.58) per share). Research and development expense was $1.6 million for the quarter, driven by costs for a second confirmatory Phase 3 CTCL trial and contract manufacturing.
Clinical progress: the first DMC review of the Phase 3 HyBryte™ CTCL study found no safety concerns, enrollment remains on track, and top-line Phase 3 results are anticipated in H2 2026. Cash was approximately $10.5 million at Sept 30, 2025; management said this provides runway through 2026 while evaluating strategic options.
Soligenix (Nasdaq: SNGX) announced an update to its U.S. Medical Advisory Board (MAB) for cutaneous T‑cell lymphoma (CTCL) to support the Phase 3 FLASH2 pivotal study of HyBryte (synthetic hypericin) on October 14, 2025. The refreshed MAB includes dermatology and oncology leaders who have served as HyBryte principal investigators and will advise on clinical strategy, patient needs, potential home‑use applications, health economics, reimbursement and worldwide regulatory interactions. The release lists MAB members and credentials, noting clinical experience such as treating >1,000 lymphoma patients and principal‑investigator roles across HyBryte trials.
Soligenix (Nasdaq: SNGX) reported that the first Data Monitoring Committee meeting for its confirmatory Phase 3 FLASH2 study of HyBryte found no safety concerns and an acceptable safety profile consistent with prior trials.
Enrollment is proceeding on track with an ~80-subject randomized, double-blind, placebo-controlled design; an enrollment update is expected in 4Q2025. The DMC will support a pre-specified blinded interim efficacy analysis targeted for 1H2026, and topline results remain planned for the second half of 2026. The summary notes the earlier FLASH Phase 3 observed a 49% treatment response (p<0.0001) in patients completing 18 weeks of therapy.
Soligenix (NASDAQ:SNGX) has announced the expansion of its European Medical Advisory Board (MAB) to support its confirmatory Phase 3 study of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL). The expanded board includes two new esteemed dermatologists, bringing the total to five internationally renowned physicians.
The Phase 3 study will be an 18-week, multicenter, double-blind, placebo-controlled trial evaluating HyBryte™ in early-stage CTCL patients. The study aims to enroll approximately 80 patients with top-line results expected in the second half of 2026.
The expanded MAB will provide strategic guidance for the clinical study, regulatory interactions, and aspects such as health economics and reimbursement. The board includes distinguished members from France, Italy, Spain, the UK, and the Netherlands, each bringing extensive experience in CTCL research and treatment.
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