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) reported that a 12-week comparability study of HyBryte (synthetic hypericin) versus Valchlor showed faster, more robust responses and a benign safety profile for HyBryte.
At 12 weeks, 60% of HyBryte patients met the predefined treatment success (≥50% mCAILS improvement) versus 20% for Valchlor; mean mCAILS improvement was 52.5% vs 34.7%. HyBryte had no therapy-related adverse events; Valchlor had related AEs in 60% and one withdrawal for allergic contact dermatitis.
Soligenix (Nasdaq: SNGX) reported 2025 results and program updates on March 31, 2026. The company ended 2025 with $7.9 million cash, a $11.1 million net loss, and highlighted key clinical milestones: a Q2 2026 interim analysis and H2 2026 top-line results for the Phase 3 HyBryte trial.
Regulatory progress includes EMA/EC orphan designation and UK Promising Innovative Medicine designation for dusquetide (SGX945); several publications and presentations were also announced.
Soligenix (Nasdaq: SNGX) announced the European Commission granted orphan drug designation to dusquetide (active in SGX945) for the treatment of Behçet's Disease on March 26, 2026. The decision followed a positive EMA COMP recommendation and Phase 2a results showing biological efficacy and safety.
The designation complements prior FDA orphan and fast track statuses, offers a 10-year EU marketing exclusivity after approval, and provides protocol assistance and centralized authorization access for development.
Soligenix (Nasdaq: SNGX) announced that supportive data for HyBryte™ (synthetic hypericin) in cutaneous T-cell lymphoma (CTCL) will be presented at the US Cutaneous Lymphoma Consortium Workshop on March 26, 2026.
Presentations include a Phase 2 real-world long-term treatment study by Dr. Ellen Kim and a pilot comparability poster versus Valchlor® by Dr. Brian Poligone, reporting improved outcomes with longer treatment and favorable tolerability versus mechlorethamine.
Soligenix (Nasdaq: SNGX) announced a clinical summary of HyBryte™ (synthetic hypericin) for early-stage cutaneous T-cell lymphoma published in Expert Opinion on Investigational Drugs on March 19, 2026. The review highlights HyBryte™'s reported safety, non-mutagenic mechanism, activity on thicker plaques and folliculotropic variants, and comparably improved tolerability versus mechlorethamine.
The company said it is completing patient enrollment in the confirmatory FLASH2 Phase 3 study later in 2026, with an interim analysis expected in 2Q 2026.
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.
Soligenix (Nasdaq: SNGX) announced the EMA Committee for Orphan Medicinal Products (COMP) gave a positive opinion on its request for orphan drug designation for dusquetide (SGX945) to treat Behçet's Disease, following Phase 2a results showing biological efficacy and safety. The opinion must be ratified by the European Commission.
SGX945 previously received FDA orphan drug and fast track designations. EMA orphan status would provide 10 years of EU marketing exclusivity after approval and access to centralized authorization and protocol assistance.
Soligenix (Nasdaq: SNGX) announced that Christopher J. Schaber, Ph.D., President & CEO, will deliver a corporate presentation at the BIO Investment & Growth Summit on Monday, March 2 at 3:00 PM in Miami Beach, Florida.
Registered attendees may schedule one-on-one meetings via the conference platform; non-attendees can request meetings by emailing ir@soligenix.com. The summit runs March 2–3 at Eden Roc Miami Beach.
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.