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. reports developments as a late-stage biopharmaceutical company focused on rare diseases and public health medical countermeasures. Company news centers on HyBryte (synthetic hypericin), a visible-light activated therapy program for cutaneous T-cell lymphoma, and SGX945 (dusquetide) for Behçet's Disease, including clinical data, published study results and regulatory designations.
Updates also cover the Public Health Solutions segment, including RiVax ricin toxin vaccine candidate, filovirus vaccine programs, CiVax for COVID-19 and the ThermoVax heat-stabilization platform. Recurring announcements include operating and financial results, government-supported development activities, material agreements, shareholder voting matters and governance updates.
Soligenix (Nasdaq:SNGX) highlighted the suitability of its ThermoVax thermostable vaccine platform for rapid development of a Bundibugyo virus vaccine amid the Congo outbreak. Existing bivalent and trivalent filovirus vaccines using this platform have shown thermostability, strong immune responses in animals, and up to 100% protection in non-human primates.
The platform supports ambient-temperature shipping, single-vial subunit formulations, and potential use as stand-alone or booster vaccines. According to Soligenix, development of a thermostable Bundibugyo virus vaccine, alone or in combination, could proceed rapidly given adequate funding.
Soligenix (Nasdaq: SNGX) reported Q1 2026 results and program updates on May 8, 2026. The pivotal Phase 3 FLASH2 trial of HyBryte was halted for futility after an interim analysis; the company will analyze subgroup data and may discuss next steps with EMA and FDA.
Net loss was $2.8M and cash was approximately $6.0M at March 31, 2026, with runway into the second quarter of 2027; management is evaluating strategic options including M&A and advancing SGX945.
Soligenix (Nasdaq: SNGX) reported that the Data Monitoring Committee recommended halting the pivotal Phase 3 FLASH2 trial of HyBryte for futility after the interim efficacy analysis on April 28, 2026. The company said HyBryte showed no similar efficacy signal at 18 weeks despite earlier positive results.
Soligenix reported approximately $5.9 million cash and said it will analyze the dataset, consider discussions with the EMA and FDA, explore strategic options including mergers and acquisitions, and evaluate advancing dusquetide for Behçet's Disease, which has EMA orphan designation and prior Phase 2 biological efficacy data.
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.