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 (SNGX) announced positive interim results from an FDA-funded study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). After 18 weeks of treatment, 75% of patients achieved Treatment Success, defined as ≥50% improvement in mCAILS score.
Of the eight evaluable patients through Week 18, four completed the 54-week treatment with an average maximum improvement of 85% in mCAILS score, three remain on treatment, and one dropped out due to logistical issues. The study, led by Dr. Ellen Kim at Penn Cutaneous Lymphoma Program, demonstrates HyBryte's™ rapid response compared to other CTCL therapies that typically take 6-12 months for meaningful results.
The ongoing open-label study aims to enroll approximately 20 patients, supported by an FDA Orphan Products Development Grant of up to $2.6 million. The results reinforce HyBryte's™ potential as a safe and fast-acting therapy for this rare cancer.
Soligenix (NASDAQ: SNGX) has published preclinical efficacy results for CiVax™, their thermostabilized subunit vaccine against SARS-CoV-2. The study demonstrated that combining a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) with a CiVax™ booster induced broader protection against COVID-19 variants in non-human primates compared to a traditional 2-shot mRNA vaccination series.
The research, conducted in collaboration with Dr. Axel Lehrer from the University of Hawaiʻi, showed that CiVax™ generates rapid-onset multi-variant booster responses when used in a heterologous prime-boost approach. A key advantage of CiVax™ is its thermostability, allowing ambient temperature shipping and requiring only sterile water reconstitution before use.
The vaccine leverages Soligenix's ThermoVax® platform, which has successfully stabilized vaccines for ricin toxin and filoviruses. This technology enhances standard protein subunit vaccination, potentially offering a safer alternative that doesn't require strict cold-storage requirements like mRNA vaccines.
Soligenix (SNGX) reported its financial results for the year ended December 31, 2024, with a net loss of $8.3 million ($4.98 per share) compared to $6.1 million in 2023. Revenue decreased to $0.1 million from $0.8 million in the previous year.
The company maintains $7.8 million in cash, providing operational runway through 2025. Research and development expenses increased to $5.2 million from $3.3 million, while general and administrative expenses decreased to $4.2 million from $4.5 million.
Key developments include patient enrollment for the confirmatory Phase 3 study of HyBryte™ in CTCL treatment, with top-line results expected in 2026. Additionally, top-line results from Phase 2 studies for SGX945 in Behçet's disease and SGX302 in psoriasis are anticipated in the second half of 2025.
Soligenix (NASDAQ: SNGX) announced upcoming presentations of their HyBryte™ (synthetic hypericin) treatment studies at two major medical conferences in March 2025. The presentations will showcase data from recent supportive trials in cutaneous T-cell lymphoma (CTCL) and psoriasis treatments.
The findings will be presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop on March 6 and the American Academy of Dermatology (AAD) Annual Meeting from March 7-11 in Orlando, Florida. Dr. Ellen Kim from Penn Cutaneous Lymphoma Program will present results from an ongoing investigator-initiated study on HyBryte™'s long-term CTCL treatment, while Dr. Neal Bhatia will discuss topical and photodynamic therapy considerations at AAD.
The presentations will include findings from recent supportive studies demonstrating longer treatment efficacy, minimal systemic hypericin exposure after topical application, and comparative efficacy against Valchlor®.
Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in the upcoming BIO CEO & Investor Conference. The event is scheduled for February 10-11, 2025 in New York, N.Y.
The company, which focuses on developing and commercializing products for unmet medical needs in rare diseases, will deliver a corporate presentation during the conference. Registered attendees have the opportunity to schedule one-on-one meetings with Soligenix management through the conference scheduling platform. Those unable to attend can arrange meetings by contacting ir@soligenix.com.
Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in two upcoming investor conferences. The company will present at the Sequire Investor Summit from January 21-23 at Condado Vanderbilt, Puerto Rico, and The Microcap Conference from January 28-30 at Borgata Hotel Casino & Spa in Atlantic City, N.J.
Key management members will be available for one-on-one meetings during both conferences. Registered attendees can schedule meetings through the conference platforms. Investors unable to attend can arrange meetings by contacting ir@soligenix.com.
Soligenix (SNGX) announced interim results from an open-label study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). The study, supported by a $2.6M FDA grant, shows promising outcomes with over 70% of eligible patients (5 of 6) achieving 'Treatment Success' - defined as ≥50% improvement in mCAILS score.
Of the nine enrolled patients treated for up to 54 weeks, three achieved Treatment Success within 12 weeks, with two reaching complete response by week 18. Two patients recently started the study, while two dropped out for logistical reasons, with one showing >30% improvement at Week 18. The treatment appears safe and well-tolerated across all patients.
The study (RW-HPN-MF-01) aims to enroll approximately 20 U.S. patients for up to 12 months of twice-weekly dosing, with potential transition to home use. This research extends previous positive Phase 2 and 3 clinical trials results.
Soligenix (SNGX) has initiated patient enrollment for its confirmatory Phase 3 FLASH2 study evaluating HyBryte™ for treating cutaneous T-cell lymphoma (CTCL). The study builds on a previous successful Phase 3 FLASH trial, which showed a 49% treatment response rate after 18 weeks of therapy.
The new FLASH2 study will enroll approximately 80 patients with early-stage CTCL across the U.S. and Europe. Unlike the previous trial's three 6-week cycles, FLASH2 will implement 18 weeks of continuous treatment in a randomized, double-blind, placebo-controlled setting. A formal interim analysis is expected in early 2026.
Soligenix announced positive post-treatment data from their open-label study comparing HyBryte™ to Valchlor® in treating rare diseases. The study, involving 10 patients split equally, showed HyBryte™ achieved 60% treatment response versus 20% for Valchlor® after 12 weeks. Notably, 3 of 5 HyBryte™ patients showed continued improvement even 4 weeks after treatment ended, with one achieving complete response. HyBryte™ demonstrated significant efficacy against plaque lesions (75% response rate vs 17% for Valchlor®) and maintained a better safety profile with no related adverse events, compared to 60% adverse event rate in Valchlor® patients.
Soligenix (NASDAQ: SNGX) announced the formation of a European Medical Advisory Board (MAB) to support its upcoming confirmatory Phase 3 study of HyBryte™ for cutaneous T-cell lymphoma (CTCL). The study, set to begin by end of 2024, will be multicenter, double-blind, and placebo-controlled, enrolling approximately 80 patients in the US and Europe. The trial will span 18 weeks with top-line results expected in H2 2026. The European MAB includes renowned CTCL experts Dr. Martine Bagot (France), Dr. Pietro Quaglino (Italy), and Dr. Pablo Luis Ortiz-Romero (Spain), who will provide strategic guidance on clinical development and regulatory interactions.