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 a late-stage biopharmaceutical company headquartered in Princeton, New Jersey. The company is dedicated to developing and commercializing products that address unmet medical needs, particularly in the areas of inflammation, oncology, and biodefense. Soligenix operates through two business segments: Specialized BioTherapeutics and Public Health Solutions.
Under the Specialized BioTherapeutics segment, Soligenix focuses on rare disease treatments. Key projects include HyBryte™ (SGX301), a novel photodynamic therapy using synthetic hypericin for cutaneous T-cell lymphoma (CTCL). HyBryte™ has shown promising results in Phase 3 clinical trials and is on track for regulatory approvals in the United States and Europe. Other development programs include SGX302 for psoriasis, SGX942 for oral mucositis in head and neck cancer, and SGX945 for Behçet's disease.
The Public Health Solutions segment emphasizes vaccine development and biodefense. Notable projects include RiVax®, a ricin toxin vaccine candidate, and thermostable vaccine candidates for filoviruses such as Marburg and Ebola. These vaccines are developed using the company's proprietary heat stabilization platform technology, ThermoVax®. Soligenix has also been active in developing CiVax™, a vaccine candidate for COVID-19.
Recent achievements include additional patents for their trivalent filovirus vaccine platform and positive clinical trial results for HyBryte™. Financially, the company reported a net loss for the quarter ended March 31, 2024, but successfully raised $4.75 million through a public offering. Soligenix has also secured significant non-dilutive government funding to support its various development programs.
Partnerships with esteemed institutions like the University of Hawaiʽi at Mānoa and funding from organizations such as the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) further bolster Soligenix's research and development efforts. With a robust pipeline and strategic collaborations, Soligenix aims to deliver significant long-term value to its shareholders and address critical healthcare needs globally.
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.
Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in the upcoming Q4 Investor Summit on November 21st. The company will deliver a presentation from 12:00 PM to 12:30 PM ET and will be available for one-on-one meetings throughout the event.
The summit will showcase 40 micro-cap companies with catalysts and/or strong market performance. The virtual event features live Q&A sessions and is complimentary for qualified investors, with presentations accessible via webcast.
Soligenix (SNGX) has initiated patient enrollment for a Phase 2 clinical trial evaluating SGX945 (dusquetide) in treating Behçet's Disease. The study received clearance from both FDA and Turkish authorities. The open-label trial will enroll approximately 25 patients with mild to moderate Behçet's Disease and active oral/genital ulcers. Patients will receive twice-weekly IV infusions for 4 weeks, followed by 4 weeks of follow-up. The company expects to announce results in the first half of 2025. The disease affects up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and about 1 million worldwide.
Soligenix (NASDAQ: SNGX) reported its Q3 2024 financial results and recent accomplishments. The company ended the quarter with $9.8 million in cash and reported a net loss of $1.7 million ($0.78 per share). Key developments include preparations for a confirmatory Phase 3 study of HyBryte™ for CTCL treatment and an upcoming Phase 2 study for SGX945 in Behçet's disease. The company secured patents in Hong Kong and Europe for synthetic hypericin production and established a partnership with Sterling Pharma Solutions. Research and development expenses increased to $1.0 million from $0.8 million year-over-year, while general and administrative expenses decreased to $0.9 million from $1.0 million.
Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company focusing on rare disease treatments, has announced its participation in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. Jonathan Guarino, Senior VP and CFO, will present at 9:00 AM ET. The conference brings together institutional investors, corporate clients, and industry professionals to showcase innovations and financial strategies. Company management will be available for one-on-one investor meetings throughout the day.
Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company focusing on rare diseases with unmet medical needs, has announced its participation in three upcoming investor conferences. The company will provide corporate updates at the following events:
- 2024 Maxim Healthcare Virtual Summit on October 17, 2024
- ThinkEquity Conference on October 30, 2024
- Spartan Capital Investor Conference 2024 on November 4, 2024
Key members of Soligenix management will be available for one-on-one meetings during these conferences. Investors unable to attend can schedule meetings by contacting ir@soligenix.com. For more information on each conference, interested parties can visit the respective conference websites provided in the announcement.
Soligenix (Nasdaq: SNGX) announced that two lead investigators will present findings from additional supportive trials of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL) at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland on October 9-11, 2024.
Dr. Ellen Kim will present a poster with expanded preliminary results from an investigator-initiated study (RW-HPN-MF-01) at the University of Pennsylvania. Dr. Brian Poligone will give an oral presentation on results from two expanded treatment studies (HPN-CTCL-02 and HPN-CTCL-04) conducted at the Rochester Skin Lymphoma Medical Group.
These presentations will elaborate on findings demonstrating the utility of longer treatment times, the lack of significant systemic exposure to hypericin after topical application, and its relative efficacy and tolerability compared to Valchlor®.
Soligenix (Nasdaq: SNGX) has announced a partnership with Sterling Pharma Solutions to optimize and implement commercially viable, scalable production technology for synthetic hypericin. This active ingredient is used in Soligenix's topical drug product formulations HyBryte™ and SGX302, which are being developed to treat cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively.
The collaboration aims to transfer and optimize manufacturing processes and analytics for GMP manufacturing for clinical trials, with the intention of establishing a long-term commercial manufacturing partnership. This partnership is expected to help Soligenix expand its synthetic hypericin manufacturing capabilities, scale up the process, and reduce costs of goods.
The partnership will support the advancement of Soligenix's topical hypericin clinical programs, particularly HyBryte™ for early-stage CTCL treatment, towards potential worldwide commercialization.
FAQ
What is the current stock price of Soligenix (SNGX)?
What is the market cap of Soligenix (SNGX)?
What does Soligenix, Inc. specialize in?
What are the key projects under Soligenix's Specialized BioTherapeutics segment?
What is ThermoVax®?
What achievements has Soligenix recently made?
Who are some of Soligenix's key partners?
What financial milestones has Soligenix achieved?
What is HyBryte™?
What is CiVax™?
What is RiVax®?
What are Soligenix's key areas of focus in vaccine development?
