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, Inc. (SNGX) announced a pivotal Phase 3 trial (FLASH) for its drug HyBryte™ in cutaneous T-cell lymphoma (CTCL) will be presented at the US Cutaneous Lymphoma Consortium Annual Meeting on June 26, 2021. The FLASH trial, the largest of its kind, involved 169 patients and demonstrated significant efficacy, with 16% of HyBryte™ patients achieving at least a 50% reduction in lesions compared to 4% for placebo (p=0.04). HyBryte™ is noted for its safety profile, having received FDA orphan drug and fast track designations.
Soligenix, Inc. (SNGX) announced a significant regulatory milestone, receiving a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency for HyBryte™ (SGX301), used for treating cutaneous T-cell lymphoma (CTCL). The waiver allows Soligenix to pursue marketing authorization applications without conducting pediatric studies, thus saving time and resources. The company plans to focus on the U.S. market first, followed by Europe. This achievement is pivotal for advancing its commercialization efforts.
Soligenix, Inc. (Nasdaq: SNGX) announced it secured approximately $865,000 in non-dilutive financing through the New Jersey Technology Business Tax Certificate Transfer Program. This funding is part of the company's ongoing strategy to leverage Net Operating Loss (NOL) funding, accumulating about $6.5 million over eleven years. The program allows biotechnology firms to convert unused tax benefits into cash, aiding in R&D and operational costs. Soligenix is advancing its rare disease pipeline, specifically HyBryte™ for cutaneous T-cell lymphoma treatment, while pursuing regulatory approval.
Soligenix, Inc. (SNGX) announced that the Japan Patent Office granted a patent for unique methods to produce synthetic hypericin, the active ingredient in its photodynamic therapy, HyBryte™. This patent complements previous approvals in the U.S. and enhances the company's intellectual property portfolio. HyBryte™ has shown positive results in the pivotal Phase 3 FLASH trial for cutaneous T-cell lymphoma (CTCL), achieving a statistically significant treatment response. The company is advancing towards regulatory approval and commercialization in the U.S., exploring partnerships for international markets.
Soligenix, Inc. (SNGX) reported its Q1 2021 financial results, revealing revenues of $0.1 million, a decline from $0.9 million in Q1 2020. The company’s basic net loss improved to $2.4 million, or ($0.06) per share, compared to $7.6 million, or ($0.32) per share, the previous year. Key achievements include FDA conditional acceptance for HyBryte™ and advancements in its COVID-19 vaccine, CiVax™, which showed promising results in preclinical trials. With approximately $30 million in cash, Soligenix is positioned to pursue multiple critical milestones.
Soligenix, Inc. (SNGX) announced that its product HyBryte™ has received an "Innovation Passport" from the UK's Innovative Licensing and Access Pathway (ILAP) for treating early-stage cutaneous T-cell lymphoma (CTCL) in adults. This designation initiates an accelerated development process, allowing earlier patient access. HyBryte™ is a photodynamic therapy that utilizes synthetic hypericin and visible light, showing significant efficacy in clinical trials. The company aims to engage with regulatory bodies to expedite HyBryte's availability to patients in the UK.
On May 4, 2021, Soligenix (Nasdaq: SNGX) announced positive results from the Phase 3 FLASH study concerning HyBryte™ (SGX301) for treating cutaneous T-cell lymphoma (CTCL). During the Society for Investigative Dermatology meeting, data revealed that 49% of patients achieved a significant reduction in lesions after 18 weeks. HyBryte™ demonstrated fewer severe side effects than current therapies and showed a low 5% drop-out rate due to adverse events. The study marked the largest of its kind, suggesting HyBryte™ could fulfill a critical need for safer CTCL treatments.
Soligenix, Inc. (Nasdaq: SNGX) announced a successful presentation on its CiVax™ COVID-19 vaccine program at the Annual Conference on Vaccinology Research on April 26-27, 2021. The presentation highlighted the vaccine's potent immunogenicity in mice and non-human primates, utilizing heat-stabilization technology and the CoVaccine HT™ adjuvant, which allows for dose-sparing and ambient temperature storage. This innovative approach may facilitate rapid global vaccine distribution. The project is supported by a grant from the National Institutes of Health.
Soligenix, Inc. (Nasdaq: SNGX) announced expanded data on its photodynamic therapy HyBryte™ (SGX301) for cutaneous T-cell lymphoma (CTCL) during the American Academy of Dermatology meeting. The Phase 3 FLASH study showed a 40% treatment response after 12 weeks and 49% after 18 weeks, with serious adverse events at just 2.4%. HyBryte™ demonstrated significant efficacy with a non-mutagenic mechanism, avoiding long-term actinic skin damage. This pivotal trial is the largest of its kind for CTCL, indicating potential as a safer front-line therapy compared to existing treatments. Regulatory approval is being sought for commercial launch.
Soligenix, Inc. (Nasdaq: SNGX) announced planned presentations at upcoming conferences showcasing their innovative therapies. The focus will be on HyBryte™ (SGX301), a treatment for cutaneous T-cell lymphoma (CTCL), highlighting results from the Phase 3 FLASH study, and updates on their CiVax™ COVID-19 vaccine program. HyBryte™ has shown significant efficacy, with a 16% reduction in lesions during the first treatment cycle, compared to 4% in placebo. HyBryte™ is a first-in-class therapy using synthetic hypericin with no systemic absorption, aiming for regulatory approval in the U.S.
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?
