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) 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.
Soligenix (Nasdaq: SNGX) has received conditional acceptance from the U.S. FDA for the brand name HyBryte™ for its novel treatment SGX301, intended for early-stage cutaneous T-cell lymphoma (CTCL). This milestone supports Soligenix's goal of U.S. commercialization, with plans to submit a rolling new drug application in Q2 2021. SGX301 has been designated as an Orphan Drug and received Fast Track designations from the FDA, emphasizing its potential impact on patients with this rare disease.
Soligenix, Inc. (Nasdaq: SNGX) reported its 2020 financial results, revealing revenues of $2.4 million, down from $4.6 million in 2019. The company experienced a net loss of $17.7 million, a significant increase due to high R&D costs related to its Phase 3 clinical trials for SGX301 and SGX942. Soligenix successfully completed the Phase 3 FLASH trial for SGX301, paving the way for a rolling NDA submission in 2Q 2021. With over $30 million in cash and non-dilutive funding, the firm is poised for growth, targeting over $90 million in U.S. annual net sales for SGX301, amid partnerships for expanding its market reach.
Soligenix, Inc. (Nasdaq: SNGX) announced preliminary approval for a tax credit from the New Jersey Economic Development Authority, allowing the transfer of approximately $865,000 in net proceeds. This program enables biotechnology firms to convert unused Net Operating Loss Carryovers and R&D Tax Credits into cash. Over 11 years, Soligenix has received about $6.5 million in such funding, supporting its rare disease pipeline. The company is preparing to submit a rolling NDA for SGX301, its first-in-class therapy for cutaneous T-cell lymphoma, projected to achieve annual sales exceeding $90 million.
Soligenix, Inc. (Nasdaq: SNGX) announced positive progress in pre-clinical studies for its COVID-19 vaccine candidate, CiVax™, highlighting confirmed broad-spectrum immunity through its full-length Spike protein antigens. Research published on bioRxiv shows the vaccine's potential for rapid distribution without cold chain requirements, supported by a $1.5M SBIR grant. Collaborative efforts with the University of Hawaiʻi aim to evaluate immunogenicity in future non-human primate models while addressing logistical challenges in global vaccine distribution.
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