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. (NASDAQ: SNGX) announced the publication of positive results from its Phase 3 FLASH study of HyBryte™ in the treatment of cutaneous T-cell lymphoma (CTCL) in JAMA Dermatology. The study demonstrated a statistically significant reduction in lesion size, with 49% of patients achieving a response after 18 weeks of treatment. HyBryte™ showed strong efficacy and safety, addressing the critical need for effective treatments in CTCL. The results highlight the potential of HyBryte™ to set a new standard in CTCL therapy, indicating promising next steps for regulatory approval.
Soligenix, Inc. (Nasdaq: SNGX) announced FDA clearance of its IND application for a Phase 2a clinical trial of SGX302, targeting mild-to-moderate psoriasis. The trial aims to assess the safety and efficacy of topically-applied synthetic hypericin, with patient enrollment expected in Q4 2022. Previously, synthetic hypericin showed promising results in a Phase 1/2 trial for psoriasis. The global psoriasis market is projected to grow from $15 billion in 2020 to $40 billion by 2027, highlighting the potential impact of successful results from this trial.
Soligenix, Inc. (SNGX) announced a significant milestone: their bivalent vaccine demonstrated 100% protection in non-human primates against lethal Marburg and Sudan viruses. This subunit vaccine, developed in collaboration with the University of Hawaiʻi, features a thermostabilized formulation that can be stored at higher temperatures, enhancing public health response capabilities. The vaccine platform also shows promise for future health emergencies, including potential pandemic scenarios. Supported by NIH funding, the program continues to advance toward commercialization.
Soligenix, Inc. (Nasdaq: SNGX) announced a publication in the Journal Structure detailing the binding of its Innate Defense Regulator (IDR), dusquetide, to the p62 protein. Dusquetide shows anti-infective, anti-tumor, and anti-inflammatory properties, having reduced severe oral mucositis (SOM) rates in clinical trials. The Phase 3 study demonstrated significant results for its primary endpoint, supporting dusquetide's potential for HNC treatment. With a strong intellectual property position and ongoing research, Soligenix is exploring product opportunities for dusquetide and its analogs.
Soligenix, Inc. (Nasdaq: SNGX) announced a Notice of Allowance from the USPTO for its patent application on thermally stable trivalent filovirus vaccines. The vaccine platform combines glycoprotein antigens with nanoemulsion adjuvants, demonstrating efficacy against Ebola and Marburg viruses. It shows stable performance at high temperatures, enhancing storage logistics for vaccine distribution in outbreak scenarios. The vaccine candidate has exhibited protection in non-human primates, and the project is supported by NIH grants.
Soligenix, a late-stage biopharmaceutical company focusing on rare diseases, will present at the H.C. Wainwright Global Investment Conference from May 23 to 26, 2022. Their on-demand presentation is scheduled for May 24 at 7 AM ET. Attendees can schedule one-on-one meetings with Soligenix management during the event. The company is advancing the commercialization of HyBryte™ (SGX301) for cutaneous T-cell lymphoma and developing other therapeutics for various conditions. For more information, visit their website or the conference site.
Soligenix, Inc. (Nasdaq: SNGX) reported its financial results for Q1 2022, with revenues of $0.2 million, up from $0.1 million in Q1 2021. The company incurred a net loss of $4.3 million, increasing from $2.4 million in the previous year. Key upcoming milestones include submitting a New Drug Application for HyBryte™ for cutaneous T-cell lymphoma and initiating a Phase 2a trial for SGX302 in psoriasis. With $22.9 million in cash and government funding support, Soligenix is positioned to advance its product development strategies.
Soligenix, Inc. (Nasdaq: SNGX) announced it has secured approximately $1.4 million in non-dilutive funding through government tax programs. This includes $1.2 million from New Jersey's Technology Business Tax Certificate Transfer Program and $0.2 million from the UK's HMRC R&D Tax Credit Program. Over the past twelve years, Soligenix has received about $7.6 million in non-dilutive funding, supporting its rare disease pipeline. They plan to file a new drug application for HyBryte™, treating cutaneous T-cell lymphoma, later this year.
Soligenix, Inc. (SNGX) reported its financial results for the year ended December 31, 2021, revealing revenues of $0.8 million, down from $2.4 million in 2020. The net loss decreased to $12.6 million ($0.31 per share) from $17.7 million ($0.64 per share) in 2020. Key developments include plans to submit an NDA for HyBryte™ for cutaneous T-cell lymphoma and initiate a Phase 2a trial for SGX302 in psoriasis. Cash reserves stood at $23.3 million, sufficient to support upcoming milestones. The company remains open to strategic partnerships and acquisitions.
Soligenix, Inc. (Nasdaq: SNGX) announced positive results from a study of its CiVax™ COVID-19 booster vaccine in non-human primates. Administered seven months post-primary vaccination, the booster rapidly enhanced neutralizing antibody responses against the Delta and Omicron variants. Antibody levels increased by up to 27-fold within a week and 243-fold within three weeks. CiVax™, supported by a $1.5M SBIR grant from NIAID, showcases broad potential due to its heat-stable formulation, which could simplify global vaccination logistics.
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