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 the positive outcome of its pivotal Phase 3 FLASH study, validating the efficacy of synthetic hypericin for cutaneous T-cell lymphoma (CTCL). Following this, the company aims to expand the use of synthetic hypericin, also known as SGX302, into the treatment of psoriasis, a chronic skin condition affecting millions. The treatment utilizes visible light activation, minimizing long-term risks associated with traditional therapies. With promising results from earlier studies, Soligenix plans to initiate a Phase 2a trial for psoriasis in late 2022, without needing to raise additional capital.
Soligenix announced that the FDA has granted orphan drug designation to hypericin for the treatment of T-cell lymphoma, expanding its application beyond cutaneous T-cell lymphoma (CTCL). This designation offers significant benefits, including a seven-year market exclusivity and various financial incentives for clinical trials. The company aims to file a New Drug Application in the first half of 2022, supported by positive Phase 3 trial results demonstrating efficacy and safety of its product, HyBryte (SGX301), in treating CTCL.
Soligenix (Nasdaq:SNGX) has released promising preclinical data on its thermostable vaccine platform, aimed at addressing challenges in vaccine storage, especially in developing countries. Key findings include successful formulation and heat stabilization of vaccines, with efficacy demonstrated in non-human primates for both monovalent and bivalent formulations. The company has a current cash position of approximately $29 million, enabling it to pursue strategic goals and advance its pipeline. This progress positions Soligenix as a contributor to future health emergencies.
Soligenix, Inc. (Nasdaq: SNGX) announced a publication detailing its single-vial platform for filovirus vaccines, including monovalent, bivalent, and trivalent combinations. Collaborating with the University of Hawaiʻi at Mānoa and the University of Colorado, the study illustrates the stability of these vaccines when stored at high temperatures. Notably, a trivalent formulation protected 75% of vaccinated non-human primates against Sudan ebolavirus. This platform's practicality could enhance responses to outbreaks and facilitate rapid vaccination efforts in emergencies.
On August 18, 2021, Soligenix (SNGX) announced promising preclinical results for its filovirus vaccine candidates, demonstrating protective efficacy against Zaire ebolavirus, Sudan ebolavirus, and Marburg virus in non-human primates. Collaborators from the University of Hawaiʻi showcased the effectiveness of a thermostabilized multivalent vaccine that achieved 75% protection against Sudan ebolavirus. This groundbreaking research highlights the potential for broadly applicable vaccines and aims to address health emergencies linked to filovirus outbreaks, with further development anticipated.
Soligenix, Inc. (Nasdaq: SNGX) announced its financial results for the second quarter of 2021, reporting revenues of $0.2 million compared to $0.5 million in Q2 2020. The net loss decreased to $1.9 million, or ($0.05) per share, attributed to a Paycheck Protection Program loan forgiveness. The company holds approximately $29 million in cash, with plans for U.S. commercialization of its drug HyBryte™ for cutaneous T-cell lymphoma, projecting peak annual net sales to exceed $90 million. Recent regulatory achievements include a Pediatric Investigation Plan waiver from the EMA.
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.
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