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 announced it received a Refusal to File (RTF) letter from the FDA regarding its HyBryte™ new drug application for treating cutaneous T-cell lymphoma (CTCL). The FDA stated that the submission was incomplete for substantive review. Soligenix plans to request a Type A meeting with the FDA to address concerns and discuss the resubmission process. HyBryte™, utilizing synthetic hypericin, has previously shown promising results in clinical trials, with 16% of patients achieving significant lesion reduction. The company remains focused on advancing this treatment option despite the setback.
Soligenix, Inc. (NASDAQ: SNGX) announced a reverse stock split, effective February 9, 2023, at a ratio of 1-for-15. This move reduces the outstanding shares from approximately 43.3 million to about 2.9 million, maintaining stockholder percentage interests except for fractional shares. Trading on a split-adjusted basis begins on February 10, 2023. Shareholders approved the split at a special meeting on February 8, granting the Board discretion to set the ratio between 1-for-2 to 1-for-20. The new CUSIP number for the common stock is 834223505. The company is focused on rare disease therapeutics and vaccine development.
Soligenix, a late-stage biopharmaceutical company, will present at the Virtual Investor Summit on January 26, 2023, at 9:00 AM ET. This event highlights 25 micro-cap companies with significant catalysts and performance. Soligenix is recognized for its lead product candidate, HyBryte™, aimed at treating cutaneous T-cell lymphoma, with a new drug application submitted for regulatory approval. The Investor Summit is complimentary for qualified investors, and one-on-one meetings with Soligenix management can be scheduled. For attendance or additional information, visit the summit website.
Soligenix, Inc. (SNGX) announced a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, effective January 4, 2023. Each share of Series D Preferred Stock will vote on a potential reverse stock split and will grant 1,000,000 votes per share. CEO Christopher Schaber highlighted challenges faced due to market conditions and a Nasdaq deficiency letter regarding the minimum bid price. The reverse stock split is considered essential for maintaining Nasdaq listing, potentially enhancing attractiveness for institutional investors.
Soligenix, Inc. (Nasdaq: SNGX) announced the publication of preclinical studies on RiVax®, a heat-stable ricin toxin vaccine. The studies demonstrated statistically significant correlates of protection in non-human primates, essential for advancing FDA approval under the "Animal Rule." RiVax® provided up to 100% protection against lethal ricin exposure, showing stability for over a year at high temperatures. This progress, supported by over $40 million in non-dilutive funding, positions the vaccine favorably for further studies and potential inclusion in the Strategic National Stockpile.
Soligenix, Inc. (Nasdaq: SNGX) announced the opening of patient enrollment for its Phase 2a study (HPN-PSR-01) evaluating SGX302 (synthetic hypericin) for treating mild-to-moderate psoriasis, a condition affecting 7.5 million people in the U.S. and 60-125 million worldwide. The study aims to enroll up to 42 patients, applying the drug twice weekly for 18 weeks. The innovative therapy uses visible light to activate the drug, potentially minimizing risks associated with traditional treatments. Successful preliminary results from previous trials bolster the company's confidence in this approach.
Soligenix, Inc. (SNGX) announced the submission of a New Drug Application (NDA) for HyBryte™ to the FDA for treating early-stage cutaneous T-cell lymphoma (CTCL), a rare cancer affecting over 25,000 patients in the U.S. The estimated worldwide market for HyBryte™ exceeds $250 million. The NDA has received both orphan drug and fast track designations, with potential FDA approval anticipated in the second half of 2023. Results from the Phase 3 FLASH trial showed significant improvement in lesion reduction, emphasizing HyBryte™ as a promising treatment option with a favorable safety profile.
Soligenix, Inc. (SNGX) has received preliminary approval for a tax credit from the New Jersey Economic Development Authority, enabling the company to transfer this credit and gain approximately $1.2 million in net proceeds. This marks the thirteenth consecutive year of receiving Net Operating Loss funding, totaling nearly $9 million to support its rare disease pipeline. Additionally, Soligenix plans to file a new drug application for HyBryte™ for treating cutaneous T-cell lymphoma and initiate a Phase 2a study of SGX302 for psoriasis. The company has over $16 million in cash and aims for peak annual sales exceeding $90 million.
Soligenix, Inc. (Nasdaq: SNGX) reported Q3 2022 financial results and recent accomplishments. They plan to submit a New Drug Application for HyBryte™ for cutaneous T-cell lymphoma. The company received a $2.6 million FDA Orphan Products Development grant to expand treatment studies. Soligenix demonstrated 100% protection in non-human primates against lethal Ebola and Marburg viruses. With approximately $16.9 million in cash, they aim to achieve near-term milestones, exploring strategic options for partnerships and acquisitions.
Soligenix (Nasdaq: SNGX) has been invited by BARDA to submit a contract proposal for developing SuVax™, a vaccine targeting Sudan ebolavirus amid an outbreak in Uganda. The proposal outlines a $25 million program over five years for advancing SuVax™ and MarVax™ through Phase 1 clinical studies. SuVax™ demonstrated 100% protection in a non-human primate model after a 3-dose series. While the contract award is not guaranteed, Soligenix aims to leverage its heat stabilizing technology to enhance vaccine efficacy against filoviruses.
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