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 (SNGX) is a biopharmaceutical innovator developing therapies for rare diseases and biodefense solutions. This page provides official updates on clinical trials, regulatory milestones, and scientific advancements across its two core segments: specialized therapeutics for conditions like cutaneous T-cell lymphoma (CTCL) and public health vaccines for biological threats.
Investors and researchers will find timely announcements about HyBryte™ photodynamic therapy progress, ThermoVax® platform developments, and partnership updates. Content spans trial results, FDA designations, manufacturing collaborations, and research publications – all essential for understanding SNGX's position in niche therapeutic markets.
Bookmark this page for structured access to Soligenix's verified news, organized to help stakeholders monitor advancements in orphan drug candidates and heat-stable vaccine technologies. Regular updates ensure you stay informed about this innovator's progress in addressing high-need, low-competition medical challenges.
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.
Soligenix (SNGX) announced the formation of a Medical Advisory Board (MAB) to guide the Phase 2a clinical trial of SGX302 for treating mild-to-moderate psoriasis, set to start in December 2022. The MAB, comprised of dermatology experts, aims to enhance clinical strategy and regulatory interactions. The FDA previously cleared the investigational new drug application for this trial. SGX302 leverages synthetic hypericin, which has shown efficacy in related conditions, suggesting potential benefits for psoriasis patients, a demographic exceeding 7.5 million in the U.S.
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