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 repeatedly described in its public communications as a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. News about SNGX often centers on progress across its two segments, Specialized BioTherapeutics and Public Health Solutions, and provides updates on clinical trials, regulatory designations, advisory boards and financing activities.
In the Specialized BioTherapeutics segment, recent press releases highlight the ongoing confirmatory Phase 3 FLASH2 study of HyBryte™ (SGX301, synthetic hypericin sodium) for cutaneous T-cell lymphoma (CTCL), including enrollment milestones and interim safety reviews. Additional news covers Phase 2a clinical results for SGX302 in mild-to-moderate psoriasis, emphasizing improvements in standard psoriasis indices with synthetic hypericin-based photodynamic therapy, and publications and regulatory designations for SGX945 (dusquetide) in Behçet's Disease, including orphan drug designation from the FDA.
Coverage of Soligenix also includes updates on its innate defense regulator (IDR) technology platform, describing dusquetide’s role in modulating the innate immune response, and on its Public Health Solutions programs such as the RiVax® ricin toxin vaccine candidate, filovirus vaccines and CiVax™ for COVID-19, which use the ThermoVax® heat-stabilization platform and have received support from agencies like NIAID, DTRA and BARDA.
Investors following SNGX news can expect announcements about clinical trial milestones, peer-reviewed publications, FDA orphan and fast track designations, medical advisory board expansions in CTCL, as well as capital markets events such as public offerings and Nasdaq listing compliance updates. Bookmarking the SNGX news page on Stock Titan can help track these developments in one place as the company advances its rare-disease and biodefense pipeline.
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.
Soligenix, Inc. (Nasdaq: SNGX) has further adjourned its 2022 Annual Meeting of Stockholders to November 17, 2022, at 9:00 a.m. Eastern Time, focusing on Proposal 2 regarding the authorized share increase. Support for this proposal has surpassed 80% of votes cast, but requires over 50% of total outstanding shares for approval. Stockholders record date is July 25, 2022. Soligenix is advancing toward filing a new drug application for its product HyBryte™ in Q4, considering additional shares necessary for talent acquisition and future financing.
Soligenix, Inc. announced the partial adjournment of its 2022 Annual Meeting of Stockholders, originally held on September 22, 2022, to solicit additional votes for Proposal 2: increasing authorized shares from 75 million to 125 million. The reconvened meeting is scheduled for October 19, 2022. The Board believes that increasing shares is crucial for efficient operations, especially as the company progresses towards filing a new drug application for HyBryte™. Stockholders are encouraged to vote by October 18, 2022, to influence the outcome of the proposal.