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. (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.
Soligenix, a late-stage biopharmaceutical company focused on rare diseases, announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The company will deliver an on-demand corporate presentation available on September 12 at 7 AM ET, accessible for 30 days for registered attendees. Management will also hold one-on-one meetings during the conference. Soligenix's key products include HyBryte™ for cutaneous T-cell lymphoma and several vaccine candidates targeting infectious diseases.
Soligenix, Inc. (Nasdaq: SNGX) announced that the FDA has awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in patients with early-stage cutaneous T-cell lymphoma (CTCL). This grant will facilitate an open-label study designed to enroll approximately 50 patients across six centers. The study aims to assess treatment success based on a defined reduction in lesion severity. The initiative underscores the ongoing unmet medical need for effective CTCL therapies.
Soligenix, Inc. (Nasdaq: SNGX) reported its Q2 2022 financial results with revenues of $0.4 million, up from $0.2 million in Q2 2021. The company achieved key milestones, including FDA agreement on a pediatric study plan for HyBryte™ and IND clearance for a Phase 2a trial in psoriasis. Notably, Soligenix demonstrated 100% protection in non-human primates against lethal Ebola and Marburg viruses using a novel bivalent vaccine. The net loss for the quarter was $2.4 million, compared to $1.9 million in the previous year. The cash position remains strong at $20.2 million, supporting upcoming initiatives.
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