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. reports developments as a late-stage biopharmaceutical company focused on rare diseases and public health medical countermeasures. Company news centers on HyBryte (synthetic hypericin), a visible-light activated therapy program for cutaneous T-cell lymphoma, and SGX945 (dusquetide) for Behçet's Disease, including clinical data, published study results and regulatory designations.
Updates also cover the Public Health Solutions segment, including RiVax ricin toxin vaccine candidate, filovirus vaccine programs, CiVax for COVID-19 and the ThermoVax heat-stabilization platform. Recurring announcements include operating and financial results, government-supported development activities, material agreements, shareholder voting matters and governance updates.
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.
Soligenix, Inc. (Nasdaq: SNGX) announced FDA approval of its initial pediatric study plan for HyBryte™ intended for treating cutaneous T-cell lymphoma (CTCL). The company plans to request a full waiver of pediatric studies when submitting its new drug application (NDA) later this year. This agreement is a vital regulatory step toward commercialization. HyBryte™ is a novel photodynamic therapy utilizing synthetic hypericin, with a completed Phase 3 trial showing promising results against CTCL. Safety and efficacy profiles are favorable, positioning HyBryte™ as a potential front-line treatment.
Soligenix, Inc. (SNGX) has announced a strategic partnership with SERB Pharmaceuticals to exclusively license its ricin antigen for the development of a therapeutic treatment against ricin poisoning. This partnership aims to address a significant unmet medical need, as there are currently no therapeutic options available for ricin toxin exposure. Furthermore, Soligenix is advancing its own ricin vaccine, RiVax®, supported by over $30 million in government funding. The specific terms of the licensing agreement remain undisclosed.
Soligenix, Inc. (NASDAQ: SNGX) announced the publication of positive results from its Phase 3 FLASH study of HyBryte™ in the treatment of cutaneous T-cell lymphoma (CTCL) in JAMA Dermatology. The study demonstrated a statistically significant reduction in lesion size, with 49% of patients achieving a response after 18 weeks of treatment. HyBryte™ showed strong efficacy and safety, addressing the critical need for effective treatments in CTCL. The results highlight the potential of HyBryte™ to set a new standard in CTCL therapy, indicating promising next steps for regulatory approval.