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 (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.
Soligenix, Inc. (Nasdaq: SNGX) announced FDA clearance of its IND application for a Phase 2a clinical trial of SGX302, targeting mild-to-moderate psoriasis. The trial aims to assess the safety and efficacy of topically-applied synthetic hypericin, with patient enrollment expected in Q4 2022. Previously, synthetic hypericin showed promising results in a Phase 1/2 trial for psoriasis. The global psoriasis market is projected to grow from $15 billion in 2020 to $40 billion by 2027, highlighting the potential impact of successful results from this trial.
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