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Soligenix, Inc. - SNGX STOCK NEWS

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.

News

FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection

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Soligenix, Inc. receives FDA orphan drug designation for MarVax™ heat stable vaccine against Marburg marburgvirus infection, providing market exclusivity and financial benefits.
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FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Sudan Ebolavirus Infection

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Soligenix, Inc. receives orphan drug designation from the FDA for SuVax™ Heat Stable Vaccine, providing seven years of market exclusivity upon approval. The vaccine targets Sudan ebolavirus, offering potential prevention and post-exposure prophylaxis. Soligenix's novel vaccine platform shows promise in addressing rare diseases with unmet medical needs.
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Soligenix Announces Agreement on the Design of a Second Confirmatory Placebo-Controlled Trial for HyBryte™ With the European Medicines Agency

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Soligenix, Inc. announces agreement from the European Medicines Agency for a Phase 3 study on HyBryte™ in treating cutaneous T-cell lymphoma. The 18-week study aims to replicate and extend results from a previous successful study, with top-line results expected in the second half of 2026.
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Soligenix Announces Recent Accomplishments and Year End 2023 Financial Results

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Soligenix, Inc. (SNGX) reports its financial results for the year ended December 31, 2023, highlighting advancements in clinical programs, FDA discussions, and successful trial results. The company's revenue was $0.8 million, with a net loss of $6.1 million. Soligenix maintains a cash position of $8.4 million, focusing on managing cash burn and exploring strategic options.
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Soligenix Announces Formation of Behçet's Disease Medical Advisory Board

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Soligenix, Inc. announces the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to aid in the clinical development of SGX945 (dusquetide) for the treatment of Behçet's Disease. The MAB will be comprised of internationally renowned rheumatologists with extensive experience in Behçet's Disease. The Phase 2a clinical study of SGX945 in Behçet's Disease is set to initiate in 2024.
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Soligenix and Mobilicom Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV

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Soligenix, Inc. (NASDAQ:SNGX) and Mobilicom Limited (NASDAQ:MOB) will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV. Soligenix, a late-stage biopharmaceutical company, has made significant advancements in its product pipeline, with its lead clinical asset, HyBryte™ or SGX301, showing positive results in a Phase 3 study. The company is also progressing with SGX302 for psoriasis and SGX203 for pediatric Crohn's disease. Additionally, Soligenix has achieved milestones in public health solutions, including promising data from its filovirus vaccine program. Mobilicom presents a strong investment opportunity with its comprehensive and proprietary technology suite, global footprint, and recent milestones in defense deals. The company is financially robust and poised to shift its revenue focus from hardware to Software-as-a-Service (SaaS) and recurring cybersecurity revenues from 2024.
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Soligenix to Present at The Microcap Conference

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Soligenix, Inc. (Nasdaq: SNGX) will present at The Microcap Conference in Atlantic City, N.J., focusing on developing and commercializing products to treat rare diseases with unmet medical needs.
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FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

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Soligenix, Inc. (Nasdaq: SNGX) has received 'Fast Track' designation from the FDA for its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease. This designation allows for an expedited review process and potential NDA submission on a rolling basis, with priority review eligibility, indicating a significant milestone for the company's biopharmaceutical development efforts.
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Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis

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Soligenix, Inc. (Nasdaq: SNGX) announced preliminary top-line results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. The expanded portion of the trial (Cohort 2) showed clinical success in patients, with two reaching an 'Almost Clear' disease status, and a mean drop of approximately 50% in the Psoriasis Activity and Severity Index (PASI) score. The company plans to pursue SGX302 in psoriasis treatment and explore other disease indications, including non-orphan indications, where there remains an unmet medical need.
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Soligenix Announces Publication Demonstrating Complete Protection Against Filovirus Disease in Nonhuman Primate Models of Ebola and Marburg Viruses

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Soligenix, Inc. (Nasdaq: SNGX) announced the publication of a preclinical study on a single-vial thermostabilized bivalent vaccine providing 100% protection against Sudan ebolavirus and Marburg marburgvirus infections. The vaccine candidate has demonstrated stability to high temperature storage for at least 2 years at 40 degrees Celsius. This development addresses the unmet medical need for rare diseases and has potential public health implications.
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FAQ

What is the current stock price of Soligenix (SNGX)?

The current stock price of Soligenix (SNGX) is $2.95 as of December 20, 2024.

What is the market cap of Soligenix (SNGX)?

The market cap of Soligenix (SNGX) is approximately 7.7M.

What does Soligenix, Inc. specialize in?

Soligenix, Inc. specializes in developing and commercializing biopharmaceutical products to address unmet medical needs in inflammation, oncology, and biodefense.

What are the key projects under Soligenix's Specialized BioTherapeutics segment?

Key projects include HyBryte™ for cutaneous T-cell lymphoma (CTCL), SGX302 for psoriasis, SGX942 for oral mucositis in head and neck cancer, and SGX945 for Behçet's disease.

What is ThermoVax®?

ThermoVax® is Soligenix's proprietary heat stabilization platform technology used in the development of thermostable vaccines.

What achievements has Soligenix recently made?

Recent achievements include additional patents for their trivalent filovirus vaccine platform and positive clinical trial results for HyBryte™.

Who are some of Soligenix's key partners?

Key partners include the University of Hawaiʽi at Mānoa and funding organizations like NIAID and BARDA.

What financial milestones has Soligenix achieved?

Soligenix recently raised $4.75 million through a public offering and has secured substantial non-dilutive government funding.

What is HyBryte™?

HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin for the treatment of cutaneous T-cell lymphoma (CTCL).

What is CiVax™?

CiVax™ is Soligenix's vaccine candidate for the prevention of COVID-19.

What is RiVax®?

RiVax® is Soligenix's ricin toxin vaccine candidate developed under its Public Health Solutions segment.

What are Soligenix's key areas of focus in vaccine development?

Soligenix focuses on developing vaccines for filoviruses (including Marburg and Ebola) and COVID-19, using its ThermoVax® technology.

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Soligenix, Inc.

Nasdaq:SNGX

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