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. (Nasdaq: SNGX) announced a new publication confirming that its RiVax® vaccine offers enduring protection against ricin toxin for at least 12 months post-vaccination. The findings were published in mSphere and highlight previous efficacy trials in animals. The vaccine's thermostability could facilitate stockpiling for emergency use. Soligenix intends to pursue FDA approval under the 'Animal Rule,' given the ethical concerns of human trials. The development is backed by over $40 million in non-dilutive funding. RiVax® has received Orphan Drug and Fast Track designations from the FDA.
Soligenix, Inc. (Nasdaq: SNGX) announced that Dr. Oreola Donini, the Chief Scientific Officer, will present key data on the company's thermostable vaccine technology at the 6th International Conference on Vaccines Research and Development from November 1-3, 2021. The presentation will highlight the ricin toxin vaccine RiVax®, and COVID-19 vaccine CiVax™. Notably, RiVax® has shown up to 100% protection against ricin in non-human primates, remaining potent for over 12 months at elevated temperatures. The company's vaccine platforms aim to reduce logistical challenges in pandemic response.
Soligenix, Inc. (Nasdaq: SNGX) announced its poster abstract on HyBryte™ was chosen as a top abstract for presentation at the 2021 NORD Rare Diseases and Orphan Products Breakthrough Summit on October 18-19, 2021. The FLASH trial, which is the largest study for treating cutaneous T-cell lymphoma (CTCL), showed positive Phase 3 results. Key findings include a 16% lesion reduction in the HyBryte™ group versus 4% in the placebo, demonstrating a favorable safety profile. The company continues to advance the regulatory approval process for this innovative photodynamic therapy.
Soligenix, Inc. (Nasdaq: SNGX) has published promising pre-clinical results for its heat-stable COVID-19 vaccine candidate, CiVax™, demonstrating broad-spectrum neutralizing antibodies against various variants including Beta, Gamma, and Delta. Funded by a $1.5M SBIR grant from NIAID, the study shows that CiVax™ elicited durable immune responses in non-human primates and improved protection against viral loads. The vaccine's ambient temperature stability could enhance global vaccination efforts, reducing logistical challenges. CEO Christopher Schaber highlighted potential impacts on pandemic resolution and future vaccine preparedness.
Soligenix, Inc. (Nasdaq: SNGX) announced that CEO Christopher J. Schaber, PhD, will participate in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference on September 29, 2021, at 8:00 AM ET. The event will allow for virtual one-on-one meetings with registered attendees. The company is focused on treating rare diseases with unmet medical needs, including the development of HyBryte™ for cutaneous T-cell lymphoma and vaccine candidates for infectious diseases.
Soligenix, Inc. (SNGX) announced the positive outcome of its pivotal Phase 3 FLASH study, validating the efficacy of synthetic hypericin for cutaneous T-cell lymphoma (CTCL). Following this, the company aims to expand the use of synthetic hypericin, also known as SGX302, into the treatment of psoriasis, a chronic skin condition affecting millions. The treatment utilizes visible light activation, minimizing long-term risks associated with traditional therapies. With promising results from earlier studies, Soligenix plans to initiate a Phase 2a trial for psoriasis in late 2022, without needing to raise additional capital.
Soligenix announced that the FDA has granted orphan drug designation to hypericin for the treatment of T-cell lymphoma, expanding its application beyond cutaneous T-cell lymphoma (CTCL). This designation offers significant benefits, including a seven-year market exclusivity and various financial incentives for clinical trials. The company aims to file a New Drug Application in the first half of 2022, supported by positive Phase 3 trial results demonstrating efficacy and safety of its product, HyBryte (SGX301), in treating CTCL.
Soligenix (Nasdaq:SNGX) has released promising preclinical data on its thermostable vaccine platform, aimed at addressing challenges in vaccine storage, especially in developing countries. Key findings include successful formulation and heat stabilization of vaccines, with efficacy demonstrated in non-human primates for both monovalent and bivalent formulations. The company has a current cash position of approximately $29 million, enabling it to pursue strategic goals and advance its pipeline. This progress positions Soligenix as a contributor to future health emergencies.
Soligenix, Inc. (Nasdaq: SNGX) announced a publication detailing its single-vial platform for filovirus vaccines, including monovalent, bivalent, and trivalent combinations. Collaborating with the University of Hawaiʻi at Mānoa and the University of Colorado, the study illustrates the stability of these vaccines when stored at high temperatures. Notably, a trivalent formulation protected 75% of vaccinated non-human primates against Sudan ebolavirus. This platform's practicality could enhance responses to outbreaks and facilitate rapid vaccination efforts in emergencies.
On August 18, 2021, Soligenix (SNGX) announced promising preclinical results for its filovirus vaccine candidates, demonstrating protective efficacy against Zaire ebolavirus, Sudan ebolavirus, and Marburg virus in non-human primates. Collaborators from the University of Hawaiʻi showcased the effectiveness of a thermostabilized multivalent vaccine that achieved 75% protection against Sudan ebolavirus. This groundbreaking research highlights the potential for broadly applicable vaccines and aims to address health emergencies linked to filovirus outbreaks, with further development anticipated.
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