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 that its product HyBryte™ has received an "Innovation Passport" from the UK's Innovative Licensing and Access Pathway (ILAP) for treating early-stage cutaneous T-cell lymphoma (CTCL) in adults. This designation initiates an accelerated development process, allowing earlier patient access. HyBryte™ is a photodynamic therapy that utilizes synthetic hypericin and visible light, showing significant efficacy in clinical trials. The company aims to engage with regulatory bodies to expedite HyBryte's availability to patients in the UK.
On May 4, 2021, Soligenix (Nasdaq: SNGX) announced positive results from the Phase 3 FLASH study concerning HyBryte™ (SGX301) for treating cutaneous T-cell lymphoma (CTCL). During the Society for Investigative Dermatology meeting, data revealed that 49% of patients achieved a significant reduction in lesions after 18 weeks. HyBryte™ demonstrated fewer severe side effects than current therapies and showed a low 5% drop-out rate due to adverse events. The study marked the largest of its kind, suggesting HyBryte™ could fulfill a critical need for safer CTCL treatments.
Soligenix, Inc. (Nasdaq: SNGX) announced a successful presentation on its CiVax™ COVID-19 vaccine program at the Annual Conference on Vaccinology Research on April 26-27, 2021. The presentation highlighted the vaccine's potent immunogenicity in mice and non-human primates, utilizing heat-stabilization technology and the CoVaccine HT™ adjuvant, which allows for dose-sparing and ambient temperature storage. This innovative approach may facilitate rapid global vaccine distribution. The project is supported by a grant from the National Institutes of Health.
Soligenix, Inc. (Nasdaq: SNGX) announced expanded data on its photodynamic therapy HyBryte™ (SGX301) for cutaneous T-cell lymphoma (CTCL) during the American Academy of Dermatology meeting. The Phase 3 FLASH study showed a 40% treatment response after 12 weeks and 49% after 18 weeks, with serious adverse events at just 2.4%. HyBryte™ demonstrated significant efficacy with a non-mutagenic mechanism, avoiding long-term actinic skin damage. This pivotal trial is the largest of its kind for CTCL, indicating potential as a safer front-line therapy compared to existing treatments. Regulatory approval is being sought for commercial launch.
Soligenix, Inc. (Nasdaq: SNGX) announced planned presentations at upcoming conferences showcasing their innovative therapies. The focus will be on HyBryte™ (SGX301), a treatment for cutaneous T-cell lymphoma (CTCL), highlighting results from the Phase 3 FLASH study, and updates on their CiVax™ COVID-19 vaccine program. HyBryte™ has shown significant efficacy, with a 16% reduction in lesions during the first treatment cycle, compared to 4% in placebo. HyBryte™ is a first-in-class therapy using synthetic hypericin with no systemic absorption, aiming for regulatory approval in the U.S.
Soligenix (Nasdaq: SNGX) has received conditional acceptance from the U.S. FDA for the brand name HyBryte™ for its novel treatment SGX301, intended for early-stage cutaneous T-cell lymphoma (CTCL). This milestone supports Soligenix's goal of U.S. commercialization, with plans to submit a rolling new drug application in Q2 2021. SGX301 has been designated as an Orphan Drug and received Fast Track designations from the FDA, emphasizing its potential impact on patients with this rare disease.
Soligenix, Inc. (Nasdaq: SNGX) reported its 2020 financial results, revealing revenues of $2.4 million, down from $4.6 million in 2019. The company experienced a net loss of $17.7 million, a significant increase due to high R&D costs related to its Phase 3 clinical trials for SGX301 and SGX942. Soligenix successfully completed the Phase 3 FLASH trial for SGX301, paving the way for a rolling NDA submission in 2Q 2021. With over $30 million in cash and non-dilutive funding, the firm is poised for growth, targeting over $90 million in U.S. annual net sales for SGX301, amid partnerships for expanding its market reach.
Soligenix, Inc. (Nasdaq: SNGX) announced preliminary approval for a tax credit from the New Jersey Economic Development Authority, allowing the transfer of approximately $865,000 in net proceeds. This program enables biotechnology firms to convert unused Net Operating Loss Carryovers and R&D Tax Credits into cash. Over 11 years, Soligenix has received about $6.5 million in such funding, supporting its rare disease pipeline. The company is preparing to submit a rolling NDA for SGX301, its first-in-class therapy for cutaneous T-cell lymphoma, projected to achieve annual sales exceeding $90 million.
Soligenix, Inc. (Nasdaq: SNGX) announced positive progress in pre-clinical studies for its COVID-19 vaccine candidate, CiVax™, highlighting confirmed broad-spectrum immunity through its full-length Spike protein antigens. Research published on bioRxiv shows the vaccine's potential for rapid distribution without cold chain requirements, supported by a $1.5M SBIR grant. Collaborative efforts with the University of Hawaiʻi aim to evaluate immunogenicity in future non-human primate models while addressing logistical challenges in global vaccine distribution.
Soligenix, Inc. (SNGX) provided a corporate update highlighting a positive Phase 3 study of SGX301 for cutaneous T-cell lymphoma, with plans for a new drug application (NDA) submission. The company also reported promising preclinical results for its heat-stable COVID-19 vaccine candidate, CiVax™, while maintaining a strong cash position of over $30 million to support growth. Notably, SGX301's U.S. peak annual sales could exceed $90 million. However, disappointing results from SGX942's Phase 3 trial for oral mucositis raised concerns, as it did not meet statistical significance despite showing biological activity.
