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, 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.
Soligenix, Inc. (Nasdaq: SNGX) announced that its CEO, Christopher J. Schaber, PhD, will present at the BIO CEO & Investor Digital Conference from February 16-18, 2021. The presentation will be available for on-demand viewing starting February 15 at 9:00 AM EST. Soligenix is advancing its drug application for SGX301, a treatment for cutaneous T-cell lymphoma, following a successful Phase 3 study. The conference offers an opportunity for one-on-one meetings with management, focusing on the company's rare disease pipeline and potential partnerships.
Soligenix, Inc. (Nasdaq: SNGX) announced the Hong Kong Registrar of Patents granted a patent for the therapeutic use of synthetic hypericin in treating cutaneous T-cell lymphoma (CTCL). The patent, published on January 29, 2021, enhances Soligenix's patent estate, protecting synthetic hypericin and its therapeutic methods. SGX301, a first-in-class photodynamic therapy, demonstrated a statistically significant treatment response in a pivotal Phase 3 study. CEO Christopher J. Schaber emphasized the potential for marketing approval and commercialization while pursuing global partnership opportunities.
Soligenix (Nasdaq: SNGX) announced an Investor Webcast Event on January 26, 2021, to discuss U.S. commercialization planning for SGX301, a novel photodynamic therapy for early-stage Cutaneous T-Cell Lymphoma (CTCL). SGX301 demonstrated a statistically significant treatment response in the Phase 3 FLASH trial after just 6 weeks (p=0.04) compared to placebo. Continued treatment improved outcomes, with 40% response in the second cycle. SGX301 was well tolerated, showing no mutagenic risks. The event will include insights from leading experts and management.
Soligenix, Inc. (SNGX) has entered an exclusive Supply, Distribution and Services Agreement with Daavlin for the SGX301 light device, aimed at treating cutaneous T-cell lymphoma (CTCL). This partnership is pivotal for the commercialization strategy of SGX301 upon FDA approval. Daavlin, with a 40-year history in phototherapy, will manufacture the device, while Soligenix will promote and facilitate purchases of the product. Both companies emphasize the integration of drug and device in achieving operational excellence for patient care.
Soligenix, Inc. (SNGX) received a $1.5 million Direct to Phase II SBIR grant from NIAID to support the development of COVID-19 and Ebola vaccine candidates. The funding will enhance the evaluation and manufacturing of the CiVax™ vaccine, known for its heat-stability and ability to induce a robust immune response. The grant aims to facilitate immunogenicity studies in animal models, leveraging the unique properties of the CoVaccine HT™ adjuvant. This initiative aligns with the growing global demand for diverse vaccination solutions amidst the ongoing pandemic.
Soligenix announced preliminary top-line results from its Phase 3 DOM-INNATE trial evaluating SGX942 (dusquetide) for treating severe oral mucositis in head and neck cancer patients undergoing chemoradiation. While the primary endpoint of median duration of SOM did not meet statistical significance (p≤0.05), a 56% reduction was observed, decreasing from 18 days in the placebo group to 8 days in the treatment group. Secondary endpoints indicated a statistically significant 50% reduction in the per-protocol population. The company plans further analysis and has approximately $20 million cash to support its pipeline.