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) 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.
Soligenix, Inc. (Nasdaq: SNGX) announced its financial results for the second quarter of 2021, reporting revenues of $0.2 million compared to $0.5 million in Q2 2020. The net loss decreased to $1.9 million, or ($0.05) per share, attributed to a Paycheck Protection Program loan forgiveness. The company holds approximately $29 million in cash, with plans for U.S. commercialization of its drug HyBryte™ for cutaneous T-cell lymphoma, projecting peak annual net sales to exceed $90 million. Recent regulatory achievements include a Pediatric Investigation Plan waiver from the EMA.
Soligenix, Inc. (SNGX) announced a pivotal Phase 3 trial (FLASH) for its drug HyBryte™ in cutaneous T-cell lymphoma (CTCL) will be presented at the US Cutaneous Lymphoma Consortium Annual Meeting on June 26, 2021. The FLASH trial, the largest of its kind, involved 169 patients and demonstrated significant efficacy, with 16% of HyBryte™ patients achieving at least a 50% reduction in lesions compared to 4% for placebo (p=0.04). HyBryte™ is noted for its safety profile, having received FDA orphan drug and fast track designations.