Soligenix Inc Stock Price, News & Analysis

Soligenix (SNGX) provided an update on its strategic plans and development pipeline in a letter from CEO Dr. Christopher J. Schaber. Key upcoming milestones include submitting an NDA for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) and initiating a Phase 2 trial for SGX302 in psoriasis. HyBryte™ shows potential peak U.S. sales exceeding $90 million, with a global psoriasis market opportunity over $1 billion. Additionally, ongoing development of vaccines and the significance of a $20 million partnership with Pontifax were highlighted, ensuring sufficient capital into 2023.

Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company, announced its participation in two upcoming virtual investor conferences. The H.C. Wainwright BioConnect Conference will take place from January 10-13, 2022, with an on-demand presentation available starting January 10 at 7 AM ET. The Biotech Showcase will be held from January 10-12 and 17-19, 2022, with presentations for registered attendees commencing on January 10. Soligenix's management will also conduct one-on-one meetings throughout both conferences.

Soligenix, Inc. (Nasdaq: SNGX) announced that dusquetide shows significant efficacy in reducing tumor size in nonclinical models, reinforcing previous studies. It was effective both as a standalone therapy and in combination with radiation and chemotherapy for the MCF-7 breast cancer cell line. Dusquetide has also shown positive results in reducing severe oral mucositis, leading to enhanced survival rates. The company is exploring further product opportunities in oncology, motivated by strong Phase 2 and 3 study data. Dusquetide holds Fast Track Designation for treating oral mucositis, with a robust intellectual property portfolio backing its development.

Soligenix, Inc. (SNGX) announced successful 100% protection of non-human primates against lethal Sudan ebolavirus using a bivalent, thermostabilized vaccine. This achievement highlights the potential of their vaccine platform, crucial for pandemic preparedness. The vaccine maintains full potency and can be reconstituted with just water, enabling storage at ambient temperatures. The ongoing collaboration with the University of Hawaiʻi aims to accelerate vaccine development for various filoviruses, including Sudan and Marburg, which currently lack effective vaccines.

Soligenix (SNGX) announced its Q3 2021 financial results, reporting revenues of $0.2 million compared to $0.6 million in Q3 2020. The net loss increased to $3.6 million or ($0.09) per share, driven by reduced revenues and higher R&D costs primarily for HyBryte™. The Company holds approximately $29 million in cash and is preparing for an NDA filing for HyBryte™, which has received orphan drug designation for T-cell lymphoma. Additionally, Soligenix plans to expand synthetic hypericin development into psoriasis with a Phase 2a trial set for mid-2022.

Soligenix, Inc. (Nasdaq: SNGX) announced it received a Pediatric Investigation Plan (PIP) waiver from the Medicines and Healthcare products Regulatory Agency (MHRA) for its treatment, HyBryte™ (SGX301), for cutaneous T-cell lymphoma (CTCL). This waiver facilitates regulatory processes in the UK, avoiding costly pediatric clinical studies. Earlier, the EMA granted a similar waiver. The Phase 3 FLASH trial demonstrated significant efficacy, with 40% of patients responding positively to HyBryte™. Soligenix emphasizes the safety of HyBryte™ compared to existing therapies, marking a crucial step in advancing its clinical development.

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 6^th 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.