Soligenix Inc Stock Price, News & Analysis

Soligenix (Nasdaq: SNGX) announced the successful long-term stability testing of its ebolavirus vaccines using the ThermoVax® platform. The company demonstrated that both bivalent and trivalent vaccine formulations maintained their potency after two years of storage at temperatures up to 40°C (104°F).

In collaboration with the University of Hawaiʻi, the vaccines, which target Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed significant stability advantages. The vaccines only require reconstitution with sterile water before use, eliminating complex cold-storage requirements typical of other vaccine technologies.

The research highlights the potential of Soligenix's ThermoVax® platform in developing thermostable vaccines that could improve global vaccination efforts, particularly in virus-endemic African regions and strategic national stockpiles.

Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The company's CEO, Christopher J. Schaber, Ph.D., will deliver a corporate presentation during the event scheduled for September 8-10, 2025.

The on-demand presentation will be available starting September 5th at 7:00 AM ET for registered attendees through the conference platform. Management will also conduct one-on-one meetings throughout the conference, with scheduling available through the conference platform.

Soligenix (NASDAQ:SNGX) has received FDA orphan drug designation for dusquetide (SGX945) for the treatment of Behçet's Disease, following promising Phase 2a clinical results. This designation provides seven years of market exclusivity upon FDA approval and various financial benefits including government grants, FDA fee waivers, and tax credits.

The treatment targets a rare disorder affecting up to 18,000 people in the U.S. and approximately 1 million worldwide. The Phase 2 proof-of-concept study demonstrated clinically meaningful improvements in patients with oral aphthous ulcers due to Behçet's Disease, addressing an significant unmet medical need in this chronic auto-immune condition.

Soligenix (NASDAQ:SNGX) reported its Q2 2025 financial results and recent accomplishments. The company posted a net loss of $2.7 million ($0.82 per share) compared to $1.6 million ($1.31 per share) in Q2 2024. The company held $5.1 million in cash as of June 30, 2025, plus $1.4 million received via ATM facility on July 1, providing runway through Q1 2026.

Key developments include completion of Phase 2a proof of concept study for SGX945 in Behçet's Disease, successful manufacturing transfer of synthetic hypericin to the US, and ongoing clinical trials. The company expects top-line results from Phase 2a psoriasis trial with SGX302 before year-end 2025, and anticipates Phase 3 HyBryte™ CTCL study results in 2026.

Soligenix (NASDAQ: SNGX) is advancing its HyBryte™ platform to address the growing need for effective treatments in cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer primarily affecting older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient.

The development comes amid increasing healthcare challenges related to rare diseases, which affect over 30 million Americans. The initiative aligns with the "Make America Healthy Again" program, which aims to improve treatment access and accelerate medical innovation, particularly for an aging population facing complex healthcare needs and often experiencing diagnostic delays.

Soligenix (NASDAQ: SNGX) is advancing its HyBryte™ platform to address the growing need for treatments in rare diseases, specifically targeting cutaneous T-cell lymphoma (CTCL), a rare skin cancer affecting primarily older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient.

This development aligns with healthcare initiatives aimed at improving treatment access and accelerating medical innovation, particularly relevant as over 30 million Americans live with rare diseases. The company's focus on CTCL represents a strategic move to address an underserved therapeutic area, especially significant given the aging American population and the challenges in diagnosing rare diseases in seniors.

Soligenix (NASDAQ: SNGX) has announced positive results from its Phase 2a clinical trial of SGX945 (dusquetide) for treating Behçet's Disease. The study demonstrated biological efficacy comparable to the approved drug apremilast (Otezla®), showing a 40% improvement in oral ulcers versus placebo after 4 weeks of treatment.

Key findings include sustained improvement even 4 weeks after treatment cessation, with 7 out of 8 patients reporting benefits. Unlike apremilast, which requires continuous administration and has side effects like diarrhea (41%), nausea (19%), and headache (14%), SGX945 showed no treatment-related adverse events. The company plans to reformulate SGX945 for subcutaneous home-based treatment and proceed with a placebo-controlled Phase 2 study.

Soligenix (Nasdaq: SNGX) provided a corporate update highlighting key developments and upcoming milestones. The company's late-stage rare disease pipeline includes HyBryte™ for cutaneous T-cell lymphoma (CTCL), with top-line results from the 80-patient Phase 3 FLASH2 trial expected in H2 2026. The trial has shown promising results with 75% treatment success after 18 weeks of continuous treatment.

Additional pipeline developments include SGX302 for psoriasis with Phase 2a results expected in Q4 2025, and SGX945 for Behçet's Disease with Phase 2a results anticipated in Q3 2025. The company projects potential peak annual U.S. sales of $90 million for HyBryte™, with a total addressable global market of over $2B across all programs. Soligenix reports approximately $7 million in cash, providing runway into Q1 2026.

Soligenix (Nasdaq: SNGX) has successfully completed the transfer of synthetic hypericin manufacturing from Europe to the United States through its partnership with Sterling Pharma Solutions. The manufacturing process transfer includes optimization and implementation of a commercially viable, scalable production process for the active ingredient used in HyBryte™ and SGX302 formulations.

The synthetic hypericin is being developed for treating cutaneous T-cell lymphoma (CTCL) and psoriasis. The companies have established cGMP manufacturing capabilities for clinical trials and are working towards a long-term commercial manufacturing collaboration. Sterling's expertise includes innovative solutions such as continuous flow chemistry for this product.