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 (Nasdaq: SNGX) announced an update to its U.S. Medical Advisory Board (MAB) for cutaneous T‑cell lymphoma (CTCL) to support the Phase 3 FLASH2 pivotal study of HyBryte (synthetic hypericin) on October 14, 2025. The refreshed MAB includes dermatology and oncology leaders who have served as HyBryte principal investigators and will advise on clinical strategy, patient needs, potential home‑use applications, health economics, reimbursement and worldwide regulatory interactions. The release lists MAB members and credentials, noting clinical experience such as treating >1,000 lymphoma patients and principal‑investigator roles across HyBryte trials.
Soligenix (Nasdaq: SNGX) reported that the first Data Monitoring Committee meeting for its confirmatory Phase 3 FLASH2 study of HyBryte found no safety concerns and an acceptable safety profile consistent with prior trials.
Enrollment is proceeding on track with an ~80-subject randomized, double-blind, placebo-controlled design; an enrollment update is expected in 4Q2025. The DMC will support a pre-specified blinded interim efficacy analysis targeted for 1H2026, and topline results remain planned for the second half of 2026. The summary notes the earlier FLASH Phase 3 observed a 49% treatment response (p<0.0001) in patients completing 18 weeks of therapy.
Soligenix (NASDAQ:SNGX) has announced the expansion of its European Medical Advisory Board (MAB) to support its confirmatory Phase 3 study of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL). The expanded board includes two new esteemed dermatologists, bringing the total to five internationally renowned physicians.
The Phase 3 study will be an 18-week, multicenter, double-blind, placebo-controlled trial evaluating HyBryte™ in early-stage CTCL patients. The study aims to enroll approximately 80 patients with top-line results expected in the second half of 2026.
The expanded MAB will provide strategic guidance for the clinical study, regulatory interactions, and aspects such as health economics and reimbursement. The board includes distinguished members from France, Italy, Spain, the UK, and the Netherlands, each bringing extensive experience in CTCL research and treatment.
Soligenix (NASDAQ:SNGX) has successfully closed its previously announced public offering, raising $7.5 million in gross proceeds. The offering consisted of 5,555,560 shares of common stock (or equivalents) and warrants at a combined price of $1.35 per share and accompanying warrant.
The warrants are immediately exercisable at $1.35 per share and will expire in five years. Additionally, certain existing warrants from May 2023, April 2024, and July 2024 will be amended to match the new $1.35 exercise price. The funding extends Soligenix's cash runway through 2026, supporting research, development, and commercialization activities.
Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company, has announced the pricing of a $7.5 million public offering. The offering includes 5,555,560 shares of common stock (or equivalents) and warrants at a combined price of $1.35 per share and warrant.
The warrants will have an exercise price of $1.35, immediate exercisability, and a five-year expiration. Additionally, certain existing warrants from May 2023, April 2024, and July 2024 will be amended to match the new $1.35 exercise price. The offering is expected to close around September 29, 2025, with A.G.P./Alliance Global Partners serving as the sole placement agent.
Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company, has appointed former White House Economic Adviser Dr. Tomas J. Philipson as Strategic Advisor. Dr. Philipson brings extensive experience in U.S. economic and healthcare policy, having served as vice chairman and acting chairman of the White House Council of Economic Advisers from 2017 to 2020.
Dr. Philipson's notable experience includes advisory roles at the FDA and CMS, and he currently serves as Managing Partner at MEDA Ventures. His appointment comes as Soligenix advances HyBryte™, its lead product candidate, through a confirmatory Phase 3 clinical trial, along with other fast-tracked rare disease pipeline programs.
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.
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