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Soligenix Inc Stock Price, News & Analysis

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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.

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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.

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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.

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Soligenix (SNGX) highlights Dr. Ellen Kim's Q&A discussion regarding HyBryte™, their novel photodynamic therapy for treating cutaneous T-cell lymphoma (CTCL). Dr. Kim, Lead Principal Investigator for Phase 3 FLASH studies, emphasized the urgent need for safer CTCL treatments, noting no new FDA-approved skin-directed therapy in over 10 years. HyBryte™ shows promising clinical results with unique advantages: it's non-mutagenic, doesn't damage DNA, has no systemic absorption, and is well-tolerated. The therapy specifically targets mycosis fungoides, the most common form of CTCL, with no serious adverse events reported in trials. Dr. Kim, who serves as a professor at the University of Pennsylvania and Director of the Penn Cutaneous Lymphoma Program, expressed optimism about ongoing clinical trials and their potential impact on early-stage CTCL treatment.
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Soligenix (SNGX) reported its Q1 2025 financial results and recent accomplishments. The company posted a net loss of $3.2 million ($1.06 per share), compared to $1.9 million ($2.91 per share) in Q1 2024. Research and development expenses increased to $2.2 million, up from $1.1 million in the previous year. The company reported no revenue for Q1 2025, down from $0.1 million in Q1 2024. As of March 31, 2025, Soligenix maintained a cash position of $7.3 million, which is expected to sustain operations through December 2025. The company anticipates key milestones including top-line results from its Phase 3 HyBryte™ study for CTCL in 2026 and Phase 2 results for SGX945 and SGX302 in H2 2025.

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Soligenix (SNGX) announced positive interim results from an FDA-funded study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). After 18 weeks of treatment, 75% of patients achieved Treatment Success, defined as ≥50% improvement in mCAILS score.

Of the eight evaluable patients through Week 18, four completed the 54-week treatment with an average maximum improvement of 85% in mCAILS score, three remain on treatment, and one dropped out due to logistical issues. The study, led by Dr. Ellen Kim at Penn Cutaneous Lymphoma Program, demonstrates HyBryte's™ rapid response compared to other CTCL therapies that typically take 6-12 months for meaningful results.

The ongoing open-label study aims to enroll approximately 20 patients, supported by an FDA Orphan Products Development Grant of up to $2.6 million. The results reinforce HyBryte's™ potential as a safe and fast-acting therapy for this rare cancer.

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Soligenix (NASDAQ: SNGX) has published preclinical efficacy results for CiVax™, their thermostabilized subunit vaccine against SARS-CoV-2. The study demonstrated that combining a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) with a CiVax™ booster induced broader protection against COVID-19 variants in non-human primates compared to a traditional 2-shot mRNA vaccination series.

The research, conducted in collaboration with Dr. Axel Lehrer from the University of Hawaiʻi, showed that CiVax™ generates rapid-onset multi-variant booster responses when used in a heterologous prime-boost approach. A key advantage of CiVax™ is its thermostability, allowing ambient temperature shipping and requiring only sterile water reconstitution before use.

The vaccine leverages Soligenix's ThermoVax® platform, which has successfully stabilized vaccines for ricin toxin and filoviruses. This technology enhances standard protein subunit vaccination, potentially offering a safer alternative that doesn't require strict cold-storage requirements like mRNA vaccines.

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Soligenix (SNGX) reported its financial results for the year ended December 31, 2024, with a net loss of $8.3 million ($4.98 per share) compared to $6.1 million in 2023. Revenue decreased to $0.1 million from $0.8 million in the previous year.

The company maintains $7.8 million in cash, providing operational runway through 2025. Research and development expenses increased to $5.2 million from $3.3 million, while general and administrative expenses decreased to $4.2 million from $4.5 million.

Key developments include patient enrollment for the confirmatory Phase 3 study of HyBryte™ in CTCL treatment, with top-line results expected in 2026. Additionally, top-line results from Phase 2 studies for SGX945 in Behçet's disease and SGX302 in psoriasis are anticipated in the second half of 2025.

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Soligenix (NASDAQ: SNGX) announced upcoming presentations of their HyBryte™ (synthetic hypericin) treatment studies at two major medical conferences in March 2025. The presentations will showcase data from recent supportive trials in cutaneous T-cell lymphoma (CTCL) and psoriasis treatments.

The findings will be presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop on March 6 and the American Academy of Dermatology (AAD) Annual Meeting from March 7-11 in Orlando, Florida. Dr. Ellen Kim from Penn Cutaneous Lymphoma Program will present results from an ongoing investigator-initiated study on HyBryte™'s long-term CTCL treatment, while Dr. Neal Bhatia will discuss topical and photodynamic therapy considerations at AAD.

The presentations will include findings from recent supportive studies demonstrating longer treatment efficacy, minimal systemic hypericin exposure after topical application, and comparative efficacy against Valchlor®.

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Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in the upcoming BIO CEO & Investor Conference. The event is scheduled for February 10-11, 2025 in New York, N.Y.

The company, which focuses on developing and commercializing products for unmet medical needs in rare diseases, will deliver a corporate presentation during the conference. Registered attendees have the opportunity to schedule one-on-one meetings with Soligenix management through the conference scheduling platform. Those unable to attend can arrange meetings by contacting ir@soligenix.com.

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Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in two upcoming investor conferences. The company will present at the Sequire Investor Summit from January 21-23 at Condado Vanderbilt, Puerto Rico, and The Microcap Conference from January 28-30 at Borgata Hotel Casino & Spa in Atlantic City, N.J.

Key management members will be available for one-on-one meetings during both conferences. Registered attendees can schedule meetings through the conference platforms. Investors unable to attend can arrange meetings by contacting ir@soligenix.com.

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FAQ

What is the current stock price of Soligenix (SNGX)?

The current stock price of Soligenix (SNGX) is $1.27 as of July 11, 2025.

What is the market cap of Soligenix (SNGX)?

The market cap of Soligenix (SNGX) is approximately 3.9M.
Soligenix Inc

Nasdaq:SNGX

SNGX Rankings

SNGX Stock Data

3.92M
3.15M
0.03%
1.22%
4.01%
Biotechnology
Pharmaceutical Preparations
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United States
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