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Last $1.72 USD
Change Today +0.0301 / 1.78%
Volume 243.0K
As of 8:10 PM 05/22/15 All times are local (Market data is delayed by at least 15 minutes).

soligenix inc (SNGX) Snapshot

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03/6/15 - $2.30
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soligenix inc (SNGX) Details

Soligenix, Inc., a late-stage biopharmaceutical company, engages in developing products to address unmet medical needs in the areas of inflammation, oncology, and biodefense. It operates through two segments, BioTherapeutics and Vaccine/Biodefense. The BioTherapeutics segment develops proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation comprising pediatric Crohn’s disease and acute radiation enteritis, as well as innate defense regulator technology for the treatment of oral mucositis in head and neck cancer. This segment also develops SGX301, a photo-dynamic therapy for the treatment of cutaneous T-cell lymphoma. The Vaccines/BioDefense segment is developing RiVax, a ricin toxin vaccine candidate; VeloThrax, an anthrax vaccine candidate; OrbeShield, a gastrointestinal acute radiation syndrome therapeutic candidate; and SGX943, a melioidosis therapeutic candidate. These vaccine programs are supported by the company’s ThermoVax heat stabilization technology. Soligenix, Inc. has collaboration with Intrexon Corporation to develop and commercialize a human monoclonal antibody therapy (SGX101) to treat melioidosis. The company was formerly known as DOR BioPharma, Inc. and changed its name to Soligenix, Inc. in 2009. Soligenix, Inc. was founded in 1987 and is headquartered in Princeton, New Jersey.

17 Employees
Last Reported Date: 03/27/15
Founded in 1987

soligenix inc (SNGX) Top Compensated Officers

Chairman, Chief Executive Officer and Preside...
Total Annual Compensation: $527.0K
Acting Chief Financial Officer, Vice Presiden...
Total Annual Compensation: $232.0K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $362.0K
Compensation as of Fiscal Year 2014.

soligenix inc (SNGX) Key Developments

Soligenix, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2015

Soligenix, Inc. reported earnings results for the first quarter ended March 31, 2015. The company's revenues for the quarter ended March 31, 2015 were $0.8 million as compared to $0.9 million for the first quarter of 2014. Revenues included contracts with the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) in support of OrbeShield™ (oral beclomethasone 17,21-dipropionate or BDP) development for the treatment of gastrointestinal acute radiation syndrome (GI ARS) and a contract with NIAID to advance the development of RiVax™, its proprietary ricin toxin vaccine, in conjunction with its heat stabilization technology, ThermoVax™, as a medical countermeasure to prevent the effects of ricin exposure. The company's basic net loss was $4.6 million, or $0.19 per share, as compared to $3.3 million, or $0.17 per share, for the first quarter ended March 31, 2015 and 2014, respectively. Included in the net loss for the quarter ended March 31, 2015 and 2014 is a non-cash loss of $3.0 million and $1.7 million, respectively. This non-cash item reflects the increase in fair value of the liability related to warrants issued in connection with the company's June 25, 2013 registered public offering and is included in other income (expense).

Soligenix, Inc. Announces FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX203 in Pediatric Crohn's Disease

Soligenix, Inc. announced that agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its product, SGX203 (oral beclomethasone 17,21-dipropionate or BDP), in the treatment of pediatric Crohn's disease. SGX203 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Crohn's Disease in the pediatric population. SGX203 is a proprietary formulation of BDP that uses a two-tablet immediate and delayed release system to orally deliver high mucosal concentrations of the topical steroid to both the upper and lower bowel walls. This makes SGX203 particularly well suited for Crohn's disease in younger patients that are reported to have gastrointestinal (GI) inflammation in both areas of the bowel as opposed to adults who have mainly lower (colon) involvement. Oral BDP has a limited systemic absorption into the blood stream, decreasing the potential for the development of adverse side-effects frequently seen with systemic steroid therapies, like prednisone. These side effects include bone demineralization and interference with normal growth, which are particularly concerning in children. The upcoming pivotal Phase 3 study will be a double-blind, randomized, controlled, multi-national trial and will seek to enroll approximately 150 subjects 6-17 years of age with endoscopically proven mild to moderate Crohn's disease. The trial will compare the rates of improvement of the signs and symptoms of Crohn's disease after 8 weeks of treatment among subjects randomized to one of three SGX203 dose groups (split 60:30:60 among the lowest, middle and high dose of SGX203). Subjects will be followed for an additional 6 months after the completion of treatment. Entry criteria for the trial are the presence of Crohn's disease symptoms (abdominal pain and/or diarrhea) associated with laboratory evidence of active disease in the blood. The primary clinical efficacy endpoint of the trial will compare the percentage of subjects in each of the three dose groups having resolved their signs and symptoms after an 8-week course of treatment. An adaptive design will be employed in which an independent Data Monitoring Committee will review the efficacy data after approximately 90 subjects have completed treatment and determine if the trial size requires adjustment based on the actual event rate or halted for futility or overwhelming efficacy. The trial is anticipated to begin in the second half of 2015 with primary data available in the first half of 2017.

DSG, Inc. Partners with Soligenix to Battle Cutaneous T-Cell Lymphoma

DSG has teamed up with Soligenix to provide EDC, IWRS Web-based patient randomization and data management services for their current Phase 3 clinical study of SGX301 (synthetic hypericin) coupled with visible light activation in the treatment of Cutaneous T-Cell Lymphoma. eCaselink significantly increases clinical trial management speed while reducing study management cost. A truly integrated solution, DSG’s eCaselink seamlessly combines EDC, Risk-Based Monitoring, eSource, ePRO, IWRS, Safety, Site Payments and CTMS into a single harmonized system. DSG’s clinical study build tool makes initial EDC startup intuitive and fast, with unparalleled support services and hands-on training for self-build studies, used also by DSG’s team in providing full service SaaS software systems. eCaseLink IWRS, an integrated component in the EDC software, will help Soligenix manage randomization and subject enrollment in their clinical trial. DSG will manage all aspects of clinical study data management from database setup through lock. DSG's data management team will add value to their EDC service by providing Soligenix with clean, timely, and cost-effective deliverables throughout the lifespan of the study. With 23 years of clinical trial software and services experience, DSG will provide value added services including the development and design of customized databases, design and review of eCRFs, data validation/verification programming, comprehensive data management plans, ongoing review of data and logic checks, laboratory data management, data encoding, reconciliation of serious adverse events, and database lock, submission and archiving. Soligenix has found that taking advantage of the eCaseLink end-to-end integrated product suite, combined with the knowledge and commitment of the DSG team, is helping them reach their clinical trial goals.


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