| Previous Close | 0.7500 |
| Open | 0.7500 |
| Bid | 0.6500 x 900 |
| Ask | 0.7300 x 800 |
| Day's Range | 0.7000 - 0.7538 |
| 52 Week Range | 0.6500 - 2.2000 |
| Volume | 85,726 |
| Avg. Volume | 115,332 |
| Market Cap | 12.823M |
| Beta (3Y Monthly) | 1.92 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.5260 |
| Earnings Date | Aug 6, 2019 - Aug 12, 2019 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 5.63 |
On April 18, 2019, Soligenix, Inc. (SNGX) announced that it has reached the enrollment target for the Phase 3 clinical trial of SGX942 (dusquetide) to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC). The Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) clinical trial is evaluating SGX942 for the treatment of sever oral mucositis (OM) in patients with squamous cell carcinoma of the oral cavity and oropharynx undergoing chemoradiation therapy.
PRINCETON, N.J., May 14, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2019. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We have completed the approximate 90 subject enrollment necessary to support the interim efficacy analysis of our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. This interim analysis, to be conducted by the independent Data Monitoring Committee (DMC) for the trial, is anticipated to occur in September 2019.
On April 18, 2019, Soligenix, Inc. (SNGX) announced that it has reached the enrollment target for the Phase 3 clinical trial of SGX942 (dusquetide) to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC). The Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) clinical trial is evaluating SGX942 for the treatment of sever oral mucositis (OM) in patients with squamous cell carcinoma of the oral cavity and oropharynx undergoing chemoradiation therapy.
PRINCETON, N.J., April 23, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.
PRINCETON, N.J., April 18, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has reached a significant milestone in the Phase 3 clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC).
PRINCETON, N.J., April 15, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received approximately $611,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program. This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey.
PRINCETON, N.J., April 9, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) agreed to the Company's Pediatric Investigation Plan (PIP) for SGX942 (dusquetide). It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer (HNC). As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population.
PRINCETON, N.J., April 4, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the US Patent Office will issue the patent titled "Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity" on April 9, 2019. The new patent (#10,253,068) claims composition of matter for novel innate defense regulator (IDR) analogs, expanding patent protection to more diverse analog structures. Therapeutic use claims in oral mucositis, colitis, and infectious disease, both alone and in conjunction with antibiotics, will also issue.
Soligenix, Inc. (SNGX) is currently conducting the randomized, multinational, double blind, placebo controlled Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) clinical trial, which is evaluating SGX942 (dusquetide) for the treatment of severe oral mucositis (OM) in patients with squamous cell carcinoma of the oral cavity and oropharynx undergoing chemoradiation therapy. Important secondary endpoints that are being evaluated include tumor progression and overall survival at 12 months.
PRINCETON, N.J., March 26, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2018. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are actively enrolling patients in our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.
PRINCETON, N.J., March 11, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Chief Scientific Officer, Oreola Donini, PhD, will deliver a corporate presentation at the Boston Oncology Investor Conference 2019 on Thursday, March 14 at 5:35 PM ET. The event will take place at 28 State Street, Boston, MA.
Soligenix, Inc. (SNGX) recently published a review of the potential clinical applications for innate defense regulators (IDRs), including the company’s lead IDR asset SGX942. IDRs modulate the innate immune response, which is composed of both physical barriers (e.g., skin, mucosal surfaces, etc.) as well as specialized myeloid and lymphoid sensor and effector cells (Gasteiger et al., 2017). IDRs exert their effects through binding of p62 (sequestosome-1), which is involved in a number of different innate immune signaling networks (Yu et al., 2009).
PRINCETON, N.J., Feb. 11, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the allowance of a new United States (US) patent protecting its ricin toxin vaccine, RiVax®. The patent, titled "Multivalent Stable Vaccine Composition and Methods of making same", supports combination vaccines protecting against ricin intoxication as well as other toxins, such as those associated with anthrax. RiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. The RiVax® antigen has demonstrated safety in two Phase 1 clinical studies.
PRINCETON, N.J., Feb. 7, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of a scientific article demonstrating the successful thermostabilization of an Ebola subunit vaccine candidate. The article titled, "Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide", is published in the European Journal of Pharmaceutics and Biopharmaceutics online and is available here. As previously announced, Soligenix has been collaborating with the University of Hawai'i at Mānoa (UH Mānoa) and Hawaii Biotechnology, Inc. (HBI) on the development of a multivalent subunit vaccine for Ebola and Marburg infections.
PRINCETON, N.J., Jan. 23, 2019 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Patent Office has granted the patent entitled "Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity." The newly issued patent claims composition of matter of innate defense regulator (IDR) analogs, expanding patent protection around the Company's lead IDR, dusquetide. Similar claims have been previously allowed in the United States (US) and are being pursued in other worldwide jurisdictions.
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PRINCETON, N.J., Dec. 11, 2018 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $611,000 in net proceeds by year end. This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey.
PRINCETON, N.J., Dec. 5, 2018 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of a review article discussing the therapeutic applications of its innate immune modulator technology, including dusquetide (the active ingredient in SGX942), its lead clinical Innate Defense Regulator (IDR). The article entitled, "Targeting Innate Immunity to Treat Disease: Potential Therapeutic Applications", is published in the journal Drug Target Review online and is available here. Innate immune modulation as a therapeutic intervention reflects our enhanced understanding of an ancient aspect of the immune system. With our increasingly sophisticated exploration of innate immunity, it has become possible to manipulate this system in a beneficial manner, potentially benefiting a wide range of patient populations, including oncology, oncology supportive care, infectious disease and acute and chronic inflammatory conditions. These applications have been made possible by recent studies identifying the intricacies of the signaling pathways, and the ability to differentially impact these pathways. Dusquetide is one of the first therapeutic approaches in this field, and is initially being developed in the context of oncology supportive care. Preclinical data with dusquetide has demonstrated a wide range of potential application, including in gastrointestinal inflammation, infectious disease and oncology, discussed in the presentation here. This brief review explores some of these concepts and proposes that innate immune modulation may become as important as other adaptive immune approaches (e.g., checkpoint inhibitors, CAR-T therapies) in the future.
Revenues were comprised of non-dilutive government grants and contracts in support of RiVax®, SGX301, and SGX942 as well as a subaward from the Ebola collaboration with the University of Hawaii. The increase was mainly due to increased costs associated with the ongoing Phase 3 clinical trials. As of September 30, 2018, Soligenix had cash and cash equivalents of $11.7 million, due in part to a registered direct offering in July 2018 that raised net proceeds of $8.4 million.
NEW YORK, Nov. 14, 2018 -- In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors,.
PRINCETON, N.J., Nov. 12, 2018 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Dr. Oreola Donini, Chief Scientific Officer, will be presenting data from the ricin toxin vaccine (RiVax®) program describing development of the vaccine under the Food and Drug Administration (FDA) Animal Rule. The presentation will be given at the upcoming Fourth International Conference on Vaccines Research & Development on November 13-15, 2018 to be held at the Radisson Hotel Baltimore Downtown-Inner Harbor, MD.
PRINCETON, N.J., Nov. 9, 2018 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the third quarter ended September 30, 2018. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "Our primary focus remains the quality execution of our two pivotal Phase 3 clinical programs. Following the positive recommendation recently received from the independent Data Monitoring Committee (DMC), we continue to enroll patients in our double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin).
On October 15, 2018, Soligenix, Inc. (SNGX) announced a positive recommendation from the independent Data Monitoring Committee (DMC), which conducted an unblinded analysis of the company’s ongoing Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial. The trial is testing the company’s lead product, SGX301, as a treatment for cutaneous T cell lymphoma (CTCL). The DMC recommended that the company enroll an additional 40 subjects into the trial to maintain 90% statistical power for the primary endpoint.
To clear up any confusion regarding the DMC’s recommendation and what it means for the study we spoke with Dr. Richard Straube, Soligenix’s Chief Medical Officer, and asked him a few questions regarding the outcome of the interim analysis. David Bautz: Some investors may be surprised by the required addition of 40 patients to the study. Dr. Straube: First, we want to make it clear that nothing is wrong with the study and we weren’t far off with our estimated enrollment of approximately 120 patients.
PRINCETON, N.J. , Oct. 15, 2018 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat ...