Soligenix, Inc. (SNGX) - OTCQB
  • Mon, Jul. 25, 11:07 AM
    • Soligenix (OTCQB:SNGX -4.6%) announces that it has received $634K in new funding to support the development of OrbeShield (oral beclomethasone 17,21 dipropionate or BDP) as a medical countermeasure for civilian and military use to treat gastrointestinal acute radiation syndrome (GI ARS). The Biomedical Advanced Research and Development Authority (BARDA) chipped in $350K while NIH's National Institute of Allergy and Infectious Diseases (NIAID) contributed $284K.
    • Total funding from the two groups will be as high as $33M if all contract options are exercised ($18M has been committed thus far).
    • ARS occurs after toxic radiation exposure. It typically damages three organ systems: the bone marrow, GI tract and lungs. Orphan Drug- and Fast Track-tagged OrbeShield is a two-tablet regimen, one releases BDP in the proximal portions of the GI tract and the other releases BDP in the distal portions. BDP has been marketed worldwide since the early 1970s as the active ingredient in inhalation products for the treatment of allergic rhinitis and asthma.
    | Mon, Jul. 25, 11:07 AM
  • Tue, May 31, 1:36 PM
    • The FDA designates Soligenix's (OTCQB:SNGX +1.4%) investigational SGX943 (dusquetide) for Fast Track review for the treatment melioidosis, a potentially fatal infection caused by the Gram-negative bacterium Burkholderia pseudomallei, which is highly resistant to many antibiotics. It is a major public health issue in Southeast Asia and Northern Australia. The mortality rate can be as high as 40%.
    • Dusquetide is a member of a class of peptides called an innate defense regulator (IDR) which has no direct antibiotic activity but modulates host responses, increasing survival and accelerating the resolution of tissue damage following exposure to pathogens.
    • Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    | Tue, May 31, 1:36 PM | 3 Comments
  • Wed, May 25, 7:38 AM
    • The National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) exercises its option to evaluate Soligenix's (OTCQB:SNGX) ricin toxin vaccine candidate, RiVax, in animal efficacy and toxicology studies. It will contribute $3.2M to fund the work.
    • NIAID has funded $16.7M to date to advance RiVax, which could increase to $24.7M if all contract options are exercised.
    • The overall objective of the contract is the advance the development of the company's ThermoVax thermostabilization technology, combined with RiVax, as a medical countermeasure to prevent the effects of ricin exposure.
    • Ricin is an extraordinarily potent toxin, lethal to humans at a dose the size of a grain of salt. It is an attractive biological weapon for terrorists because it is a readily available by-product of the production of castor oil, a vegetable oil that is used in the manufacturing of soaps, lubricants, brake fluids, paints, dyes, inks, plastics, drugs, perfumes and nylon. Castor oil is produced throughout the world.
    | Wed, May 25, 7:38 AM
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  • Dec. 21, 2015, 9:08 AM
    • No doubt incentivized by recent clinical trial success, SciClone Pharmaceuticals (NASDAQ:SCLN) announces plans to develop and register Soligenix's (OTCQB:SNGX) SGX942 in greater China for the treatment of oral mucositis (OM) in patients with head and neck cancer.
    • SciClone's decision is pursuant to its April 2013 collaboration deal with Soligenix that gave it commercialization rights to SGX942 in China, Hong Kong and Macau in exchange for providing Soligenix access to its oral mucositis clinical and regulatory data library, which SciClone built while it was developing its own candidate for OM, SCV-07, abandoned in 2012.
    • Specific terms of the partnership are not disclosed.
    • SGX942 is a synthetic peptide called an innate defense regulator that modulates the body's reaction to injury and infection.
    • Previously: Soligenix's candidate for oral mucositis shows encouraging results in mid-stage study (Dec. 16)
    | Dec. 21, 2015, 9:08 AM
  • Dec. 16, 2015, 8:24 AM
    • Soligenix (OTCQB:SNGX) announces positive results from a Phase 2 clinical trial assessing SGX942 for the treatment of severe oral mucositis (OM) in patients undergoing chemoradiation therapy (CRT) for head and neck cancer.
    • Patients receiving 1.5 mg/kg of SGX942, a synthetic peptide called an innate defense regulator that modulates the body's reaction to injury and infection, experienced a median reduction in the duration severe OM of 50% (18 days to nine days; p=0.099) while those undergoing the most aggressive CRT showed a median duration reduction of 67% (30 days to 10 days; p=0.040).
    • The data will be submitted for publication and presentation at a future scientific conference.
    • OM usually occurs in the mouth of patients undergoing anticancer therapies. It affects ~500K Americans or 40% of those receiving chemo and almost all head and neck cancer patients receiving chemoradiation.
    • The FDA has designated SGX942 for Fast Track review for the indication.
    • The company will host a conference call this morning at 9:00 am ET to discuss its recent clinical trial results and development milestones.
    • OM-related tickers: (OTCPK:CTIX)(NASDAQ:AMAG)(NYSE:XON)(NYSEMKT:OGEN)(NASDAQ:SCMP)
    | Dec. 16, 2015, 8:24 AM | 8 Comments
  • Dec. 14, 2015, 11:31 AM
    • Soligenix (OTCQB:SNGX +1%) commences enrollment in its Phase 3 clinical trial evaluating Fast Track- and Orphan Drug-tagged SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma, a rare type of non-Hodgkin's lymphoma where the malignant cells migrate to the skin.
    • According to clinicaltrials.gov, the primary endpoint is at least a 50% improvement in three treated lesions as determined by CAILS score (a composite measurement). The estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is October 2017.
    • SGX301 is a novel photodynamic therapy in which hypericin, a photosensitizer, is applied to cancerous skin lesions and activated using a brief fluorescent light treatment.
    | Dec. 14, 2015, 11:31 AM
  • Dec. 9, 2015, 10:48 AM
    • Thinly traded nano cap Soligenix (OTCQB:SNGX -2.2%) receives ~$490K in non-dilutive financing via New Jersey's Technology Business Tax Certificate Transfer Program which enables approved unprofitable biotech firms to sell their unused Net Operating Loss Carryovers and unused Research & Development Tax Credits to unaffiliated profitable corporate taxpayers based in the state.
    • The New Jersey Economic Development Authority determines eligibility for the Program, the New Jersey Division of Taxation determines the value of the tax benefits and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state is the originator of the Program and the first to implement and fund it.
    • The company's pipeline includes SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma and SGX94 (susquetide) for the treatment of oral mucositis in head and neck cancer (SGX942) and melioidosis (SGX943).
    | Dec. 9, 2015, 10:48 AM | 4 Comments
  • Dec. 3, 2015, 12:40 PM
    • Thinly traded nano cap Soligenix (OTCQB:SNGX -27.5%) slumps again today on a 5x surge in volume. Shares are down over 40% over the past two days on no particular news.
    • The company is sponsoring one ongoing clinical trial, a Phase 2 evaluating Fast Track-tagged SGX942, a 5-amino acid peptide, for the treatment of oral mucositis (OM) in head and neck cancer patients undergoing chemo and/or radiation treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, improvement in OM symptoms four weeks after the end of therapy, is December 2015. The estimated study completion date is August 2016.
    • On November 25, the FDA designated Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse, Brilacidin-OM, for Fast Track review for OM. The oral rinse formulation presents a distinct advantage over SGX942's intravenous route of administration.
    • A Phase 3 study evaluating SGX301, photoactivated hypericin, for the treatment of cutaneous T-cell lymphoma is set to begin shortly. The primary endpoint is the response in three treated lesions defined as at least a 50% improvement in CAILS score (a composite measurement) compared to placebo. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is October 2017. SGX301 is designated an Orphan Drug in both the U.S. and Europe for the indication.
    • Previously: Cellceutix's Brilacidin-OM Fast Track'd for oral mucositis (Nov. 25)
    | Dec. 3, 2015, 12:40 PM | 7 Comments
  • Aug. 19, 2015, 9:29 AM
    • The National Institute of Allergy and Infectious Diseases exercises it option to advance the development of Soligenix's (OTCQB:SNGX) heat stable ricin toxin vaccine, RiVax, whereby it will provide an additional $2.7M in funding. If all contract options are exercised, the total award will be $24.7M.
    • Ricin is an extraordinarily potent toxin, lethal to humans at a dose the size of a grain of salt. It is an attractive biological weapon for terrorists because it is a readily available by-product of the production of castor oil, a vegetable oil that is used in the manufacturing of soaps, lubricants, brake fluids, paints, dyes, inks, plastics, drugs, perfumes and nylon. Castor oil is produced throughout the world.
    | Aug. 19, 2015, 9:29 AM
  • Aug. 4, 2015, 9:19 AM
    • Late-stage biopharmaceutical company Soligenix ([SGNX]) announces it received orphan drug designation from the European Commission for SGX301. SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation that is being developed for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease and a class of non-Hodgkin's lymphoma.
    • Orphan drug designation in will provide Soligenix with various development incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
    • SGX301 has previously been granted both orphan drug and fast track designations from the FDA for the first-line treatment of CTCL.
    • The company is currently working to initiate a 120 subject pivotal Phase 3 clinical trial with SGX301 in 2H 2015.
    • Previously: Soligenix gets orphan designation for SGX94 (Sept. 16, 2013).
    | Aug. 4, 2015, 9:19 AM | 1 Comment
  • Aug. 3, 2015, 9:37 AM
    • Soligenix (OTCQB:SNGX) announces it has entered into a $10 million equity purchase agreement with accredited institutional investors, Kingsbrook Opportunities Master Fund LP and River North Equity, LLC. Brean Capital, LLC served as financial advisor for this transaction.
    • Soligenix will file a registration statement with the Securities and Exchange Commission. Once effective, the company will have the right to sell up to $10 million worth of common stock under the terms set forth in the agreement.
    • Proceeds from this transaction will be used to help fund the company's ongoing development initiatives of its late-stage product candidates, including its pivotal Phase 3 clinical study of SGX301 in the treatment of cutaneous T-cell lymphoma.
    • Related tickers: (XON +1.2%)
    | Aug. 3, 2015, 9:37 AM
  • May 13, 2015, 10:54 AM
    • Soligenix (OTCQB:SNGX +3.4%) initiates a development agreement with Emergent BioSolutions (EBS +0.4%) to implement a commercially viable, scalable production technology for RiVax, an investigational vaccine candidate to protect against ricin exposure. It will transfer the manufacturing processes and analytics to EBS to conduct further development that could lead to a commercial manufacturing collaboration.
    • The company is developing RiVAx, in conjunction with its heat stabilization technology, ThermoVax, as a heat-stable biodefense vaccine. In preclinical testing, RiVax demonstrated 100% protection from lethal ricin exposure and stability up to one year at 40 degrees Celsius (132 degrees Fahrenheit). This supports the intent to stockpile the product at ambient temperature.
    • The National Institute of Allergy and Infectious Diseases (NIAID) is funding the RiVax project.
    • Ricin is a highly toxic protein produced in the seeds of the castor oil plant. A grain-of-salt-size dose can kill a human. It is considered a bioterror threat due to its worldwide availability as a by-product of castor oil production.
    | May 13, 2015, 10:54 AM
  • Dec. 19, 2014, 1:24 PM
    • Soligenix (OTCQB:SNGX -19.3%) prices its public offering of 1,886,530 units at $1.21 per unit. Each unit consists of one share of common stock and 0.6 of a warrant to purchase one share of common stock at $1.48 per share. Closing date is December 24.
    • Net proceeds will fund R&D activities and general corporate purposes.
    | Dec. 19, 2014, 1:24 PM
  • Oct. 7, 2014, 9:54 AM
    • Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
    • The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
    • Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
    • In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
    • S-1
    • Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
    • Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
    • Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
    | Oct. 7, 2014, 9:54 AM
Company Description
We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. We maintain two active business segments: BioTherapeutics and Vaccines/BioDefense. Our BioTherapeutics business segment is developing a... More
Sector: Healthcare
Industry: Drug Manufacturers - Other
Country: United States