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Yesterday, 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).
Mon, Aug. 3, 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%)
Wed, May 13, 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.
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.
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).
- 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%)
Sep. 5, 2014, 7:24 AM
- Soligenix (OTCQB:SNGX) acquires the rights to synthetic hpericin from the Yeda Research and Development Company, Ltd., the commercial arm of the Weizmann Institute of Science in Rehovot, Israel. The product candidate, SGX301, is has been tagged an orphan drug by the FDA and is ready to enter into Phase 3 clinical trials for the treatment of cutaneous T-cell lymphoma (CTCL).
- Synthetic hypericin is a photosensitizer that is topically applied to skin lesions and activated by fluorescent light 16 to 24 hours later. In a Phase 2 clinical trial, 58.3% of CTCL patients responded to local hypericin treatment compared to 8.3% in the placebo group. The Phase 3 protocol is currently under FDA review.
Sep. 19, 2013, 12:05 PM
- Soligenix (SNGX.OB +11.2%) jumps after announcing it has received a contract from the Biomedical Advanced Research and Development Authority for the "preclinical and manufacturing development" of the GI ARS treatment OrbeShield.
- The initial deal is for two years and can be extended for up to five total years.
- The contract is valued at up to $26.3M and will help the company "successfully navigate and complete the FDA approval process." (PR)
Sep. 16, 2013, 7:51 AM
- Soligenix (SNGX.OB) scores an orphan designation for the innate defense regulator SGX94 in patients with acute radiation syndrome.
- In clinical models, the drug minimized damage to the skin and gastrointestinal tract, and "enabled clearance of infection as a result of damage to the hematopoietic system." (PR)
Jun. 28, 2013, 7:42 AM
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We are a late-stage biopharmaceutical company developing product candidates intended to address unmet medical needs in areas of inflammation, oncology, and biodefense. We maintain two active business segments: BioTherapeutics and Vaccines/BioDefense. Our BioTherapeutics business segment is... More
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