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. (NASDAQ: SNGX) is a late-stage biopharmaceutical company headquartered in Princeton, New Jersey. The company is dedicated to developing and commercializing products that address unmet medical needs, particularly in the areas of inflammation, oncology, and biodefense. Soligenix operates through two business segments: Specialized BioTherapeutics and Public Health Solutions.
Under the Specialized BioTherapeutics segment, Soligenix focuses on rare disease treatments. Key projects include HyBryte™ (SGX301), a novel photodynamic therapy using synthetic hypericin for cutaneous T-cell lymphoma (CTCL). HyBryte™ has shown promising results in Phase 3 clinical trials and is on track for regulatory approvals in the United States and Europe. Other development programs include SGX302 for psoriasis, SGX942 for oral mucositis in head and neck cancer, and SGX945 for Behçet's disease.
The Public Health Solutions segment emphasizes vaccine development and biodefense. Notable projects include RiVax®, a ricin toxin vaccine candidate, and thermostable vaccine candidates for filoviruses such as Marburg and Ebola. These vaccines are developed using the company's proprietary heat stabilization platform technology, ThermoVax®. Soligenix has also been active in developing CiVax™, a vaccine candidate for COVID-19.
Recent achievements include additional patents for their trivalent filovirus vaccine platform and positive clinical trial results for HyBryte™. Financially, the company reported a net loss for the quarter ended March 31, 2024, but successfully raised $4.75 million through a public offering. Soligenix has also secured significant non-dilutive government funding to support its various development programs.
Partnerships with esteemed institutions like the University of Hawaiʽi at Mānoa and funding from organizations such as the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) further bolster Soligenix's research and development efforts. With a robust pipeline and strategic collaborations, Soligenix aims to deliver significant long-term value to its shareholders and address critical healthcare needs globally.
Soligenix (NASDAQ: SNGX) has been granted a European patent for its novel method of producing synthetic hypericin, the active ingredient in HyBryte™, a photodynamic therapy for cutaneous T-cell lymphoma (CTCL). This patent (EP3423428) complements a similar US patent and is expected to expire in 2036. HyBryte™ is a first-in-class treatment that uses visible light to activate hypericin applied to CTCL skin lesions, avoiding risks associated with DNA-damaging chemotherapies and UV-dependent therapies.
The company is set to initiate a confirmatory Phase 3 clinical trial (FLASH2) for HyBryte™ in Q4 2024, following statistically significant efficacy results in a previous Phase 3 trial. Soligenix aims to address the unmet medical need in CTCL, an orphan disease, with support from organizations like the Cutaneous Lymphoma Foundation.
RedChip Companies will air interviews with Soligenix Inc. (Nasdaq:SNGX) and American Resources Corp. on Bloomberg TV on August 17, 2024. Soligenix, a late-stage biopharmaceutical company, highlights its strong portfolio with products targeting a potential $2 billion in annual global sales. Key developments include:
1. HyBryte™, a photodynamic therapy for cutaneous T-cell lymphoma, with positive Phase 3 results and $250 million market potential.
2. SGX302 for psoriasis in Phase 2a trial, with over $1 billion market potential.
3. SGX945 for Behçet's Disease, entering Phase 2a later this year.
4. Collaborations and non-dilutive funding supporting vaccine development, including a filovirus vaccine program showing complete protection in non-human primates.
Soligenix (Nasdaq: SNGX) reported its Q2 2024 financial results and recent accomplishments. Key highlights include:
1. Positive clinical results from a comparability study of HyBryte™ vs. Valchlor® in CTCL treatment, showing a three-fold higher response rate and better safety profile.
2. Upcoming initiation of a confirmatory Phase 3 study for HyBryte™ in early-stage CTCL.
3. Planned Phase 2 study of SGX945 in Behçet's disease, with top-line results expected in H1 2025.
4. Q2 2024 financial results: revenues of <$0.1M, net loss of $1.6M ($1.31 per share), and cash position of $9.1M as of June 30, 2024.
5. Regained compliance with Nasdaq's Minimum Bid Price Rule.
Soligenix, a late-stage biopharmaceutical company, announced promising interim results for its HyBryte™ treatment in an open-label, investigator-initiated study for early-stage cutaneous T-cell lymphoma (CTCL). Supported by a $2.6 million FDA Orphan Products Development Grant, the study evaluated HyBryte™ treatment extended up to 12 months. Six patients have been enrolled, with 75% of patients who completed at least 12 weeks of therapy achieving 'Treatment Success,' defined as a ≥50% improvement in their cumulative mCAILS score. The treatment has been well-tolerated with no adverse events reported. The study aims to enroll up to 50 patients and will provide additional data as it progresses.
Soligenix announced positive results from a comparative study evaluating HyBryte™ against Valchlor® for treating cutaneous T-cell lymphoma (CTCL). The open-label study involved 10 patients over a 12-week treatment period. Results showed that 60% of HyBryte™ patients achieved a 50% or greater improvement in their mCAILS score, compared to 20% for Valchlor®. HyBryte™ also demonstrated a more favorable safety profile, with no adverse events reported, while 60% of Valchlor® patients experienced therapy-related adverse events. The study supports previous Phase 2 and 3 findings and sets the stage for a Phase 3 placebo-controlled study later this year.
Soligenix, a biopharmaceutical firm, announced that Professor Axel Lehrer will present key data on the company's thermostable vaccine platform at the ASM Microbe Conference, June 13-17, 2024. The discussion will include results from the filovirus vaccine candidates SuVax™ and MarVax™ for Sudan ebolavirus and Marburg marburgvirus. These vaccines, developed with the University of Hawaiʽi, use a thermostabilization method that enables stability at higher temperatures, simplifying logistics. The vaccines have shown complete protection in non-human primate studies. Soligenix has also received Orphan Drug Designation for these vaccines.
Soligenix and Sharps Technology will be featured in interviews on the RedChip Small Stocks, Big Money™ show on Bloomberg TV, airing June 8 at 7 p.m. ET. Soligenix, a late-stage biopharmaceutical company, highlights its promising portfolio, including HyBryte™ for cutaneous T-cell lymphoma, which showed positive Phase 3 results and has a $250 million market potential. It also features SGX302 for psoriasis and SGX203 for pediatric Crohn's disease, targeting markets over $1 billion collectively. Sharps Technology, meanwhile, has secured a $200 million Sales Agreement and acquired Nephron Pharmaceuticals' InjectEZ facility, positioning itself as North America's first dedicated polymer prefillable syringe manufacturer. Projected revenues include $35 million in the first 12 months, with potential growth up to $100 million by 2028.
Soligenix (NASDAQ: SNGX) announced a reverse stock split at a 1-for-16 ratio, effective at 4:00 p.m. on June 5, 2024. Trading on a split-adjusted basis will begin June 6, 2024. The reverse split will reduce the number of outstanding shares from approximately 15.8 million to around 987,490 shares. Stockholders' equity percentage remains unchanged, and fractional shares will be rounded up. No new stock certificates are required, but proportional adjustments will be made to equity awards and warrants. Stockholders with brokerage accounts will see automatic adjustments. The new CUSIP number is 834224 604.
Soligenix, a late-stage biopharmaceutical company focusing on rare diseases, is urging its stockholders to vote at the reconvened annual meeting on May 30, 2024. Only those holding shares as of April 10, 2024, are eligible, even if shares were later sold. Voting can be done by proxy via Alliance Advisors at 1-833-782-7145. The company emphasizes the importance of stockholder participation. Proxy materials and proposals can be found on the SEC's website or Soligenix's investor relations page. This solicitation material contains important information for making informed voting decisions.
Soligenix (Nasdaq: SNGX) announced the adjournment of its 2024 Annual Meeting of Stockholders initially scheduled for May 23, 2024, due to insufficient voting power representation.
With only 48% of the outstanding shares represented, the meeting lacked the quorum necessary to conduct business.
The meeting will reconvene on May 30, 2024, at 9:00 a.m. ET, held virtually via audio webcast.
Stockholders as of April 10, 2024, are encouraged to vote promptly via Internet, phone, or by contacting Alliance Advisors.
FAQ
What is the current stock price of Soligenix (SNGX)?
What is the market cap of Soligenix (SNGX)?
What does Soligenix, Inc. specialize in?
What are the key projects under Soligenix's Specialized BioTherapeutics segment?
What is ThermoVax®?
What achievements has Soligenix recently made?
Who are some of Soligenix's key partners?
What financial milestones has Soligenix achieved?
What is HyBryte™?
What is CiVax™?
What is RiVax®?