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Soligenix, Inc. - SNGX STOCK NEWS

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.

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Soligenix has submitted a Type A Meeting Request to the FDA for discussions on a second Phase 3 study of HyBryte™ (SGX301) for treating cutaneous T-cell lymphoma (CTCL). This follows significant success in the initial Phase 3 FLASH trial, where 16% of patients treated with HyBryte™ showed at least a 50% reduction in lesions compared to 4% for the placebo (p=0.04). The FDA has classified the meeting as high priority, expected within approximately 30 days. HyBryte™ utilizes synthetic hypericin and visible light, posing a safer alternative to conventional treatments by avoiding DNA damage. The company anticipates alignment with the FDA on a pivotal study design to expedite further development of this promising treatment.

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Soligenix, Inc. (NASDAQ: SNGX) announced a Type A Meeting with the FDA regarding its NDA for HyBryte™ aimed at treating cutaneous T-cell lymphoma (CTCL). The FDA previously issued a refusal to file (RTF) letter, necessitating positive results from an additional clinical study alongside the Phase 3 FLASH study. Soligenix plans to work closely with the FDA to define the protocol for this new trial. The FLASH study showed statistically significant results, with a 16% response rate for HyBryte™ versus 4% for placebo. HyBryte™ is a photodynamic therapy using synthetic hypericin sodium and has received orphan drug and fast track designations. The additional study requirements mark a setback for the company, but leadership remains committed to advancing the treatment for patients with CTCL.

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Soligenix (NASDAQ: SNGX) announced the approval of the nonproprietary name "hypericin sodium" by the USAN Council for its active ingredient in HyBryte™ (SGX301) and SGX302. This novel compound is designed for treating cutaneous T-cell lymphoma (CTCL) and mild-to-moderate psoriasis. In clinical trials, HyBryte™ showed a 58.3% response rate in CTCL and an 80% response in psoriasis. However, an NDA for CTCL is facing an FDA Refusal to File (RTF) due to completeness issues. A Type A meeting with the FDA is scheduled to clarify the RTF concerns. The company continues to pursue further development in psoriasis with SGX302.

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Soligenix, Inc. (Nasdaq: SNGX) has announced that the FDA has granted a Type A meeting to discuss the refusal to file letter concerning the NDA for HyBryte™ (synthetic hypericin), aimed at treating cutaneous T-cell lymphoma (CTCL). The meeting is anticipated to provide clarity on the issues raised in the RTF letter. The company emphasizes the significant results obtained in the Phase 3 FLASH trial, where HyBryte™ demonstrated a 16% response rate in reducing lesions. Additionally, HyBryte™ is noted for its safety profile, being a non-DNA damaging treatment. An update is expected by the end of April.

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Soligenix, Inc. (SNGX) reported its financial results for the year ending December 31, 2022, showing revenues of $0.9 million compared to $0.8 million in 2021. The company faced a net loss of $13.8 million or ($4.81) per share, up from $12.6 million or ($4.69) per share in the previous year. Key developments include a Type A FDA meeting regarding its HyBryte™ NDA for treating early-stage cutaneous T-cell lymphoma and the expansion of synthetic hypericin (SGX302) into psoriasis trials. The cash position was approximately $13.4 million at year-end, indicating managed cash burn to reach near-term goals.

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Soligenix, Inc. (SNGX) has submitted a Type A Meeting Request to the U.S. FDA to discuss a refusal to file letter related to its NDA for HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL). This meeting is anticipated within 30 days of the FDA's receipt of the request. The Phase 3 FLASH trial showed statistically significant results, with 16% of HyBryte™ patients achieving a 50% lesion reduction compared to 4% in the placebo group. HyBryte™ utilizes safe, visible light for treatment, avoiding risks associated with traditional therapies. Soligenix is advancing regulatory approval and commercialization efforts for HyBryte™.

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FAQ

What is the current stock price of Soligenix (SNGX)?

The current stock price of Soligenix (SNGX) is $2.84 as of December 23, 2024.

What is the market cap of Soligenix (SNGX)?

The market cap of Soligenix (SNGX) is approximately 7.2M.

What does Soligenix, Inc. specialize in?

Soligenix, Inc. specializes in developing and commercializing biopharmaceutical products to address unmet medical needs in inflammation, oncology, and biodefense.

What are the key projects under Soligenix's Specialized BioTherapeutics segment?

Key projects include HyBryte™ for cutaneous T-cell lymphoma (CTCL), SGX302 for psoriasis, SGX942 for oral mucositis in head and neck cancer, and SGX945 for Behçet's disease.

What is ThermoVax®?

ThermoVax® is Soligenix's proprietary heat stabilization platform technology used in the development of thermostable vaccines.

What achievements has Soligenix recently made?

Recent achievements include additional patents for their trivalent filovirus vaccine platform and positive clinical trial results for HyBryte™.

Who are some of Soligenix's key partners?

Key partners include the University of Hawaiʽi at Mānoa and funding organizations like NIAID and BARDA.

What financial milestones has Soligenix achieved?

Soligenix recently raised $4.75 million through a public offering and has secured substantial non-dilutive government funding.

What is HyBryte™?

HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin for the treatment of cutaneous T-cell lymphoma (CTCL).

What is CiVax™?

CiVax™ is Soligenix's vaccine candidate for the prevention of COVID-19.

What is RiVax®?

RiVax® is Soligenix's ricin toxin vaccine candidate developed under its Public Health Solutions segment.

What are Soligenix's key areas of focus in vaccine development?

Soligenix focuses on developing vaccines for filoviruses (including Marburg and Ebola) and COVID-19, using its ThermoVax® technology.

Soligenix, Inc.

Nasdaq:SNGX

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7.23M
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0.03%
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Biotechnology
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