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 repeatedly described in its public communications as a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. News about SNGX often centers on progress across its two segments, Specialized BioTherapeutics and Public Health Solutions, and provides updates on clinical trials, regulatory designations, advisory boards and financing activities.
In the Specialized BioTherapeutics segment, recent press releases highlight the ongoing confirmatory Phase 3 FLASH2 study of HyBryte™ (SGX301, synthetic hypericin sodium) for cutaneous T-cell lymphoma (CTCL), including enrollment milestones and interim safety reviews. Additional news covers Phase 2a clinical results for SGX302 in mild-to-moderate psoriasis, emphasizing improvements in standard psoriasis indices with synthetic hypericin-based photodynamic therapy, and publications and regulatory designations for SGX945 (dusquetide) in Behçet's Disease, including orphan drug designation from the FDA.
Coverage of Soligenix also includes updates on its innate defense regulator (IDR) technology platform, describing dusquetide’s role in modulating the innate immune response, and on its Public Health Solutions programs such as the RiVax® ricin toxin vaccine candidate, filovirus vaccines and CiVax™ for COVID-19, which use the ThermoVax® heat-stabilization platform and have received support from agencies like NIAID, DTRA and BARDA.
Investors following SNGX news can expect announcements about clinical trial milestones, peer-reviewed publications, FDA orphan and fast track designations, medical advisory board expansions in CTCL, as well as capital markets events such as public offerings and Nasdaq listing compliance updates. Bookmarking the SNGX news page on Stock Titan can help track these developments in one place as the company advances its rare-disease and biodefense pipeline.
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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.
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.
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.
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.
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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