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. reports developments as a late-stage biopharmaceutical company focused on rare diseases and public health medical countermeasures. Company news centers on HyBryte (synthetic hypericin), a visible-light activated therapy program for cutaneous T-cell lymphoma, and SGX945 (dusquetide) for Behçet's Disease, including clinical data, published study results and regulatory designations.
Updates also cover the Public Health Solutions segment, including RiVax ricin toxin vaccine candidate, filovirus vaccine programs, CiVax for COVID-19 and the ThermoVax heat-stabilization platform. Recurring announcements include operating and financial results, government-supported development activities, material agreements, shareholder voting matters and governance updates.
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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.