Soligenix Inc Stock Price, News & Analysis

Soligenix (SNGX) announced interim results from an open-label study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). The study, supported by a $2.6M FDA grant, shows promising outcomes with over 70% of eligible patients (5 of 6) achieving 'Treatment Success' - defined as ≥50% improvement in mCAILS score.

Of the nine enrolled patients treated for up to 54 weeks, three achieved Treatment Success within 12 weeks, with two reaching complete response by week 18. Two patients recently started the study, while two dropped out for logistical reasons, with one showing >30% improvement at Week 18. The treatment appears safe and well-tolerated across all patients.

The study (RW-HPN-MF-01) aims to enroll approximately 20 U.S. patients for up to 12 months of twice-weekly dosing, with potential transition to home use. This research extends previous positive Phase 2 and 3 clinical trials results.

Soligenix (SNGX) has initiated patient enrollment for its confirmatory Phase 3 FLASH2 study evaluating HyBryte™ for treating cutaneous T-cell lymphoma (CTCL). The study builds on a previous successful Phase 3 FLASH trial, which showed a 49% treatment response rate after 18 weeks of therapy.

The new FLASH2 study will enroll approximately 80 patients with early-stage CTCL across the U.S. and Europe. Unlike the previous trial's three 6-week cycles, FLASH2 will implement 18 weeks of continuous treatment in a randomized, double-blind, placebo-controlled setting. A formal interim analysis is expected in early 2026.

Soligenix announced positive post-treatment data from their open-label study comparing HyBryte™ to Valchlor® in treating rare diseases. The study, involving 10 patients split equally, showed HyBryte™ achieved 60% treatment response versus 20% for Valchlor® after 12 weeks. Notably, 3 of 5 HyBryte™ patients showed continued improvement even 4 weeks after treatment ended, with one achieving complete response. HyBryte™ demonstrated significant efficacy against plaque lesions (75% response rate vs 17% for Valchlor®) and maintained a better safety profile with no related adverse events, compared to 60% adverse event rate in Valchlor® patients.

Soligenix (NASDAQ: SNGX) announced the formation of a European Medical Advisory Board (MAB) to support its upcoming confirmatory Phase 3 study of HyBryte™ for cutaneous T-cell lymphoma (CTCL). The study, set to begin by end of 2024, will be multicenter, double-blind, and placebo-controlled, enrolling approximately 80 patients in the US and Europe. The trial will span 18 weeks with top-line results expected in H2 2026. The European MAB includes renowned CTCL experts Dr. Martine Bagot (France), Dr. Pietro Quaglino (Italy), and Dr. Pablo Luis Ortiz-Romero (Spain), who will provide strategic guidance on clinical development and regulatory interactions.

Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company specializing in rare disease treatments, has announced its participation in the upcoming Q4 Investor Summit on November 21st. The company will deliver a presentation from 12:00 PM to 12:30 PM ET and will be available for one-on-one meetings throughout the event.

The summit will showcase 40 micro-cap companies with catalysts and/or strong market performance. The virtual event features live Q&A sessions and is complimentary for qualified investors, with presentations accessible via webcast.

Soligenix (SNGX) has initiated patient enrollment for a Phase 2 clinical trial evaluating SGX945 (dusquetide) in treating Behçet's Disease. The study received clearance from both FDA and Turkish authorities. The open-label trial will enroll approximately 25 patients with mild to moderate Behçet's Disease and active oral/genital ulcers. Patients will receive twice-weekly IV infusions for 4 weeks, followed by 4 weeks of follow-up. The company expects to announce results in the first half of 2025. The disease affects up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and about 1 million worldwide.

Soligenix (NASDAQ: SNGX) reported its Q3 2024 financial results and recent accomplishments. The company ended the quarter with $9.8 million in cash and reported a net loss of $1.7 million ($0.78 per share). Key developments include preparations for a confirmatory Phase 3 study of HyBryte™ for CTCL treatment and an upcoming Phase 2 study for SGX945 in Behçet's disease. The company secured patents in Hong Kong and Europe for synthetic hypericin production and established a partnership with Sterling Pharma Solutions. Research and development expenses increased to $1.0 million from $0.8 million year-over-year, while general and administrative expenses decreased to $0.9 million from $1.0 million.

Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company focusing on rare disease treatments, has announced its participation in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. Jonathan Guarino, Senior VP and CFO, will present at 9:00 AM ET. The conference brings together institutional investors, corporate clients, and industry professionals to showcase innovations and financial strategies. Company management will be available for one-on-one investor meetings throughout the day.

Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company focusing on rare diseases with unmet medical needs, has announced its participation in three upcoming investor conferences. The company will provide corporate updates at the following events:

• 2024 Maxim Healthcare Virtual Summit on October 17, 2024
• ThinkEquity Conference on October 30, 2024
• Spartan Capital Investor Conference 2024 on November 4, 2024

Key members of Soligenix management will be available for one-on-one meetings during these conferences. Investors unable to attend can schedule meetings by contacting ir@soligenix.com. For more information on each conference, interested parties can visit the respective conference websites provided in the announcement.