The company said enrollment in its Phase 3 HyBryte study is progressing well, with an interim efficacy analysis planned for the first half of 2026.
Shares of Soligenix rallied sharply on Tuesday, marking their best performance in nearly two months, after the biopharmaceutical company reported a key safety milestone in its confirmatory Phase 3 FLASH2 trial evaluating HyBryte (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL).
The stock jumped 20% to $1.64 on Tuesday, and added another 0.9% after hours in continued upbeat trading.
The company said its first Data Monitoring Committee (DMC) meeting for the study concluded that there were no safety concerns, with HyBryte’s safety profile consistent with prior trials.
The committee’s conclusion allows the trial to move ahead as planned, with enrollment proceeding well and an update expected in the fourth quarter of 2025, followed by a blinded interim efficacy analysis in the first half of 2026.
The ongoing FLASH2 trial is a randomized, double-blind, placebo-controlled, multicenter study enrolling about 80 patients with early-stage CTCL. The study builds on Soligenix’s previous successful Phase 3 FLASH trial, which showed a 49% treatment response after 18 weeks of therapy.
FLASH2 extends continuous double-blind treatment to 18 weeks, designed to demonstrate the drug’s effect over a more “real-world” course.
HyBryte, which uses visible light-activated synthetic hypericin applied topically to skin lesions, has received orphan drug and fast-track designations from the FDA, along with an orphan designation from the European Medicines Agency (EMA). The company stated that its light-activated mechanism enables deeper penetration into skin tissue without causing DNA damage, positioning it as a potentially safer frontline therapy for CTCL.
On Stocktwits, retail sentiment for Soligenix was ‘extremely bullish’ amid a 2,025% surge in 24-hour message volume.
One bullish user described the latest Soligenix update as a strong catalyst, saying the stock appeared ready to rebound sharply after the morning dip and could test new highs in the coming sessions.
Another bullish user noted that the price action suggested momentum might continue, with potential for a multiday run.
Soligenix’s stock has declined 39% so far in 2025.
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