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Shares of Soligenix Inc. (SNGX) crashed more than 70% to a record low on Tuesday after the biotech firm said its late-stage trial to treat lymphoma suffered a severe blow after an independent committee recommended stopping the study due to a lack of effectiveness.
SNGX stock recorded its biggest intraday loss in more than 14 years.
Soligenix said that an independent data monitoring committee recommended stopping the Phase 3 FLASH2 trial after an interim analysis showed the treatment was unlikely to be effective in patients with cutaneous T-cell lymphoma.
The trial was evaluating HyBryte, a light-activated therapy, in a rare form of cancer with limited treatment options. Management said it will now review the full dataset to understand why the study fell short. The company also plans to assess whether certain patient groups could still benefit from the therapy.
“We are obviously very disappointed with the unanticipated outcome of the study. Despite the fact that HyBryte demonstrated statistically significant reductions in CTCL lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study,” said Christopher J. Schaber, CEO of Soligenix.
Depending on the findings, Soligenix said it may engage in discussions with regulators, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to determine possible next steps.
Last month, the European Commission granted orphan drug designation (ODD) to Dusquetide for the treatment of Behçet’s Disease, following a positive recommendation from the EMA. Behçet’s Disease is a rare, chronic disorder that causes inflammation of blood vessels.
The decision was supported by Phase 2a data showing the drug was effective and safe in patients. Orphan status in Europe gives the company up to 10 years of market exclusivity if the treatment is approved. The drug has already received orphan drug and fast track designations from the FDA.
“With approximately $5.9 million of cash, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities as well as the potential of advancing Dusquetide for the treatment of Behçet’s Disease, which demonstrated promising biological efficacy in a Phase 2 study last year using the intravenous formulation and has received orphan drug designation most recently from the EMA,” Schaber said.
Despite the massive sell-off, retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘extremely high’ message volumes.
The stock has sunk 69% so far in 2026.
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