Soligenix, Inc. (SLGX), a late-stage biopharmaceutical company, announced that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial evaluating its lead investigational product, HyBryte (Synthetic Hypericin), for the treatment of cutaneous T-cell lymphoma (CTCL) and recommended halting the trial due to futility.
Following the news, SGNX is down 66% at $0.48.
Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval.
In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion and exclusion criteria.
Soligenix will determine the reasons the study did not meet expectations and, if further analysis of the dataset provides clarity, it will communicate its findings and explore follow-up discussions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Christopher J. Schaber, President and Chief Executive Officer of Soligenix, said, "With approximately $5.9 million of cash, we will evaluate all strategic options moving forward"
SGNX has traded between $0.47 and $6.23 over the last year. The stock closed Monday's trade at $1.41.
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