Soligenix Shares Surge 25% as JAMA Dermatology Publishes Phase 3 Study Findings
After publishing the results of a recent study evaluating its HyBryte™ treatment for early-stage cutaneous T-cell lymphoma, Soligenix, Inc. (Nasdaq: SNGX) saw its shares jump an impressive 25%. The results of the Phase 3 FLASH study, published in peer-reviewed JAMA Dermatology, demonstrated that HyBryte™ significantly reduced lesion size and highlighted its potential to address a critical gap in treating cutaneous T-cell lymphoma (CTCL).
CTCL is a rare cancer that has no cure and most current treatment options are associated with significant safety concerns. HyBryte™ has demonstrated strong efficacy with a benign safety profile. It was found to be safe and well-tolerated throughout studies, and publication of this data in JAMA Dermatology, an international peer-reviewed journal and one of the highest ranked journals in dermatology, with an acceptance rate of 9%, further validates the importance of the findings.
Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, anticipates submitting a new drug application to the FDA for marketing authorization of HyBryte™ in the treatment of CTCL later this year. As one of the largest studies in CTCL, Soligenix’s research has established a new benchmark in CTCL treatment.
“The peer-reviewed publication of these data in JAMA Dermatology is a testament and further validation to the importance of the findings for the scientific and CTCL disease communities,” stated Ellen Kim, MD, Professor of Dermatology and Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study, in the Soligenix news release.
“With its chronic course and major impact on patient quality of life, CTCL is an orphan disease in urgent need of additional treatment options that are well-tolerated and safe over the long haul. The results from this Phase 3 study, the largest double-blind, randomized, placebo-controlled trial in CTCL to date, represents an important leap forward in the development of potential therapies to meet this unmet medical need.”
Watch the video interview with Dr. Richard Straube, Chief Medical Officer, Soligenix