Soligenix Schedules Type A Meeting with the FDA Regarding New Drug Application
Late-stage biopharmaceutical company, Soligenix, Inc., (Nasdaq: SNGX) has scheduled a type A meeting with the FDA to discuss the contents of a refusal to file letter previously issued regarding the Company’s new drug application for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL).
Soligenix expects to provide an update on the meeting outcome by the end of April, 2023. The company’s shares rose 4% pre-market following the announcement.
- Soligenix has successfully demonstrated statistically significant results in a Phase 3 clinical trial evaluating HyBryte™ as a treatment for CTCL, a rare cancer.
- The company intends to work with the FDA to better understand the open issues and clarify the potential path forward.
- HyBryte™ is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation.
- Visible light has the ability to penetrate more deeply into the skin than ultraviolet (UV) light, potentially enabling it to treat deeper skin disease and thicker plaques and lesions, while avoiding the risk of secondary malignancies such as melanoma.
- HyBryte’s™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.
- HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing and commercializing products to treat rare diseases where there is an unmet medical need. The company’s Specialized BioTherapeutics business segment is moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). Soligenix’s development programs also include synthetic hypericin (SGX302) as a potential treatment for psoriasis and dusquetide (SGX942) for the treatment of inflammatory diseases. Soligenix’s Public Health Solutions business segment includes active development programs for RiVax®, a ricin toxin vaccine candidate, SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease, vaccine programs targeting filoviruses and CiVax™, a vaccine candidate for COVID-19.