Soligenix To File US Application For Its Lymphoma Photodynamic Therapy In 2H 2022

In an SEC filing, Soligenix Inc SNGX disclosed that it cannot file its HyBryte marketing application in the U.S. in 1H of 2022.
Citing COVID-19 related disruptions resulting in delays by the commercial active pharmaceutical ingredient manufacturer, the Company cannot provide the pre-requisite accrued stability data required to file the application.
Hence, now the Company anticipates filing in 2H of 2022 with corresponding potential FDA approval in 2H of 2023.
Soligenix is developing HyBryte (SGX301 or synthetic hypericin) as a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL).
Related content: Benzinga's Full FDA Calendar.
Price Action: SNGX shares closed lower by 0.98% at $1.00 on Monday.