Mon. 1 Nov 2021, 4:36pm ETBenzinga
In: Biotech, News, Penny Stocks, Health Care, FDA, General
  • In an SEC filingSoligenix Inc (NASDAQ: 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.