Soligenix revealed that it has received a Refusal to File letter from the FDA in response to Soligenix’s nondisclosure agreement regarding its synthetic hypericin to treat patients with cutaneous T-cell lymphoma. Soligenix announced that they are currently reviewing the contents of the letter but plan to request a Type A meeting with the FDA in order to clarify the decision and determine how to proceed with a subsequent nondisclosure agreement. “We remain focused on advancing [synthetic hypericin] as a potential new first-in-class treatment option for the cutaneous T-cell lymphoma community of patients, families, and health-care professionals,” concluded Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
April 30, 2023