Soligenix seeks FDA meeting after damaging HyBryte setback
US rare diseases specialist Soligenix (Nasdaq: SNGX) closed 19% lower after Tuesday’s trading following news of a setback with its lead drug candidate.
Soligenix earlier announced that the US Food and Drug Administration (FDA) had sent the company a Refusal to File letter for its HyBryte (synthetic hypericin) New Drug Application (NDA) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL).
Upon preliminary review, the FDA determined that the NDA, submitted in December, was not sufficiently complete to permit substantive review.
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