Soligenix receives refusal to file letter from u.s. fda for hybryte™ new drug application in the treatment of cutaneous t-cell lymphoma

Soligenix intends to seek guidance from the fda on how to further advance hybryte ™  towards potential approval princeton, n.j. , feb. 14, 2023 /prnewswire/ -- soligenix, inc. (nasdaq: sngx) (soligenix or the company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the united states (u.s.) food and drug administration (fda) has provided the company with a refusal to file (rtf) letter for its hybryte™ (synthetic hypericin) new drug application (nda) in the treatment of early stage cutaneous t-cell lymphoma (ctcl), a rare cancer and area of unmet medical need affecting over 25,000 patients in the u.s.  upon preliminary review, the fda determined that the nda, submitted on december 14, 2022, was not sufficiently complete to permit substantive review.
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