Soligenix submits type a meeting request to u.s. fda for hybryte™ new drug application in the treatment of cutaneous t-cell lymphoma

Meeting expected to occur approximately 30 days from the fda's receipt of meeting request princeton, n.j. , march 9, 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 company has submitted a type a meeting request to the united states (u.s.) food and drug administration (fda) to discuss the contents of a refusal to file (rtf) letter previously issued by the fda regarding the company's new drug application (nda) for hybryte™ (synthetic hypericin) in the treatment of early stage cutaneous t-cell lymphoma (ctcl), a rare cancer, where it has successfully demonstrated statistically significant results in a phase 3 clinical trial.
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