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Monday, April 3, 2023

Soligenix Sets Type A Meeting with the U.S. FDA for Treatment of Cutaneous T-Cell Lymphoma

  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 granted a Type A meeting to discuss the contents of a refusal to file (RTF) letter previously issued 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.

https://www.biospace.com/article/releases/soligenix-announces-scheduling-of-type-a-meeting-with-the-u-s-fda-for-hybryte-new-drug-application-in-the-treatment-of-cutaneous-t-cell-lymphoma/

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