Soligenix Says FDA Grants Type A Meeting Regarding New Drug Application For HyBryte
(RTTNews) - Biopharmaceutical company Soligenix, Inc. (SNGX) announced Monday that the 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.
The company has successfully demonstrated statistically significant results in a Phase 3 clinical trial.
The company said it intends to provide a further update once it receives the minutes from the meeting or when it has more clarity on next steps, which is anticipated by or before the end of April.
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