SNGX - Soligenix gets agreement from FDA for photodynamic therapy study in kids for lymphoma
- Soligenix ( NASDAQ: SNGX ) said it received agreement from the U.S. Food & Drug Administration (FDA) on an initial pediatric study plan ((iPSP)) of its photodynamic therapy HyBryte (synthetic hypericin) to treat cutaneous T-cell lymphoma (CTCL).
- The iPSP stipulates that Soligenix plans on requesting a full waiver of pediatric studies upon submission of a new drug application (NDA), the company said in a July 27 press release.
- The company noted that agreement with FDA was one of the regulatory requirements that must be met prior to submitting an NDA.
- SNGX +3.94% to $0.92 premarket July 27
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Soligenix gets agreement from FDA for photodynamic therapy study in kids for lymphoma