FDA grants Soligenix Fast Track status for SGX301
Late-stage biopharma company Soligenix (OTCQB: SNGX) has said that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the US Food and Drug Administration.
The designation means that Soligenix will be eligible to submit a New Drug Application for SGX301 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of around six months.
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