SNGX - Soligenix seeks FDA meeting for review of cancer photodynamic therapy

2023-03-09 08:22:11 ET

• Soligenix ( NASDAQ: SNGX ) said it has submitted a request for a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss a letter in which the agency declined to accept for review an application seeking approval of HyBryte.
• In February, the FDA issued a refusal to file (RTF) letter in response to the company's new drug application (NDA) for HyBryte (synthetic hypericin) to treat early stage cutaneous T-cell lymphoma (CTCL).
• "We believe the briefing package submitted with our request addresses the items raised in the RTF letter and will assist with discussions regarding the NDA," said Soligenix's President and CEO Christopher Schaber.
• The company expects the meeting to occur in about 30 days from the FDA's receipt of the meeting request.
• According to Soligenix, HyBryte (SGX301) is a photodynamic therapy which uses visible light in the red-yellow spectrum for activation. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions that is taken up by cancerous T-cells, and then activated by visible light about 24 hours later.

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