- The FDA has provided a Refusal to File (RTF) letter for Soligenix Inc’s SNGX HyBryte (synthetic hypericin) new drug application (NDA) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL).
- Upon preliminary review, the FDA determined that the NDA submitted was not sufficiently complete to permit substantive review.
- Soligenix first learned of the RTF decision via this letter and is reviewing its contents to determine the appropriate next steps.
- The company plans to request a Type A meeting with the FDA to clarify and respond to the issues identified in the letter and to seek additional guidance.
- Related: Soligenix Shares Gain On HyBrytes Data From Blood Cancer Study.
- When the company submitted the application to the FDA, it anticipated potential approval in the second half of 2023, and the U.S. launch targeted for the first quarter of 2024.
- Price Action: SNGX shares are down 33.60% at $3.85 on the last check Tuesday.
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