- Soligenix Inc (NASDAQ:SNGX) convened a Type A Meeting with the FDA, discussing the contents of a refusal to file (RTF) letter previously issued by the FDA regarding the Company’s new drug application (NDA) for HyBryte (synthetic hypericin sodium) for early-stage cutaneous T-cell lymphoma (CTCL).
- To accept an NDA filing for HyBryte, the FDA requires positive results from a second study in addition to the Phase 3 FLASH study previously conducted in this orphan indication.
- The FDA indicated that it is open to discussing the second clinical study protocol.
- “The Phase 3 FLASH study was the largest double-blind, randomized, placebo-controlled clinical trial ever conducted in the CTCL population. While we are surprised that the FDA did not accept our submitted NDA for filing and review, it was very clear that the FDA’s thinking has evolved in evaluating CTCL therapies since our initial protocol discussions on Study HPN-CTCL-01 and that another Phase 3 study will be required to support an NDA for HyBryte,” said Christopher Schaber President & CEO.
- Price Action: SNGX shares are down 14.90% at $1.40 on the last check Friday.
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