- The FDA has granted orphan drug designation to the active ingredient hypericin to treat T-cell lymphoma, extending the target population beyond cutaneous T-cell lymphoma (CTCL) as previously granted.
- "The FDA's decision to grant and expand our hypericin orphan drug designation beyond CTCL signifies an important step for Soligenix as we continue to advance the program toward NDA filing in the first half of 2022," said Christopher J. Schaber, President & CEO.
- Soligenix Inc's SNGX HyBryte (SGX301) is a photodynamic therapy utilizing safe, visible light for activation.
- The active ingredient in HyBryte is synthetic hypericin.
- The potent photosensitizer that is topically applied to skin lesions is taken up by the malignant T-cells and then activated by visible light 16 to 24 hours later, which triggers apoptosis of the cell.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: SNGX shares are up 8.10% at $1.14 during the market session on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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