Soligenix (NASDAQ: SNGX) shares are rallying premarket on Thursday after the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin to treat T-cell lymphoma.
The decision from the FDA extends the target population beyond cutaneous T-cell lymphoma (CTCL).
Orphan drug designation will position the company to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application (NDA), and certain tax credits.
“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,” stated Christopher Schaber, President & CEO of Soligenix.
Soligenix shares are up 16.19% premarket at $1.22.
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