Soligenix, Inc. (NASDAQ: SNGX) has disclosed that the Office of Orphan Products Development of the U.S. FDA has awarded orphan drug designation to the active ingredient hypericin for the cure of T-cell lymphoma. The grant of the FDA has sent the stocks of the firm soaring 12.38% during the pre-market trading session of Thursday.
The U.S. Orphan Drug Act is envisioned to help and inspire firms to develop safe and effective therapies for the cure of rare diseases and disorders. In addition to offering a seven-year term of market exclusivity upon final FDA authorization, orphan drug designation also helps Soligenix to utilize a broad range of financial and regulatory advantages.
The advantages which the firm enjoys including government awards for carrying out clinical trials, waiver of expensive FDA user fees for the possible submission of an NDA, and certain tax credits. Furthermore, the decision of the FDA to award and grow its hypericin orphan drug designation ahead of CTCL indicates an important step for Soligenix as the firm continues to promote the program toward NDA filing in the first half of 2022.
Additionally, T-cell lymphomas can develop in lymphoid tissues such as the lymph nodes and spleen, or outside of lymphoid tissues. A similar lymphocyte called a natural killer (NK) cell shares many features with T cells.