Soligenix Submits New Drug Application to FDA

Soligenix, Inc., (Nasdaq: SNGX), a late-stage biopharmaceutical company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for HyBryte™, a treatment for cutaneous T-cell lymphoma (CTCL).  Watch the video interview.  Soligenix estimates the potential worldwide market for HyBryte™ (synthetic hypericin) to be in excess of $250 million for the treatment of CTCL.

Highlights 

• The submission of the NDA positions Soligenix to fulfill its promise to offer an innovative first-in-class therapy to CTCL patients.
• HyBryte™ potentially represents the safest available efficacious treatment for CTCL, with very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic.
• Soligenix anticipates potential approval in the second half of 2023 and is targeting its U.S. launch in the first quarter of 2024.

CTCL is a rare, chronic cancer that is difficult to treat and remains an area of unmet medical need with a very limited number of safe and effective treatment options. It affects more than 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.