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Soligenix Announces Submission of New Drug Application to the FDA for HyBryte™ in the Treatment of Cutaneous T-cell Lymphoma
PRINCETON, N.J., Dec. 15, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"PRINCETON, N.J., Dec. 15, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it submitted a new drug application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S. The Company estimates the potential worldwide market for HyBryte™ to be in excess of $250 million for the treatment of CTCL.\n\n \n \n \n \n \n \n\n \n\"The submission of our NDA is a significant milestone for Soligenix, positioning us well to fulfill our promise to offer an innovative first-in-class therapy to the CTCL community of patients, families and healthcare professionals,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. The clinical results we've generated throughout the development program support the potential for HyBryte™ to serve as an important front-line treatment in the management of this chronic cancer. We look forward to working with the FDA through the review process. As the NDA has been granted both FDA orphan drug and fast track designations, we anticipate potential approval in the second half of 2023 as we continue advancing our preparations for U.S. launch, which is currently targeted for first quarter 2024.\"\nAbout HyBryte™HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoid...