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Soligenix Announces Recent Accomplishments And Year-End 2022 Financial Results
PRINCETON, N.J., March 31, 2023 /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., March 31, 2023 /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 its recent accomplishments and financial results for the year ended December 31, 2022.\nChristopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, \"2023 will be another important year for Soligenix. We are preparing for a Type A Meeting with the United States (U.S.) Food and Drug Administration (FDA) to discuss the contents of a refusal to file (RTF) letter issued by the FDA in response to the Company's new drug application (NDA) for HyBryte™ (synthetic hypericin) submitted in December 2022. The Type A meeting with the FDA will provide clarity regarding the issues raised in the RTF letter with respect to the NDA for HyBryte™ in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, which has successfully demonstrated statistically significant results in a Phase 3 clinical trial. In addition to HyBryte™, we have expanded synthetic hypericin's (SGX302) development into mild-to-moderate psoriasis where we have begun patient enrollment in a Phase 2a study. We anticipate the clinical study results in the second half of 2023.\nWith approximately $13.4 million in cash at year end, not including our non-dilutive government funding, we continue to manage cash burn very carefully to achieve our near-term milestones, as we continue to assess all strategic options, including but not limited to, partnership and merger and acquisition opportunities.\" \nSoligenix Recent Accomplishments\nOn March 9, 2023, the Company announced it had submitted a Type A meeting request to the U.S. FDA to discuss the contents of a RTF letter previously issued by the FDA regarding the Company's NDA for HyBryte™ (synthetic hypericin) in the treatment of early stage CTCL. To view this press release, please click here.On February 14, 2023, the Company announced that the U.S. FDA had provided the Company with a RTF letter for its HyBryte™ NDA in the treatment of early stage CTCL. To view this press release, please click here.On February 9, 2023, the Company announced that it intended to effect a reverse stock split of its common stock at a ratio ...