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Soligenix Inc. (NASDAQ: SNGX) Advances Phase 3 Replication Study for Early-Stage Cutaneous T-Cell Lymphoma Treatment

  • Soligenix is enrolling patients in its FLASH2 study, with a formal interim analysis anticipated early in 2026.
  • SNGX’s HyBryte is a novel photodynamic therapy using synthetic hypericin activated by safe visible light.
  • The ongoing phase 3 replication study meets stringent requirements of regulatory agencies to strengthen the case for HyBryte as a commercially available treatment.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company specializing in the development and commercialization of treatments for rare diseases and unmet medical needs, is making significant strides in its efforts to bring innovative therapies to patients with early-stage cutaneous T-cell lymphoma (“CTCL”). The company’s lead candidate, HyBryte(TM) (“SGX301”), has already demonstrated positive results in a prior phase 3 trial, and Soligenix is now conducting a phase 3 replication study to further validate its efficacy and safety (https://ibn.fm/zdRnQ). This development marks an important milestone in the company’s mission to address an urgent medical need in a condition with limited treatment options.

“We are pleased to be initiating patient enrollment into our FLASH2 study,” said Soligenix president and CEO Christopher J. Schaber (https://ibn.fm/LjfXu). “FLASH2 is expected to enroll patients in the United States and Europe, with a formal interim analysis anticipated early in 2026. Given the extensive…

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NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX

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