SNGX - FDA declines to review Soligenix's photodynamic therapy for cancer

The U.S. Food and Drug Administration (FDA) declined to accept for review Soligenix's ( NASDAQ: SNGX ) new drug application (NDA) seeking approval of HyBryte (synthetic hypericin) to treat early stage cutaneous T-cell lymphoma (CTCL).

The FDA provided the company with a Refusal to File (RTF) letter for the NDA.

Upon preliminary review, the FDA determined that the NDA, submitted in December 2022, was not sufficiently complete to permit a substantive review, the company added.

Soligenix said it is reviewing the letter to determine the next steps, which includes, requesting a Type A meeting with the FDA to clarify and respond to the issues identified and seek guidance related to information that the agency would require for a resubmitted NDA to be deemed acceptable to file.

"We are fully determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path to successfully resubmitting our application," said Soligenix President and CEO Christopher Schaber.

HyBryte (SGX301) is a photodynamic therapy using safe, visible light in the red-yellow spectrum for activation. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light about 24 hours later, according to the company.

SNGX +11.55% to $6.47 premarket Feb. 13

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