FDA hands down RTF letter to rare disease biotech’s lead candidate

A rare disease outfit in Princeton, NJ just got its paperwork punted back by the FDA.

Tiny Soligenix reported Tuesday morning that the FDA handed the company a refusal-to-file letter. Soligenix did not immediately respond to a query from Endpoints News.

The letter targeted an NDA submitted for Soligenix’s lead candidate, a synthetic version of hypericin, which is an active component of a plant called Hypericum perforatum, more commonly known as St. John’s wort. The candidate, branded as HyBryte and touting orphan drug and fast track designations from FDA, was submitted to US regulators to be approved to treat early stage cutaneous T cell lymphoma (CTCL).

CTCL is a rare cancer that starts in the body’s T cells and goes after the skin.

Soligenix did not provide much for details, writing in its release that the FDA, after preliminary review, “determined that the NDA, submitted on December 14, 2022, was not sufficiently complete to permit substantive review.”

Christopher Schaber

The biotech added that it is reviewing the letter, according to its statement, and is working to determine appropriate next steps. Those steps include requesting a meeting with the FDA and asking for additional guidance on what the FDA requires for an acceptable application.

Soligenix CEO and president Christopher Schaber said in a statement that the company is determined to work with FDA as quickly as possible, reiterating that Soligenix is focused on advancing HyBryte.

Investors winced, sending Soligenix’s stock $SNGX down more than 30% in early morning trading. This newest development impacts the company less than a week after it kicked off a 15-to-1 reverse stock split on Feb. 9.

fda
trading
biotech