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).

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