SNGX - Soligenix stock sinks as FDA seeks additional positive results for cancer drug

2023-04-14 08:05:10 ET

Soligenix ( NASDAQ: SNGX ) shares fell ~12% premarket on Friday after the biopharmaceutical company disclosed that the U.S. FDA is seeking more positive results to accept an NDA filing for its HyBryte drug.

HyBryte is a light-activated ointment for the treatment of early stage cutaneous T-cell lymphoma (CTCL). The drug has already shown statistically significant results in a Phase 3 clinical trial.

In a Type A Meeting with the FDA convened by the company, the parties discussed the contents of a refusal to file letter previously issued by the agency regarding the NDA filing for HyBryte.

The FDA is requiring positive results from a second clinical study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication.

"While we are very disappointed by this delay, Soligenix and its clinical investigators remain committed to working with the FDA and advancing HyBryte to market for patients suffering with CTCL," stated Christopher Schaber, president and chief executive officer of Soligenix.

Based on the feedback, Soligenix ( SNGX ) plans to work with the agency to define the protocol and evaluate the feasibility of conducting the additional clinical trial.

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