Shares of biotech firm Soligenix (NASDAQ:SNGX) dipped about 13% at the time of writing, following news that the FDA wants more positive data before accepting a New Drug Application (NDA) for the company’s HyBryte medication. HyBryte, a light-activated ointment, is designed to treat early-stage cutaneous T-cell lymphoma (CTCL) and has already demonstrated statistically significant results in a Phase 3 clinical trial.
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The FDA now requires positive outcomes from an additional clinical study beyond the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted. Soligenix’s president and CEO, Christopher Schaber, expressed disappointment over the delay but affirmed the company’s commitment to working with the FDA and getting HyBryte to market for CTCL patients.
A look at the past five trading days for SNGX stock shows that share prices were already in a decline prior to today’s announcement. As a result, investors are down over 21% during this timeframe.