Soligenix (NASDAQ:SNGX) slumped in Tuesday’s early deals after revealing its cancer drug has been knocked back by the US Food and Drug Administration.
The company, in a statement, told investors that it has received a Refusal to File (RTF) letter from the FDA for its HyBryte new drug application (NDA).
Soligenix (NASDAQ:SNGX) had sought approval to use HyBryte to treat a rare cancer, early-stage cutaneous T-cell lymphoma (CTCL) which affects around 25,000 patients in the US.
According to the FDA, the NDA was not sufficiently complete for it to review.
"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 CEO Christopher Schaber.
"We remain focused on advancing HyBryte as a potential new first-in-class treatment option for the CTCL community of patients, families and healthcare professionals."
In New York, Soligenix stock fell around 26% to trade at US$4.31 – after initially seeing a drop of more than 30% in premarket exchanges.