Soligenix Stock Plummets After It Announces Not To Pursue Rolling US Application Submission For HyBryte

Soligenix Inc SNGX shares dropped during premarket after the company said it would not pursue a rolling marketing application submission for HyBryte (SGX301). Instead, it plans to submit the NDA in the first half of 2022.
The decision follows the company's discussions with the FDA regarding the HyBryte application submission.
Based on the discussions and given delays in manufacturing, in part caused by the global COVID-19 pandemic, Soligenix has decided to drop the rolling NDA submission at this time to provide additional supportive data for inclusion in the NDA filing.
The company sees potential FDA approval adjusted to the first half of 2023.
Recently, confirmatory data from its Phase 3 FLASH study was presented at the Society for Investigative Dermatology (SID) Virtual Meeting.
The presented data demonstrated the ability of HyBryte to treat both patch and plaque disease, including generating complete disease responses, while being associated with fewer and less severe adverse events than other currently approved skin-directed therapies for cutaneous T-cell lymphoma.
HyBryte (SGX301 or synthetic hypericin) is a novel photodynamic therapy utilizing safe, visible light to treat cutaneous T-cell lymphoma.
Price Action: SNGX shares fell 17.2% at $1.06 in the premarket trading on the last check Monday.