SNGX - Soligenix soars 13% after securing PIP waiver for HyBryte in blood cancer in Europe

Soligenix (SNGX) jumps 13% premarket after receiving a Pediatric Investigation Plan ((PIP)) waiver from the EMA for HyBryte (SGX301 or hypericin), which has recently and successfully concluded a Phase 3 study for the treatment of early stage cutaneous T-cell lymphoma ((CTCL)). As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining the Company's strategy for investigation of the new medicinal products in the pediatric population. "The PIP waiver allows us to work towards advancing a marketing authorization application ((MAA)) with EMA in a more cost-effective manner since we will not need to expend significant time and resource to conduct a pediatric clinical study in the European Union," stated Christopher J. Schaber, PhD, President and CEO.

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Soligenix soars 13% after securing PIP waiver for HyBryte in blood cancer in Europe