How Far Will It Go? Soligenix, Inc. (NASDAQ:SNGX) Stock Extends Rally

Soligenix, Inc. (NASDAQ:SNGX)  continues to gain momentum on Thursday and is seeing a moderate gains in early morning session.

Market Reaction:

As of 10.41, SNGX stock moved up 6% to $1.24 with more than 3.26 million shares, compared to  its average volume of 971K shares. The stock has moved within a range of $1.2300 – 1.3400 after opening the trade at $1.3228.

Major Trigger:

Soligenix Receives Pediatric Investigational Plan Waiver for HyBryte™ in CTCL from the European Medicines Agency

Key Highlights:

• announced today that it has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for HyBryte™ (SGX301 or hypericin), which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL).
• As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining the Company’s strategy for investigation of the new medicinal products in the pediatric population.  In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children.  

Key Quote:

“This achievement is an important regulatory milestone as we move forward with marketing applications worldwide,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “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. With the support of key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, and key opinion leaders, we are moving towards marketing approval and commercialization of HyBryte™, with the initial focus on the U.S. market followed by a MAA submission in Europe shortly thereafter.”