- The stock price of Soligenix, Inc. (NASDAQ: SNGX) increased by over 15% pre-market. This is why it happened.
The stock price of Soligenix, Inc. (NASDAQ: SNGX) – a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need – increased by over 15% pre-market. Investors are responding positively to the company anouncing 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 the investigation of the new medicinal products in the pediatric population. And in some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when the 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.
“This achievement is an important regulatory milestone as we move forward with marketing applications worldwide. 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.”
— Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.