Pharming Group (PHAR) said Friday a European Medicines Agency committee recommended marketing authorization for its Joenja drug to treat activated phosphoinositide 3-kinase delta syndrome, a rare immunodeficiency in patients aged 12 years and above.
The European Commission is expected to issue a final decision within about two months.
The positive recommendation is supported by data from phase 2/3 clinical trial demonstrating a "statistically significant" impact on immune dysregulation and immunodeficiency, the company said.
Pharming shares were up 5.4% in premarket activity.