EU Nears Approval for Pharming's Joenja® as CHMP Issues Positive Opinion for APDS Treatment
Summary
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Pharming Group's Joenja® (leniolisib) for the treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) in adult and pediatric patients 12 years and older. This follows the recent regulatory approval for Joenja in Japan earlier this week, highlighting strong global progress for the drug. A final decision from the European Commission is expected within approximately two months. If approved, Joenja would be the first treatment for APDS in the EU, opening a significant new market for Pharming and addressing a high unmet medical need for this rare primary immunodeficiency. This positive opinion is a critical step towards commercialization in a major market and is a strong positive catalyst for the stock.
At the time of this announcement, PHAR was trading at $16.31 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.1B. The 52-week trading range was $7.50 to $21.34. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.