FDA Accepts Pharming's Joenja Resubmission for Younger APDS Patients, Sets October PDUFA Date
Summary
The FDA has accepted Pharming's resubmitted sNDA for Joenja to treat children aged 4 to 11 with APDS, setting a PDUFA target action date of October 24, 2026. This follows a Complete Response Letter received earlier this year and is a crucial step towards expanding the drug's market in the US. Joenja is already approved for patients 12 years and older in the US, and the company recently secured EU marketing authorization and Japanese approval for the drug. Expanding the label to this younger pediatric population could materially increase Joenja's revenue potential.
At the time of this announcement, PHAR was trading at $12.24 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $883.3M. The 52-week trading range was $9.54 to $21.34. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.