Pharming Group N.V. (PHAR) Form 6-K — Sep 25, 2026
Pharming Group N.V. announced that the U.S. FDA has accepted its sNDA for lower doses of Joenja (leniolisib) to treat children aged 4 and older weighing 13 kg to 27 kg with APDS, a rare primary immunodeficiency. The application was granted Priority Review with a PDUFA target action date of January 30, 2027, supported by positive open-label Phase III data showing reduced lymphadenopathy and increased naive B cells in children aged 4 to 11 years.
Key figures
- Pdufa date
- 2027-01-30
- Target age
- 4 years and older
- Apds prevalence per million
- 1-2
- Target patient weight range kg
- 13-27 kg
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