Pharming Group NV (PHAR)

Sep 25, 2026

Pharming Group N.V. has announced that the U.S. FDA has accepted and granted Priority Review for its supplemental New Drug Application (sNDA) for lower doses of Joenja® (leniolisib). This sNDA seeks approval to treat children aged 4 years and older weighing between 13 kg and 27 kg with Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS). The PDUFA target action date for a decision is January 30, 2027, which, if approved, would expand Joenja's availability to a younger and lower-weight pediatric population.

Sep 17, 2026

Pharming Group (PHAR) recently received FDA approval to expand Joenja's pediatric label for children aged 4-11 with APDS. This expansion introduces new dosing options and is expected to boost Joenja's revenue, which saw a 40% year-over-year increase in Q2. However, the company faces challenges with its larger product, RUCONEST, which experienced a 10% revenue decline, raising questions about whether Joenja's growth can fully offset RUCONEST's weakness and lead to overall portfolio growth.

Sep 14, 2026

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