Pharming Launches Joenja In Japan For APDS
(RTTNews) - Pharming Group (PHAR) announced the commercial launch of Joenja (leniolisib) in Japan for adult and children aged 4 years and older with activated PI3K delta syndrome, following its inclusion in NHI price list.
Activated PI3K delta syndrome (APDS) is a rare primary immunodeficiency caused by genetic variants in the PI3Kd (phosphoinositide 3-kinase delta) pathway, leading to recurrent infections, immune dysregulation, and increased risk of lymphoma.
Joenja (leniolisib), and oral PI3Kd inhibitor, was approved based on results from a randomized, placebo-controlled Phase III trial that met its coprimary endpoints, showing statistically significant improvements in immune function. Long-term open label extension data further supported its safety and tolerability.
Pharming CFO Leverne Marsh, commented that the launch represents "a major milestone in expanding access to Joenja globally, particularly for younger patients in Japan who previously had no approved treatment options." The approval was granted earlier this year by Japan's Ministry of Health, Labour and Welfare, with OrphanPacific, Inc. serving as the local marketing authorization holder and distributer partner.
PHAR has traded between $9.62 and $21.34 over the past year. The stock closed Wednesday's trading at $11.83, down 3.27%. During overnight trading the stock is at $12.20, up 3.13%.
