11:00 AM EST, 12/11/2024 (MT Newswires) -- Pharming Group ( PHAR ) reported Wednesday positive phase III data for its investigational drug leniolisib in children aged between four and 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.
The biopharmaceutical company said the data was consistent with improvements seen in a previously reported randomized controlled trial in adolescent and adult patients.
The study showed improvement in lymphoproliferation and abnormal immunophenotype from baseline to 12 weeks in all patients who completed the treatment period, the company said.
Pharming Group ( PHAR ) said it intends to include data from the trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS starting next year.
The company's shares were up 6.6% in recent trading.
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