Pharming Group’s Leniolisib Gains FDA Approval for Pediatric Use, Expanding Market Potential
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Pharming Group’s leniolisib has received FDA approval for pediatric use, targeting children aged 4 to 11 with activated phosphoinositide 3-kinase delta syndrome (APDS). This approval, supported by Phase 3 trial results, opens significant market opportunities due to the lack of existing treatments for this age group. Analyst Joseph Pantginis has issued a Buy rating, citing the drug's potential efficacy and safety, along with Pharming's global expansion efforts. The PDUFA date is set for January 31, 2026, which could enhance leniolisib's commercial prospects.
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