Pharming Group to Present Eight Abstracts on Leniolisib at CIS Congress
Pharming Group announced on Thursday a series of presentations at the annual congress of the Clinical Immunology Society (CIS), taking place from May 6 to May 9 in New Orleans. These presentations will focus on the study results of leniolisib in patients with rare immunological disorders, particularly APDS syndrome.
Eight Presentations Focused on Leniolisib and Primary Immunodeficiencies
Pharming and its collaborators will present eight communications covering several clinical areas. Among these are the interim results of a long-term extension study of leniolisib in pediatric patients aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
Other presentations will focus on the clinical experience of leniolisib in expanded access for treating immune dysregulation in patients with common variable immune deficiencies (CVID) and CVID-like disorders. The program also includes a presentation on the demographic and clinical characteristics of pediatric APDS syndrome, as well as data on symptoms reported by patients and caregivers.
Two Ongoing Phase II Trials for CVID and Other Immunodeficiencies
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Two phase II clinical trials (NCT06897358 and NCT06549114) are currently underway to assess the safety and tolerability of leniolisib in patients with CVID and primary immunodeficiencies with immune dysregulation beyond APDS syndrome.
Anurag Relan, Medical Director at Pharming, commented, 'We are pleased to present data at CIS that advances the understanding of APDS syndrome and other primary immunodeficiencies characterized by immune dysregulation. Observations from clinical experience support ongoing clinical trials evaluating leniolisib in CVID and CVID-like disorders, and we look forward to the results in the second half of this year.'
SectorPharmacie et biotechnologies›Biotechnologies
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Context
Period
Period: T3 2026
Key reported figures
Revenue: 117,6 millions de dollars
Quarterly revenue: 117,6 millions de dollars
Revenue growth: 21 %
Guidance from the release
Tightened 2026 total revenue guidance to between US$380 million and US$390 million from prior US$375 million to US$395 million
Risks mentioned
Joenja revenue growth was partly driven by temporary benefit from ordering patterns in other international markets
RUCONEST third quarter revenue includes an early seasonal increase in channel inventory at a single U.S. specialty pharmacy customer, following significant drawdowns earlier in the year
Napazimone (KL1333): enrollment in the pivotal FALCON trial now expected to complete in the first half of 2027 (about 145 of 180 subjects by end-2026), with topline results approximately one year after completion of enrollment
Opportunities identified
RUCONEST stabilization and continued recovery of demand in the US (third quarter revenue of about US$93.8 million, +14% year-on-year and +30% versus the second quarter of 2026)
Joenja strong growth driven by launches in Germany, Japan and continued penetration in the U.K.
Substantial growth potential for Joenja with estimated CVID with immune dysregulation prevalence of 39 patients per million vs 1.5 for APDS
Outlook / guidance
Expected revenue: 385 millions de dollars
Management commentary: Tightened 2026 total revenue guidance to between US$380 million and US$390 million (1% to 4% growth) from prior US$375 million to US$395 million (0% to 5% growth)
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