{"success":true,"data":{"pressRelease":{"id":"168392","rtpr_id":"nGNXbgd60p-20261014","ticker":"PHAR","exchange":"Euronext Amsterdam","all_tickers":["PHAR"],"title":"Pharming presents positive Phase II topline data for leniolisib in genetic PIDs with immune dysregulation at ESID 2026","author":"Globe Newswire","published_at":"2026-10-14T06:00:00.374Z","article_body":"* First clinical data for leniolisib in a larger group of PID participants\nbeyond APDS, supporting the potential of targeted PI3Kδ inhibition to address\nimmune dysregulation\n* Leniolisib was well-tolerated, with benefits observed across multiple\nmeasures of immune dysregulation, including improvement in lymphoproliferation\nand positive trends in lung and liver disease markers\n* All participants who completed the study elected to continue receiving\ntreatment in a long-term extension study\nLeiden, the Netherlands, October 14, 2026: Pharming (Euronext Amsterdam:\nPHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune\nand genetic diseases, today presented positive topline data from its Phase II\ntrial\n(https://www.globenewswire.com/Tracker?data=WPwUBS6okQQdf4VGOAfYSNhHnYpy-AlsiTb3pPKypBzhqMoptB17Ej0DQmThEaBUjNfsE5SgfZcqN3YJQZ_nsd6uBLXWPzv47KU-zZJjeGuayfMVsT_jVDgx2xHnQODyOktxd57Le-hILSUpwa0wGVmV2zNnv95Eq-7321SI5VM=)\nof leniolisib in genetically identifiable primary immunodeficiencies (PIDs)\nwith immune dysregulation linked to altered PI3Kδ signaling. The data,\naccepted as a late-breaking abstract, were presented as a poster at the 22nd\nBiennial Meeting of the European Society for Immunodeficiencies (ESID), taking\nplace October 14-17, 2026, in Maastricht, the Netherlands.\n\n“These data provide the first clinical evidence that leniolisib can produce\nimprovements across multiple manifestations of immune dysregulation in\nconditions beyond APDS, with encouraging signals in lymphoproliferation,\npulmonary function, and liver disease,” said Anurag Relan, Chief Medical\nOfficer of Pharming. “The consistent reductions in spleen volume in nearly\nall evaluable participants are particularly encouraging. Splenomegaly is a\nmeasurable sign of lymphoproliferation, and these reductions suggest\nleniolisib is acting on a core driver of the disease process. The trends in\npulmonary findings are also particularly noteworthy, as even small\nimprovements in progressive lung disease were not expected over such a short\ntreatment period.”\n\nThis trial is a single-arm, open-label, intra-patient dose-escalation Phase II\nstudy that enrolled 13 participants with genetically identifiable PIDs driven\nby variants in the CTLA4, SOCS1, NFKB1 or FAS genes. Nine of the 13\nparticipants also had a diagnosis of common variable immunodeficiency (CVID).\nParticipants received leniolisib twice daily for 20 weeks, escalating from 10\nmg (4 weeks) to 30 mg (4 weeks) to 70 mg (12 weeks). Key results include:\n* Safety: Leniolisib was generally well-tolerated across all 4 genotypes\nassociated with dysregulated PI3Kδ signaling. Safety findings were consistent\nwith the known disease profile, with infections as the most common adverse\nevents (AEs) observed, and no new safety signals identified. All\ntreatment-related AEs were Grade 1. Two study participants experienced serious\nAEs that were deemed unrelated to leniolisib. One participant, with a history\nof portal hypertension, discontinued treatment early due to acute hepatitis.\n* Spleen volume: Mean reduction from baseline of 26.4% (n=11), with reductions\nobserved in 10 of 11 evaluable participants.\n* Lymph nodes: Mean reduction from baseline of 33.7% in index lesion size\n(n=4), with reductions observed in all four evaluable participants.\n* Pulmonary function: Among participants with impaired gas exchange at\nbaseline (n=7), the percent predicted diffusing capacity of the lungs for\ncarbon monoxide (DLCO) increased by a mean of 8.0%. Consistent with this,\nCT-assessed interstitial lung disease scores also decreased in 4 of 5\nevaluable participants.\n* Liver: Improvement in liver stiffness in 2 of 3 participants with heightened\nstiffness at baseline. \n* All 12 participants who completed the study enrolled in the three-year\nextension study (NCT06990529\n(https://clinicaltrials.gov/study/NCT06990529?term=NCT06990529&viewType=Card&rank=1)).\nAdded Dr. Relan: “Together, these results reinforce our broader strategy of\nevaluating PI3Kδ inhibition across PIDs characterized by immune\ndysregulation, regardless of genetic cause. We look forward to reporting\ntopline results from our separate Phase II trial in CVID, expected in\nNovember, which will inform our plans for a potential registrational study in\nthe broader CVID population.”\n\nBased on estimated prevalence rates, these genetically identifiable PIDs and\nCVID with immune dysregulation represent a broader potential patient\npopulation than APDS, with estimated prevalence of approximately 7.5 patients\nper million for genetic PIDs and approximately 39 patients per million for\nCVID, including overlap between the genetic PID and CVID populations, compared\nwith approximately 1.5 patients per million for APDS.\n\nAbout leniolisib \nLeniolisib is an oral, selective phosphoinositide 3-kinase delta (PI3Kδ)\ninhibitor designed to address PI3Kδ-driven immune dysregulation across\nprimary immunodeficiencies (PIDs).\n\nLeniolisib, marketed under the brand name Joenja®, is approved and\ncommercially available in multiple countries for the treatment of activated\nphosphoinositide 3-kinase delta syndrome (APDS) an ultra-rare and progressive\nPID characterized by immune dysregulation and deficiency.\n\nBeyond APDS, leniolisib is being evaluated in clinical trials for additional\nPIDs characterized by PI3Kδ-driven immune dysregulation, including common\nvariable immunodeficiency (CVID). These PIDs share many of the same clinical\nmanifestations, including lymphoproliferation, autoimmunity, gastrointestinal\ndisease, and lung disease. The safety and efficacy of leniolisib have not been\nestablished for these investigational uses.\n\nAbout Pharming\nPharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) is a global\nbiotechnology company that develops and commercializes innovative medicines\nfor people living with rare immune and genetic diseases.\n\nWe combine specialized scientific, medical, regulatory and commercial\nexpertise to advance a focused portfolio of approved medicines and development\nprograms that address significant unmet medical needs. Guided by insights from\npatients and the wider rare disease community, we are dedicated to delivering\ninnovative therapies for some of the most challenging rare diseases.\n\nPharming is headquartered in Leiden, the Netherlands, with operations in the\nUnited States and Europe. \n\nFor more information, visit www.pharming.com and find us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=nGOGzYAdNsQlB0rAkbvVn769zvi-D_RqgOOEZPHj_7wDEMosU-tVedCwGDzu3hiWllp5X-VqceJF4_RUv488RGtNLSMF7hF3IUbg4_QFvvA=).\n\nFor further public information, contact:\nPharming\nMichael Levitan, VP Investor Relations & Capital Markets \nT: +1 (908) 705 1696 \nE: investor@pharming.com \n\nSaskia Mehring, Head of Corporate Communications \nT: +31 6 28 32 60 41 \nE: mailto:\n(https://www.globenewswire.com/Tracker?data=DO-kyKVsXQXarXSuVSWoWHyuxNKM2yAs5rwJTt7RBHrE4OTJNohyNC_FOvge4SRyA_J2tYglL2-UwffN_pKM5g==)media.relations@pharming.com\n\nMedia Relations \nJulia Deutsch (Lyra Strategic Advisory on behalf of Pharming)\nE: JDeutsch@lyraadvisory.com\n\nNetherlands: Leon Melens (LifeSpring Life Sciences Communication on behalf of\nPharming) \nT: +31 6 53 81 64 27 \n\nForward-looking Statements \nThis press release may contain forward-looking statements. Forward-looking\nstatements are statements of future expectations that are based on\nmanagement’s current expectations and assumptions and involve known and\nunknown risks and uncertainties that could cause actual results, performance,\nor events to differ materially from those expressed or implied in these\nstatements. These forward-looking statements are identified by their use of\nterms and phrases such as “aim”, “ambition”, ‘‘anticipate’’,\n‘‘believe’’, ‘‘could’’, ‘‘estimate’’,\n‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’,\n“milestones”, ‘‘objectives’’, ‘‘outlook’’,\n‘‘plan’’, ‘‘probably’’, ‘‘project’’,\n‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’,\n‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples\nof forward-looking statements may include statements with respect to timing\nand progress of Pharming's preclinical studies and clinical trials of its\nproduct candidates, Pharming's clinical and commercial prospects, and\nPharming's expectations regarding its projected working capital requirements\nand cash resources, which statements are subject to a number of risks,\nuncertainties and assumptions, including, but not limited to the scope,\nprogress and expansion of Pharming's clinical trials and ramifications for the\ncost thereof; and clinical, scientific, regulatory, commercial, competitive\nand technical developments. In light of these risks and uncertainties, and\nother risks and uncertainties that are described in Pharming's 2025 Annual\nReport and the Annual Report on Form 20-F for the year ended December 31,\n2025, filed with the U.S. Securities and Exchange Commission, the events and\ncircumstances discussed in such forward-looking statements may not occur, and\nPharming's actual results could differ materially and adversely from those\nanticipated or implied thereby. All forward-looking statements contained in\nthis press release are expressly qualified in their entirety by the cautionary\nstatements contained or referred to in this section. Readers should not place\nundue reliance on forward-looking statements. Any forward-looking statements\nspeak only as of the date of this press release and are based on information\navailable to Pharming as of the date of this release. Pharming does not\nundertake any obligation to publicly update or revise any forward-looking\nstatement as a result of new information, future events or other information.\n\nInside Information\nThis press release relates to the disclosure of information that qualifies, or\nmay have qualified, as inside information within the meaning of Article 7(1)\nof the EU Market Abuse Regulation.\n\nAttachment\n*     Pharming presents Phase II topline data leniolisib PIDs_EN_14OCT2026\n(https://ml-eu.globenewswire.com/Resource/Download/f88228a2-e8b7-4c24-9fc2-e519942e59e7)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f164672f-d67c-41d2-9c79-46caee419077)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbgd60p-20261014","title":"Pharming presents positive Phase II topline data for leniolisib in genetic PIDs with immune dysregulation at ESID 2026","author":"Globe Newswire","ticker":"PHAR","created":"2026-10-14T06:00:00.374Z","tickers":["PHAR"],"exchange":"Euronext Amsterdam","article_body":"* First clinical data for leniolisib in a larger group of PID participants\nbeyond APDS, supporting the potential of targeted PI3Kδ inhibition to address\nimmune dysregulation\n* Leniolisib was well-tolerated, with benefits observed across multiple\nmeasures of immune dysregulation, including improvement in lymphoproliferation\nand positive trends in lung and liver disease markers\n* All participants who completed the study elected to continue receiving\ntreatment in a long-term extension study\nLeiden, the Netherlands, October 14, 2026: Pharming (Euronext Amsterdam:\nPHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune\nand genetic diseases, today presented positive topline data from its Phase II\ntrial\n(https://www.globenewswire.com/Tracker?data=WPwUBS6okQQdf4VGOAfYSNhHnYpy-AlsiTb3pPKypBzhqMoptB17Ej0DQmThEaBUjNfsE5SgfZcqN3YJQZ_nsd6uBLXWPzv47KU-zZJjeGuayfMVsT_jVDgx2xHnQODyOktxd57Le-hILSUpwa0wGVmV2zNnv95Eq-7321SI5VM=)\nof leniolisib in genetically identifiable primary immunodeficiencies (PIDs)\nwith immune dysregulation linked to altered PI3Kδ signaling. The data,\naccepted as a late-breaking abstract, were presented as a poster at the 22nd\nBiennial Meeting of the European Society for Immunodeficiencies (ESID), taking\nplace October 14-17, 2026, in Maastricht, the Netherlands.\n\n“These data provide the first clinical evidence that leniolisib can produce\nimprovements across multiple manifestations of immune dysregulation in\nconditions beyond APDS, with encouraging signals in lymphoproliferation,\npulmonary function, and liver disease,” said Anurag Relan, Chief Medical\nOfficer of Pharming. “The consistent reductions in spleen volume in nearly\nall evaluable participants are particularly encouraging. Splenomegaly is a\nmeasurable sign of lymphoproliferation, and these reductions suggest\nleniolisib is acting on a core driver of the disease process. The trends in\npulmonary findings are also particularly noteworthy, as even small\nimprovements in progressive lung disease were not expected over such a short\ntreatment period.”\n\nThis trial is a single-arm, open-label, intra-patient dose-escalation Phase II\nstudy that enrolled 13 participants with genetically identifiable PIDs driven\nby variants in the CTLA4, SOCS1, NFKB1 or FAS genes. Nine of the 13\nparticipants also had a diagnosis of common variable immunodeficiency (CVID).\nParticipants received leniolisib twice daily for 20 weeks, escalating from 10\nmg (4 weeks) to 30 mg (4 weeks) to 70 mg (12 weeks). Key results include:\n* Safety: Leniolisib was generally well-tolerated across all 4 genotypes\nassociated with dysregulated PI3Kδ signaling. Safety findings were consistent\nwith the known disease profile, with infections as the most common adverse\nevents (AEs) observed, and no new safety signals identified. All\ntreatment-related AEs were Grade 1. Two study participants experienced serious\nAEs that were deemed unrelated to leniolisib. One participant, with a history\nof portal hypertension, discontinued treatment early due to acute hepatitis.\n* Spleen volume: Mean reduction from baseline of 26.4% (n=11), with reductions\nobserved in 10 of 11 evaluable participants.\n* Lymph nodes: Mean reduction from baseline of 33.7% in index lesion size\n(n=4), with reductions observed in all four evaluable participants.\n* Pulmonary function: Among participants with impaired gas exchange at\nbaseline (n=7), the percent predicted diffusing capacity of the lungs for\ncarbon monoxide (DLCO) increased by a mean of 8.0%. Consistent with this,\nCT-assessed interstitial lung disease scores also decreased in 4 of 5\nevaluable participants.\n* Liver: Improvement in liver stiffness in 2 of 3 participants with heightened\nstiffness at baseline. \n* All 12 participants who completed the study enrolled in the three-year\nextension study (NCT06990529\n(https://clinicaltrials.gov/study/NCT06990529?term=NCT06990529&viewType=Card&rank=1)).\nAdded Dr. Relan: “Together, these results reinforce our broader strategy of\nevaluating PI3Kδ inhibition across PIDs characterized by immune\ndysregulation, regardless of genetic cause. We look forward to reporting\ntopline results from our separate Phase II trial in CVID, expected in\nNovember, which will inform our plans for a potential registrational study in\nthe broader CVID population.”\n\nBased on estimated prevalence rates, these genetically identifiable PIDs and\nCVID with immune dysregulation represent a broader potential patient\npopulation than APDS, with estimated prevalence of approximately 7.5 patients\nper million for genetic PIDs and approximately 39 patients per million for\nCVID, including overlap between the genetic PID and CVID populations, compared\nwith approximately 1.5 patients per million for APDS.\n\nAbout leniolisib \nLeniolisib is an oral, selective phosphoinositide 3-kinase delta (PI3Kδ)\ninhibitor designed to address PI3Kδ-driven immune dysregulation across\nprimary immunodeficiencies (PIDs).\n\nLeniolisib, marketed under the brand name Joenja®, is approved and\ncommercially available in multiple countries for the treatment of activated\nphosphoinositide 3-kinase delta syndrome (APDS) an ultra-rare and progressive\nPID characterized by immune dysregulation and deficiency.\n\nBeyond APDS, leniolisib is being evaluated in clinical trials for additional\nPIDs characterized by PI3Kδ-driven immune dysregulation, including common\nvariable immunodeficiency (CVID). These PIDs share many of the same clinical\nmanifestations, including lymphoproliferation, autoimmunity, gastrointestinal\ndisease, and lung disease. The safety and efficacy of leniolisib have not been\nestablished for these investigational uses.\n\nAbout Pharming\nPharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) is a global\nbiotechnology company that develops and commercializes innovative medicines\nfor people living with rare immune and genetic diseases.\n\nWe combine specialized scientific, medical, regulatory and commercial\nexpertise to advance a focused portfolio of approved medicines and development\nprograms that address significant unmet medical needs. Guided by insights from\npatients and the wider rare disease community, we are dedicated to delivering\ninnovative therapies for some of the most challenging rare diseases.\n\nPharming is headquartered in Leiden, the Netherlands, with operations in the\nUnited States and Europe. \n\nFor more information, visit www.pharming.com and find us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=nGOGzYAdNsQlB0rAkbvVn769zvi-D_RqgOOEZPHj_7wDEMosU-tVedCwGDzu3hiWllp5X-VqceJF4_RUv488RGtNLSMF7hF3IUbg4_QFvvA=).\n\nFor further public information, contact:\nPharming\nMichael Levitan, VP Investor Relations & Capital Markets \nT: +1 (908) 705 1696 \nE: investor@pharming.com \n\nSaskia Mehring, Head of Corporate Communications \nT: +31 6 28 32 60 41 \nE: mailto:\n(https://www.globenewswire.com/Tracker?data=DO-kyKVsXQXarXSuVSWoWHyuxNKM2yAs5rwJTt7RBHrE4OTJNohyNC_FOvge4SRyA_J2tYglL2-UwffN_pKM5g==)media.relations@pharming.com\n\nMedia Relations \nJulia Deutsch (Lyra Strategic Advisory on behalf of Pharming)\nE: JDeutsch@lyraadvisory.com\n\nNetherlands: Leon Melens (LifeSpring Life Sciences Communication on behalf of\nPharming) \nT: +31 6 53 81 64 27 \n\nForward-looking Statements \nThis press release may contain forward-looking statements. Forward-looking\nstatements are statements of future expectations that are based on\nmanagement’s current expectations and assumptions and involve known and\nunknown risks and uncertainties that could cause actual results, performance,\nor events to differ materially from those expressed or implied in these\nstatements. These forward-looking statements are identified by their use of\nterms and phrases such as “aim”, “ambition”, ‘‘anticipate’’,\n‘‘believe’’, ‘‘could’’, ‘‘estimate’’,\n‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’,\n“milestones”, ‘‘objectives’’, ‘‘outlook’’,\n‘‘plan’’, ‘‘probably’’, ‘‘project’’,\n‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’,\n‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples\nof forward-looking statements may include statements with respect to timing\nand progress of Pharming's preclinical studies and clinical trials of its\nproduct candidates, Pharming's clinical and commercial prospects, and\nPharming's expectations regarding its projected working capital requirements\nand cash resources, which statements are subject to a number of risks,\nuncertainties and assumptions, including, but not limited to the scope,\nprogress and expansion of Pharming's clinical trials and ramifications for the\ncost thereof; and clinical, scientific, regulatory, commercial, competitive\nand technical developments. In light of these risks and uncertainties, and\nother risks and uncertainties that are described in Pharming's 2025 Annual\nReport and the Annual Report on Form 20-F for the year ended December 31,\n2025, filed with the U.S. Securities and Exchange Commission, the events and\ncircumstances discussed in such forward-looking statements may not occur, and\nPharming's actual results could differ materially and adversely from those\nanticipated or implied thereby. All forward-looking statements contained in\nthis press release are expressly qualified in their entirety by the cautionary\nstatements contained or referred to in this section. Readers should not place\nundue reliance on forward-looking statements. Any forward-looking statements\nspeak only as of the date of this press release and are based on information\navailable to Pharming as of the date of this release. Pharming does not\nundertake any obligation to publicly update or revise any forward-looking\nstatement as a result of new information, future events or other information.\n\nInside Information\nThis press release relates to the disclosure of information that qualifies, or\nmay have qualified, as inside information within the meaning of Article 7(1)\nof the EU Market Abuse Regulation.\n\nAttachment\n*     Pharming presents Phase II topline data leniolisib PIDs_EN_14OCT2026\n(https://ml-eu.globenewswire.com/Resource/Download/f88228a2-e8b7-4c24-9fc2-e519942e59e7)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f164672f-d67c-41d2-9c79-46caee419077)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-14T06:00:00.553091443Z","server_sent_at_ms":1791957600553},"received_at":"2026-10-14T06:00:00.619Z","source_url":null},"analysis":{"id":"156659","press_release_id":"168392","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["single-arm, open-label trial without control group; small sample sizes per endpoint (n=4-11)","one participant discontinued due to acute hepatitis (deemed unrelated)"],"eventType":"clinical_trial","narrative":"Pharming presented positive Phase II topline data for leniolisib in genetically identifiable primary immunodeficiencies with PI3Kδ-driven immune dysregulation, at the ESID 2026 meeting in Maastricht.\n\nThe 13-participant, open-label study showed a 26.4% mean reduction in spleen volume, 33.7% reduction in lymph node index lesions, and an 8.0% mean DLCO improvement in lung-function-impaired patients, with no new safety signals. All 12 completers elected to continue in a three-year extension study.\n\nThe data support label expansion beyond APDS into a broader PID and CVID population; topline results from a separate Phase II CVID trial are expected in November and will inform plans for a potential registrational study.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Leniolisib shows first clinical signals beyond APDS, expanding Pharming's rare-disease TAM ahead of a November CVID Phase II readout."},"keyFigures":{"drugName":"leniolisib (Joenja)","phaseOfTrial":"Phase II","customDimensions":{"extension_enrollment":"all 12 completers enrolled in three-year extension","participants_enrolled":13,"dlco_mean_increase_pct":8,"treatment_duration_weeks":20,"spleen_volume_mean_reduction_pct":26.4,"lymph_node_index_lesion_mean_reduction_pct":33.7}},"quotedText":"these results reinforce our broader strategy of evaluating PI3Kδ inhibition across PIDs characterized by immune dysregulation, regardless of genetic cause","namedEntities":{"people":[{"name":"Anurag Relan","role":"Chief Medical Officer"},{"name":"Michael Levitan","role":"VP Investor Relations & Capital Markets"}],"products":["leniolisib","Joenja"],"companies":[{"name":"Pharming Group N.V.","ticker":"PHAR","relationship":"filer"},{"name":"European Society for Immunodeficiencies","relationship":"conference host"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive Phase II topline data for leniolisib in PIDs beyond APDS, expanding the addressable population (~7.5-39 patients/million vs 1.5 for APDS). Early-stage, single-arm, open-label data limits certainty, but it de-risks the label-expansion strategy ahead of a CVID Phase II readout in November."},"tickerRelevance":{"others":[],"primary":"PHAR"},"globalImportance":38,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap biotech","eventGravity":"positive Phase II topline, early-stage label-expansion data","upcomingCatalyst":"CVID Phase II topline expected November 2026"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Pharming presented positive Phase II topline data for leniolisib in genetically identifiable primary immunodeficiencies with PI3Kδ-driven immune dysregulation, at the ESID 2026 meeting in Maastricht.\n\nThe 13-participant, open-label study showed a 26.4% mean reduction in spleen volume, 33.7% reduction in lymph node index lesions, and an 8.0% mean DLCO improvement in lung-function-impaired patients, with no new safety signals. All 12 completers elected to continue in a three-year extension study.\n\nThe data support label expansion beyond APDS into a broader PID and CVID population; topline results from a separate Phase II CVID trial are expected in November and will inform plans for a potential registrational study.","key_figures":{"drugName":"leniolisib (Joenja)","phaseOfTrial":"Phase II","customDimensions":{"extension_enrollment":"all 12 completers enrolled in three-year extension","participants_enrolled":13,"dlco_mean_increase_pct":8,"treatment_duration_weeks":20,"spleen_volume_mean_reduction_pct":26.4,"lymph_node_index_lesion_mean_reduction_pct":33.7}},"named_entities":{"people":[{"name":"Anurag Relan","role":"Chief Medical Officer"},{"name":"Michael Levitan","role":"VP Investor Relations & Capital Markets"}],"products":["leniolisib","Joenja"],"companies":[{"name":"Pharming Group N.V.","ticker":"PHAR","relationship":"filer"},{"name":"European Society for Immunodeficiencies","relationship":"conference host"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T06:00:12.005Z","global_importance":38,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap biotech","eventGravity":"positive Phase II topline, early-stage label-expansion data","upcomingCatalyst":"CVID Phase II topline expected November 2026"}},"durationMs":6968,"modelName":"glm-5.3-flashx"}}