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CT-P51 is the Celltrion biosimilar to Merck KEYTRUDA (pembrolizumab), running a global Ph3 equivalence study in 606 patients with metastatic NSCLC; Keytruda is the largest drug in the world at roughly $25B of annual sales, so this is the single most valuable biosimilar in the pipeline. The denosumab biosimilar is CT-P41 (STOBOCLO / OSENVELT), which the FDA approved 2025-02-28, designated interchangeable 2025-10-29 and the EC authorised in Feb 2025 -- it is already carried as commercial in this config, so it could not also be a 2026 approval catalyst. Previous title: Pembrolizumab (Keytruda) biosimilar CT-P51 -- global Ph3 in metastatic NSCLC (n=606) reading out toward US/EU filings; RETITLED Aug 18 2026, this catalyst previously said denosumab which was wrong | ROLLED 2026-10-02: per Pearce IP (Jul 6 2026) + Youth Daily KR coverage of the Sep 5 2026 FDA amendment; secondary sources, date-only change.","failTP":162176.52,"successTP":162176.758,"baseTP":162176.659,"swingPct":0,"successMove":0,"failMove":0,"yourPoS":81,"expectedReturn":0,"daysOut":null,"materiality":0}],"salesM2025":0,"lenses":{"comparable":124307.3,"eeRel":0.5172},"readouts":[{"a":"ct_p53","ind":"ms","ds":"2027-06-30","area":"immunology.demyelinating.multiple_sclerosis","endpoint":"arr_reduction_pct","unit":"%","src":"class","med":38.8055757,"lo":-12.0987096,"hi":90,"pBeatBest":0.15395,"bestDrug":"natalizumab","bestValue":68}]},"CGEM":{"name":"Cullinan Therapeutics","subtitle":"REZILIENT3 1L ex20ins Ph3: PFS HR 0.50 (14.5 vs 8.5mo, WCLC Sep'26), OS immature; zipalertinib 2L PDUFA Feb 27'27 (Taiho 50/50); CLN-978 + velinotamig TCE autoimmune; cash $356M","currency":"USD","country":"US","region":"AMERICAS.US","archetype":"clinical_stage","private":false,"sharesOut":61.46,"netCashLocal":356,"cashPS":5.7924,"tps":{"mega_bear":10.88,"bear":18.18,"base":25.79,"bull":35.36,"psychedelic_bull":46.05},"weightedTP":25.99,"meta":{"areas":["oncology.lung.nsclc.egfr","oncology","oncology.lung","oncology.lung.nsclc","immunology.autoimmune.sle","immunology","immunology.autoimmune","immunology.inflammatory_systemic.rheumatoid_arthritis","immunology.inflammatory_systemic","oncology.leukemia.aml.flt3_mut","oncology.leukemia","oncology.leukemia.aml"],"modalities":["small_molecule.kinase.egfr_ex20","small_molecule","small_molecule.kinase","biologic.antibody.bispecific.cd19_cd3","biologic","biologic.antibody","biologic.antibody.bispecific","biologic.antibody.bispecific.flt3_cd3","biologic.antibody.bispecific.bcma_cd3"],"focus":[{"area":"immunology.inflammatory_systemic.rheumatoid_arthritis","purity":83},{"area":"immunology.autoimmune.sle","purity":66},{"area":"immunology.inflammatory_systemic","purity":42},{"area":"immunology.autoimmune","purity":33},{"area":"oncology.lung.nsclc.egfr","purity":23},{"area":"oncology.lung","purity":23},{"area":"oncology.lung.nsclc","purity":23},{"area":"oncology.leukemia.aml.flt3_mut","purity":2},{"area":"oncology.leukemia","purity":2},{"area":"oncology.leukemia.aml","purity":2}],"focusWtd":[{"area":"oncology.lung.nsclc.egfr","purity":54},{"area":"oncology.lung","purity":54},{"area":"oncology.lung.nsclc","purity":54},{"area":"immunology.inflammatory_systemic.rheumatoid_arthritis","purity":51},{"area":"immunology.autoimmune.sle","purity":38},{"area":"immunology.inflammatory_systemic","purity":26},{"area":"immunology.autoimmune","purity":19},{"area":"oncology.leukemia.aml.flt3_mut","purity":1},{"area":"oncology.leukemia","purity":1},{"area":"oncology.leukemia.aml","purity":1}],"focusSOM":[{"area":"oncology.lung.nsclc.egfr","purity":57},{"area":"oncology.lung","purity":57},{"area":"oncology.lung.nsclc","purity":57},{"area":"immunology.inflammatory_systemic.rheumatoid_arthritis","purity":47},{"area":"immunology.autoimmune.sle","purity":36},{"area":"immunology.inflammatory_systemic","purity":23},{"area":"immunology.autoimmune","purity":18},{"area":"oncology.leukemia.aml.flt3_mut","purity":2},{"area":"oncology.leukemia","purity":2},{"area":"oncology.leukemia.aml","purity":2}],"phase":"phase3","rare":false,"pediatric":false,"rarePurity":0,"rarePurityWtd":0,"optionality":149,"totalTAM":74.892,"totalWTD":30.0636038},"catalysts":[{"date":"August 12, 2026","dateSort":"2026-08-12","asset":"zipalertinib","indication":"zip_nsclc_ex20","title":"REPORTED: REZILIENT3 1L EGFR ex20ins NSCLC Ph3 HIT -- met PFS primary at planned interim analysis (n=285); IDMC recommended unblinding","type":"phase3_data","binary":true,"fail_pos":30,"fail_apr":35,"success_pos":85,"success_apr":88,"_source":"https://www.taihooncology.com/us/news/zipalertinib-plus-chemotherapy-meets-primary-endpoint-of-progression-free-survival-in-planned-interim-analysis-of-phase-3-rezilient3-trial-in-first-line-egfr-exon-20-insertion-mutation-non-small-cell-lung-cancer/","_confidence":"high","_outcome":"success","_outcomeRationale":"Zipalertinib + platinum chemo met the primary endpoint of PFS at a planned interim analysis in previously untreated locally advanced/metastatic EGFR ex20ins NSCLC (n=285 randomised); statistically significant and clinically meaningful PFS benefit with manageable safety; IDMC recommended unblinding while the trial continues. 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