Data signals Tarlatamab: 10 Calculated Market Indicators · Vestango Data Signals DS-2026-06-002 Vestango · Data Signals vestango.com/data-intelligence → Data Signal · DS-2026-06-002 · Calculated Market Indicators Tarlatamab ES-SCLC:10 Calculated Market Intelligence Indicators Ten market indicators calculated from the Vestango intelligence corpus — regulatory timelines, clinical trial density, publication velocity, HTA coverage, safety signal burden, and CDx infrastructure readiness. Each number tells a different story about where this drug stands commercially in June 2026. Data date2026-06-07 Signal IDDS-2026-06-002 INNTarlatamab · ES-SCLC Corpus25,429 scored records SourceVestango Data & Intelligence 10 Calculated Indicators Market Intelligence — Derived Metrics Each indicator below quantifies a specific dimension of the tarlatamab commercial landscape as of June 2026 — from regulatory speed and HTA coverage to competitive trial pressure and diagnostic infrastructure readiness. 1Regulatory Speed 54% Faster than Industry Median — BTD to Traditional Approval Tarlatamab achieved Traditional FDA Approval in 25 months from Breakthrough Therapy Designation (Oct 2023 → Nov 2025). Industry median for BTD-to-approval in oncology: 54 months (FDA CDER BTD Program Annual Report 2023). Tarlatamab approval timeline is 54% shorter. Vestango corpus: 25 months. Benchmark: FDA CDER, Breakthrough Therapy Designation Program: 2023 Annual Report, median oncology BTD-to-approval = 54 months. 2Accelerated Approval Conversion 18 mo Accelerated → Traditional Approval Conversion Speed Tarlatamab converted Accelerated Approval (May 2024) to Traditional Approval (Nov 2025) in 18 months — versus typical oncology AA conversion of 36 months (FDA AA Program Annual Report 2023). Twice as fast as the standard pathway. Vestango corpus: Nov 2025 − May 2024 = 18 months. Benchmark: FDA Accelerated Approval Program Annual Report 2023, median oncology AA-to-full-approval = 36 months. 3Regulatory Arbitrage Window 7+ mo Minimum FDA–EMA Regulatory Lag (June 2026) EMA Marketing Authorisation remains pending as of data date — at least 7 months after FDA Traditional Approval (Nov 2025). Published FDA→EMA median lag for oncology BT drugs: 12–15 months (Putignano et al., J Pharm Policy Pract, 2022). Projected EU MA: H2 2026 – Q1 2027. Vestango corpus: data date Jun 2026 − FDA approval Nov 2025 = 7+ months. Benchmark: Putignano et al. (2022), EMA-FDA parallel procedures, median EU/US lag 12–15 months, J Pharm Policy Pract. 4HTA Coverage Gap 0 / 10 Positive HTA Reimbursement Decisions — June 2026 Zero of 10 monitored HTA agencies have issued a positive reimbursement recommendation. NICE rejected (Jul 2025). EUnetHTA JCA ongoing. 8 agencies: no decision on record. Despite US approval, positive HTA coverage = 0%. Positive decisions / Total agencies monitored = 0/10 = 0% 5Competitive Pressure Index 31.4× Landscape Trials per Direct Tarlatamab Trial (Recruiting) For every 1 direct tarlatamab trial (50 total), there are 31.4 other trials actively recruiting in the SCLC/DLL3 landscape (1,570 recruiting). Indicates substantial competitive clinical activity in the same therapeutic space. 1,570 recruiting trials / 50 direct tarlatamab trials = 31.4× 6Scientific Momentum 827 New Publications Per Year — 2024–2026 Annualised Rate 2,068 publications indexed from 2024 to mid-2026 (2.5 years) = 827 per year annualised — equivalent to 2.3 new publications per day. Indicates sustained and intensifying scientific engagement. 2,068 publications / 2.5 years = 827/yr = 2.3/day 7Safety Signal Density 14.5% Safety-Classified Signals as % of Total Signal Corpus 35 of 241 classified signals are safety-related (ICANS, CRS, interstitial lung disease). At 14.5%, this exceeds the typical oncology safety signal density for approved immunotherapies, indicating active pharmacovigilance requirements across all HTA submissions. 35 safety signals / 241 total signals × 100 = 14.5% 8CDx Infrastructure Gap 0% DLL3 CDx Coverage — EU Certified Manufacturer Screen 310 EU-certified medical device manufacturers screened against EUDAMED IVDR registry. DLL3-targeting companion diagnostic coverage: 0 of 310 manufacturers. No FDA-approved DLL3 CDx either. Global CDx infrastructure for patient selection = absent. DLL3 CDx approvals / 310 EU-certified manufacturers screened = 0/310 = 0% 9Literature Recency Index 23.6% Share of Total Literature Published in Last 2.5 Years 2,068 of 8,781 indexed publications appeared in 2024–mid-2026. At 23.6% recency share for a 2.5-year window, tarlatamab generates roughly 3× more annual literature than the historical baseline — a marker of high scientific and commercial priority. 2,068 recent pubs / 8,781 total × 100 = 23.6% in 2.5 years 10Evidence Curation Ratio 3.6% Top-Evidence Records as % of Total Scored Corpus Only 907 of 25,429 scored records (3.6%) passed the top-evidence threshold for inclusion in the curated intelligence layer. Each curated record carries an average of 1.6 verified source links. The 96.4% excluded provides the filtering depth behind each finding. 907 curated / 25,429 scored × 100 = 3.6% · avg 1,440/907 = 1.6 links/record Visual Summary Regulatory Timeline vs Industry Benchmarks Porównanie kluczowych kamieni milowych tarlatamab z medianą branżową dla onkologicznych leków z designacją Breakthrough Therapy. Regulatory Milestones — Months from Breakthrough Therapy Designation Tarlatamab vs industry median · Source: Vestango Data & Intelligence · DS-2026-06-002 Tarlatamab data: Vestango Tarlatamab Regulatory & Market Decision Intelligence Package, DS-2026-06-002 (BTD: Oct 2023, AA: May 2024, Traditional Approval: Nov 2025). Industry medians: (1,2) FDA CDER Breakthrough Therapy Designation Program Annual Report 2023; FDA Accelerated Approval Program Annual Report 2023. (3) Putignano et al., J Pharm Policy Pract, 2022 — EMA/FDA approval lag, median 12–15 months. External benchmarks are not part of the Vestango corpus and are cited independently. Composite Intelligence Interpretation The 10 indicators collectively describe a compound market paradox: exceptional regulatory speed (indicators 1–2) has outpaced HTA and diagnostic infrastructure readiness (indicators 4, 7–8). Tarlatamab achieved FDA approval 54% faster than the oncology median, yet as of June 2026 holds zero positive reimbursement decisions across 10 monitored markets and zero approved companion diagnostics globally. Simultaneously, the 31.4× competitive trial density (indicator 5) and 827 annual publications (indicator 6) signal that the scientific and commercial ecosystem around this target is intensifying — creating a window where intelligence on regulatory, HTA and CDx developments carries disproportionate decision value. Source: Vestango Life Sciences · Data & Intelligence · vestango.com/data-intelligence · Signal ID: DS-2026-06-002 · Data date: 2026-06-07 · © 2026 Vestango Life Sciences Sp. z o.o. All rights reserved. · For citation: Vestango Data Signals, DS-2026-06-002 (2026-06-07) Full Intelligence Package — Tarlatamab 25,429-record scored corpus · 907 curated records · 1,440 source links · 12 modules including full regulatory timeline, HTA evidence requirements, clinical trial landscape, CDx registry cross-reference, and 241 classified market signals. View Package →
