Provenance Record

Clear, well-structured News piece (829 words). Overview/What We Know/Safety Signals/Competitive Context/What We Don't Know structure is appropriate for a regulatory-milestone story. Technical depth on the IGF-1R mechanism and cross-trial framing is accurate and measured.

All 4 sources read and verified. IMPORTANT — snapshot archival limitation: 3 of 4 source snapshots failed to capture content. source-0.html.gz (BioSpace) captured cleanly (HTTP 200) and verifies the full regulatory/quote layer. source-1.html.gz (PMC12545473, THRIVE) and source-3.html.gz (PMC7334856, teprotumumab review) both returned a reCAPTCHA browser-check interstitial despite HTTP 200, so no article text was archived. source-2 (academic.oup.com, THRIVE-2) returned HTTP 403 with a null snapshot. As a last resort I verified all three failed sources against their live URLs via WebFetch, and EVERY clinical specific matched verbatim. BioSpace snapshot: confirms June 30, 2026 PDUFA target action date, Priority Review (shortens to six months from ten), Breakthrough Therapy Designation May 2025, the 'five-infusion treatment course enabling patients to complete treatment in 12 weeks' quote, the 'intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody' description, the 'two of the largest phase 3 clinical trials conducted in TED to date' quote, the 'met the primary and all secondary endpoints of each study' quote, and the Steve Mahoney President-and-CEO quote — all verbatim with correct speaker and title. THRIVE (PMC12545473) live: 113 randomized (veligrotug n=75 / placebo n=38), '5 IV infusions 3 weeks apart of either 10 mg/kg', proptosis PRR 70% vs 5% (p<0.0001), diplopia complete resolution 54% (27/50) vs 12% (3/26), AEs 66 (88%) vs 24 (63%) with 4 serious AEs all unrelated, hearing impairment 12 (16%) vs 4 (11%) — all match. THRIVE-2 (academic.oup.com) live: 188 randomized (veli n=125 / placebo n=63), Hertel PRR 56% vs 8% (p<0.0001), mean reduction 2.34 mm vs 0.46 mm (p<0.0001), DRR 56% vs 25% (p=0.0006), complete resolution 32% vs 14% (p=0.0152), muscle spasms 36% vs 6%, hearing impairment 13% vs 3% — all match. Teprotumumab review (PMC7334856) live: 'On 21st January 2020, the FDA approved Tepezza (teprotumumab-trbw)...' / 'first drug approval for the treatment of GO', the 'fully human monoclonal IgG1 antibody that binds with high selectivity and affinity to insulin-like growth factor 1 receptor (IGF-1R)' quote, OPTIC 83% vs 10% (p<0.001), and dosing '10 mg/kg thereafter 20 mg/kg every 3 weeks for 21 weeks' — all verbatim.

Rule 9 (clinical-statistic provenance) satisfied. Every clinical statistic is cited to the PRIMARY paper that contains it: THRIVE figures to PMC12545473, THRIVE-2 figures to academic.oup.com (Journal of the Endocrine Society), teprotumumab/OPTIC figures to PMC7334856, regulatory/quote layer to the BioSpace release. CRITICAL Rule 5i check passed: the article does NOT fabricate an 'eight infusions' token for veligrotug; veligrotug is consistently described as a 'five-infusion' course (per the BioSpace release), and teprotumumab is described with its own sourced 'every 3 weeks for 21 weeks' wording (per the PMC review) rather than an invented infusion count. No fabricated specifics, no hallucinated quotes, no misattribution detected across any source.

APPROVE_WITH_CORRECTIONS. The article is substantively clean — every clinical statistic and direct quote traces verbatim to its correct primary source, Rule 9 and Rule 5i are satisfied, and the topic is original. The only issue is that 3 of 4 source snapshots could not be auto-archived (PMC reCAPTCHA, OUP 403); all were editor-verified live. A clarification record documents this provenance limitation transparently.