Thursday, 25 June 2026 edition — The Vital Record
Vol. 1 · No. 23
Thursday, 25 June 2026
“Evidence is the beginning of argument, not the end of it.”
In this edition
Vol. 1, No. 23 leads with the European Commission's approval of tolebrutinib (Cenrifki) for non-relapsing secondary progressive MS — the first disability-targeting drug in its class, and a direct rebuke of the FDA's December 2025 Complete Response Letter over hepatotoxicity — setting up the most consequential transatlantic regulatory split in years. Supporting stories span a practice-changing anticoagulation head-to-head RCT, CRISPR gene therapy holding 96% of sickle cell patients crisis-free at two years, GSK's $10.6 billion tender for Nuvalent, a Class I Impella controller recall linked to three deaths, and mounting congressional pressure to kill CMS's AI prior-authorization pilot.
Trials Today
Phase 4
COBRRA (NCT03266783)
— Apixaban vs. rivaroxaban head-to-head in acute VTE; N=2,760; primary endpoint: clinically relevant bleeding at 3 months.
Phase 3
STOMP (NCT05534984)
— Tecovirimat vs. placebo in clade II mpox; N=719; terminated for futility at interim analysis; results published NEJM Feb 2026.
Phase 1/2
RUBY (NCT04853576)
— Reni-cel (CRISPR-Cas12a, reni-cel) autologous HSCT in severe SCD; N=28; 96% vaso-occlusive event-free at up to 24 months.
Phase 3
HERCULES (NCT04411641)
— Tolebrutinib vs. placebo in non-relapsing SPMS; N=1,131; 31% reduction in 6-month confirmed disability progression; basis for EU approval of Cenrifki.
Phase 3
BREAKWATER (NCT04607421)
— Encorafenib + cetuximab + mFOLFOX6 vs. SOC as first-line therapy in BRAF V600E mCRC; median OS 30.3 vs. 15.1 months; basis for EC approval.
Who's Who
Robert Michael
Chief Executive Officer, AbbVie
Announced AbbVie's $10.9 billion all-cash acquisition of Apogee Therapeutics on June 22, 2026, adding zumilokibart (APG777), an IL-13–targeting monoclonal antibody in late-stage development for atopic dermatitis and asthma, to AbbVie's immunology pipeline as it braces for Humira biosimilar headwinds.
The story →
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