Sunday, 28 June 2026 edition — The Vital Record
Vol. 1 · No. 26
Sunday, 28 June 2026
“Evidence does not negotiate; it only accumulates.”
In this edition
This edition is anchored by a rare dual-regulator integrity crisis — the FDA and EMA moving simultaneously to pull avacopan from market over clinical trial data manipulation and fatal liver injury — alongside the definitive Phase 3 verdict that oral semaglutide does not slow Alzheimer's disease, a landmark negative that closes a chapter on the GLP-1/neurodegeneration hypothesis. Across beats: the Bundibugyo Ebola PHEIC passes 1,155 confirmed cases with imported cases now in Europe; FDA clears the first multicondition AI structural-heart screen from a routine ECG; a Phase 2 trial of teclistamab-based induction achieves 100% response in newly diagnosed myeloma; GSK launches a $10.6B tender for Nuvalent's two PDUFA-stage lung cancer drugs; four toddlers recover hearing after re-dosing AAV gene therapy despite high neutralizing antibody titers; and the FDA authorizes the first patient-facing LLM for insulin management.
Trials Today
Phase 3
EVOKE / EVOKE+ (NCT04777409)
— Oral semaglutide vs. placebo in 3,808 amyloid-confirmed early Alzheimer's patients; both arms negative at week 104 on CDR-SB; trials discontinued.
Phase 3
NRG-LU005 (NCT03811002)
— Chemoradiation ± atezolizumab in limited-stage SCLC; OS not improved (HR 1.03); twice-daily RT associated with survival benefit independent of immunotherapy arm.
Phase 3
KEYVIBE-008 (NCT05224141)
— Vibostolimab/pembrolizumab vs. atezolizumab + chemo in extensive-stage SCLC; arm discontinued at interim analysis for futility and higher immune-related adverse events.
Phase 2
MajesTEC-5 / GMMG-HD10 (NCT05695508)
— Teclistamab + daratumumab + lenalidomide ± bortezomib induction in transplant-eligible newly diagnosed myeloma; ORR 100%, MRD-negative CR 91.8% at pre-maintenance timepoint.
Phase 1 (long-term extension)
NI006-101 OLE2 (NCT04360434)
— Cliramitug (anti-misfolded TTR antibody) in ATTR cardiomyopathy; 29-month follow-up showing continued cardiac amyloid clearance; longest published dataset for this class.
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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