Friday, 26 June 2026 edition — The Vital Record
Vol. 1 · No. 24
Friday, 26 June 2026
“Evidence first, then the story.”
In this edition
Today's edition leads with FDA's dual approval of sacituzumab govitecan in first-line triple-negative breast cancer — the first ADC to reach the frontline metastatic setting — alongside a rare FDA proposal to yank avacopan over alleged data fraud and fatal liver injuries. Rounding out the issue: paradigm-shifting primary-prevention data for PCSK9 inhibition, survodutide's emergence as a new obesity drug class contender, the closure of the MV Hondius hantavirus response, novel sexual transmission of a livestock bacterium in Europe, waning durability data for nirsevimab, and an FDA early alert on Impella introducer kits linked to three deaths.
Trials Today
Phase 3
VESALIUS-CV (NCT03872401)
— Evolocumab vs placebo in primary-prevention atherosclerosis/high-risk diabetes; n=12,257; primary endpoint met (HR 0.75, p<0.001); published NEJM Jan 2026.
Phase 3
SYNCHRONIZE-1 (NCT06066515)
— Survodutide (dual GLP-1/glucagon agonist) vs placebo in obesity without T2DM; 76 weeks; 16.6% mean weight loss at highest dose; published NEJM June 2026.
Phase 3
ASCENT-04/KEYNOTE-D19 (NCT05382286)
— Sacituzumab govitecan + pembrolizumab vs chemotherapy + pembrolizumab in first-line PD-L1+ metastatic TNBC; supports FDA approval granted June 24, 2026.
Phase 3
ASCENT-03 (NCT05382299)
— Sacituzumab govitecan monotherapy vs chemotherapy in first-line TNBC ineligible for PD-1/PD-L1 inhibitors; supports FDA approval granted June 24, 2026.
Phase 3
NRG-GY026 (NCT05256225)
— HER2-targeted therapy in HER2+ endometrial serous carcinoma/carcinosarcoma; status: SUSPENDED as of June 24–26, 2026; reason not yet disclosed.
Phase 3
ARGSARC (NCT05712694)
— Pegargiminase + gemcitabine/docetaxel vs placebo in second/third-line leiomyosarcoma; n=218; status: TERMINATED (primary completion May 2026); reason not yet public.
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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