Wednesday, 1 July 2026 edition — The Vital Record
Vol. 1 · No. 29
Wednesday, 1 July 2026
“Evidence first, then headlines.”
In this edition
Vol. 1, No. 29 is anchored by two landmark FDA approvals — Trodelvy's expansion into first-line triple-negative breast cancer and the first oral carbapenem for serious UTIs — alongside a pivotal Phase 3 gene therapy win in prostate cancer and a safety alert linking a software flaw in an ICU heart-pump controller to three deaths. This edition spans six beats, led by regulatory news and clinical trial data that set new treatment standards in oncology, infectious disease, and digital health.
Trials Today
Phase 3
NCT01436968 — CAN-2409 Prostate (Phase 3, completed)
— Lancet Oncology publication confirmed 30% reduction in disease-free survival events; BLA filing expected Q4 2026.
Phase 3
NCT07660094 — AURORA (CAN-2409 in NSCLC, Phase 3, recruiting)
— Opened June 15, 2026; 500 patients; ICI-refractory Stage IV non-squamous NSCLC; primary completion October 2031.
Phase 3
NCT06828861 — HERO Trial (ARD-101 in PWS, Phase 3, terminated)
— FDA full clinical hold imposed May 14, 2026 after cardiac signals; both Phase 3 arms terminated at partial enrollment.
Phase 3
NCT05746559 — ARTEMIS (ravulizumab in CKD/cardiac surgery, Phase 3, completed)
— 544 patients; study completed May 7, 2026; results not yet posted publicly; watch for data release.
Phase 2b
NCT04365868 — NAVIGATE (belapectin in MASH cirrhosis, Phase 2b, terminated)
— Per-protocol endpoint met (p=0.04); FDA Type C meeting June 23, 2026 aligned on Phase 3 design; protocol submission planned Q3 2026.
At the Agencies
FDA APPROVAL — Sacituzumab govitecan-hziy (Trodelvy) in first-line TNBC, June 24, 2026 — Two indications: monotherapy (ASCENT-03) and in combination with pembrolizumab (ASCENT-04/KEYNOTE-D19) for PD-L1+ tumors. FDA APPROVAL — Olezarsen (Tryngolza) for severe hypertriglyceridemia, June 24, 2026 — First therapy shown to reduce acute pancreatitis risk in this population; monthly subcutaneous injection. FDA APPROVAL — Tebipenem pivoxil (Utebzi) for cUTI, June 17, 2026 — First oral carbapenem approved in the US; non-inferiority to IV imipenem-cilastatin in the PIVOT-PO Phase 3. EMA CHMP POSITIVE OPINION — Pirtobrutinib (Jaypirca) for CLL across all lines, June 26, 2026 — Covers treatment-naive and post-covalent BTK inhibitor patients; EC decision expected within 2 months. FDA CLASS I RECALL — Abiomed Automated Impella Controller (AIC), recall ID 218584 — Software flaw causes ~35-second pump stoppage; 3 deaths reported as of June 13, 2026; correction via updated use instructions. FDA CRL — Lantheus LNTH-2501 (Ga-68 edotreotide) for NET imaging, June 26, 2026 — Manufacturing deficiencies at third-party facility; no safety or efficacy concerns cited; resubmission timeline not announced.
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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