Monday, 29 June 2026

Vol. 1 · No. 27 Monday, 29 June 2026 “Evidence is the medicine that keeps regulators honest.”

Trials Today

Phase 3 PROPEL 3 — Infigratinib in Achondroplasia — Primary endpoint met (+1.74 cm/yr AHV vs placebo; p<0.0001); NDA filing planned Q3 2026. NEJM publication June 28, 2026.
Phase 3 HOPE-3 — Deramiocel (CAP-1002) in Duchenne MD — Dual skeletal (PUL 2.0 +4.55%; p=0.029) and cardiac (LVEF; p=0.041) endpoints met. PDUFA date August 22, 2026.
Phase 2/3 WONDERS-2 — Lepetegravir + Lenacapavir Pacfosacil in HIV-1 — TERMINATED March 2026 after FDA clinical hold over CD4+ T-cell drops; hold not lifted. Once-weekly oral HIV regimen abandoned.

At the Agencies

EMA: Tavneos (avacopan) — CHMP recommends revocation — ADVOCATE trial data found incorrect and misleading due to GCP breach; opinion forwarded to European Commission for binding decision. Drug remains approved in US pending FDA review.
FDA: Trodelvy (sacituzumab govitecan-hziy) — Full approval, first-line mTNBC — Two indications approved June 24-25, 2026: monotherapy (ASCENT-03; PFS HR 0.62) and combination with pembrolizumab for PD-L1+ disease (ASCENT-04; PFS HR 0.65). Both supported by NEJM publications.
EMA: DAYBU (trofinetide) — CHMP positive opinion for Rett syndrome — Reversed February 2026 negative opinion after re-examination; first EU pharmacotherapy for Rett syndrome if EC confirms. Pivotal LAVENDER trial published in Nature Medicine.
FDA: Lumvoa (veligrotug-vvze) — Approved for thyroid eye disease, active and chronic — First IGF-1R inhibitor cleared for both active (THRIVE) and chronic (THRIVE-2) TED. Broader label than teprotumumab. Approved June 26, 2026.
FDA: NASP (nanoencapsulated sirolimus + pegadricase) — Complete Response Letter for uncontrolled gout — CRL issued June 26, 2026 citing manufacturing deficiencies only; FDA stated no concerns about clinical efficacy or safety. Sobi to request remediation meeting.

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 →

On the Wire

Osimertinib With or Without Bevacizumab as Initial... 26 days ago
FDA Issues Draft Guidance to Help Accelerate Cell and... 26 days ago
Selinexor Plus Ruxolitinib in JAK Inhibitor-Naïve... 26 days ago
DKK1 and CKAP4 expression is associated with cervical... 28 days ago
IMU Biosciences nabs $53M funding round to ‘decode’ the... 25 days ago
Flex Appeal: Evaluating the Efficacy of Anesthetic... 26 days ago
NHS consultants are "quiet quitting," senior doctors... 26 days ago

Full wire (160) →

← The archive

Monday, 29 June 2026 edition — The Vital Record