Life Sciences Daily Summary
Life Sciences Daily Summary: What Happened on October 8, 2026
Biohub raises $1.8 billion for virtual biology
Argenx stops a Sjögren’s trial, the FDA approves a new Tukysa regimen, and drugmakers face tariffs and a PhRMA lawsuit.
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Today in brief
Biohub raised $1.8 billion for its virtual biology initiative.1 Argenx halted its Phase 3 Sjögren’s study after an interim analysis found it unlikely to meet its primary endpoint.23 Pfizer’s Tukysa won FDA approval with trastuzumab and pertuzumab as maintenance treatment for certain adults with advanced HER2-positive breast cancer.4
The World Health Organization issued its first global childhood obesity guidance, recommending lifestyle support before medicines for children under 10.5 PhRMA challenged the administration’s GLOBE Medicare pricing model in court as pharmaceutical import tariffs took effect and companies sought clearer exemption guidance.678
Argenx ends Phase 3 Sjögren’s trial after futility review
An independent monitoring committee recommended stopping Argenx’s UNITY trial of efgartigimod for Sjögren’s disease after an interim review found it unlikely to meet its primary endpoint.23 Argenx reported no new safety signals.23
The company had expected results in the second half of 2027.2 Argenx plans to review the full dataset after the trial closes and the database is locked.23
Separately, Argenx said its investigational drug FB102 met the primary endpoint in a Phase 2 celiac disease study.2 The company plans to advance FB102 to Phase 3 and continue testing it in vitiligo and alopecia areata.2
FDA clears Tukysa maintenance regimen for HER2-positive breast cancer
The FDA approved Pfizer’s Tukysa with pertuzumab and trastuzumab for adults with unresectable, locally advanced or metastatic HER2-positive breast cancer whose disease has not progressed after induction treatment.4 The regimen adds oral tucatinib to maintenance therapy after initial, taxane-based treatment.4
In the Phase 3 trial, median progression-free survival was 24.9 months with Tukysa and 16.3 months with placebo, a difference of 8.6 months.4 Tukysa reduced the risk of progression or death by 35.9% compared with the control regimen.4
Serious liver toxicity affected 3.9% of patients, including one fatal drug-induced liver injury.4 The prescribing information requires liver-function testing and carries a boxed warning for severe liver toxicity.9 The trial has not yet been shown to have met its overall-survival endpoint.9
WHO puts lifestyle support first in new childhood obesity guidance
The World Health Organization recommends programs addressing diet, physical activity, and behavior as the foundation of obesity care for children and adolescents.5 For children 9 and younger, it advises against weight-loss medicines, devices, and bariatric surgery.5
For adolescents, approved medicines may be considered if a supervised, multicomponent lifestyle program has not achieved the desired result.5 Surgery remains an option for adolescents with severe obesity, and supervised digital health interventions may also help.5
Obesity prevalence among people ages 5 to 19 has quadrupled since 1990, reaching 170 million affected in 2024.5
PhRMA challenges Medicare drug-pricing model in court
PhRMA sued the Trump administration over GLOBE, a Medicare Part B pilot that uses international prices to set an alternative rebate formula for some drugs and biologics.610 PhRMA argues that the Centers for Medicare & Medicaid Services exceeded its authority by imposing mandatory rebates through a demonstration model.10
The model is scheduled to run from January 1, 2027, through March 31, 2032, and covers beneficiaries in randomly selected areas.10 The administration exempted most companies in exchange for agreements to accept voluntary deals linking Medicaid prices to peer-country rates.7
A 100% tariff on imported patented drugs and their active ingredients began applying at the end of September.8 Some biopharma companies and their industry group said guidance on qualifying for exemptions remained unclear.8 Companies with most-favored-nation agreements have tariff payments deferred until early 2029, while smaller biotechnology firms remain exposed.8
