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Sep 3, 2026Weekly roundup

CIBINQO label updated by FDA; Pfizer's rimegepant China trial and pipeline items still active

Pfizer secured a label supplement approval for CIBINQO (abrocitinib) this week, alongside its previously reported rimegepant results and five other registered or recruiting studies.

Pfizer's week was led by a new FDA label action, with the rest of the pipeline holding steady from prior reporting.

  • The FDA approved a labeling supplement (SUPPL 3) for CIBINQO (abrocitinib), available in 200MG, 50MG, and 100MG oral tablets, with the submission status marked "AP" and a status date of 2026-09-021, with the updated label and medication guide posted in September 2026.
  • Results were posted for a completed Phase 3 trial of rimegepant for migraine prevention in Chinese participants. The study was randomized, phase 3, and enrolled 787 participants (actual)2. The trial's primary completion date was 2025-08-25, and results were first posted 2026-09-03.
  • A Phase 3 trial of a multivalent pneumococcal conjugate vaccine (PG4) is recruiting. Participants will be assigned by chance in a 2:2:2:1 ratio to receive PG4 lot 1, PG4 lot 2, PG4 Lot 3, or 20vPnC3. Enrollment is estimated at 4670 participants3.
  • A Phase 3 BNT162b2 COVID-19 vaccine study sponsored by BioNTech, with Pfizer as collaborator, is not yet recruiting. The trial will evaluate the safety, tolerability, and immunogenicity of BNT162b2 RNA-based, variant-adapted vaccine candidates against SARS-CoV-2 in children and adults4. Enrollment is estimated at 700 participants4.
  • Two Phase 3 obesity trials of once-weekly and once-monthly berobenatide in Japan (VESPER-JW and VESPER-JM) remain not yet recruiting. The once-weekly study expects about 180 adults to take part5, while the once-monthly version expects about 197 adults6. Both list percent change in body weight from baseline at Week 72 as the primary outcome.
  • An observational study on growth hormone deficiency in traumatic brain injury, sponsored by the University of Calgary with Pfizer as collaborator, is recruiting. The study aims to characterize the impact of growth hormone deficiency on quality of life, symptom burden, and sleep in adults with traumatic brain injury, and to evaluate whether these outcomes improve with growth hormone replacement therapy7. Enrollment is estimated at 200 participants7.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.