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Jul 17, 2026Weekly roundup2 fact check notes

Novartis posts pelacarsen Phase 3 apheresis results, updates three drug labels

Novartis reported positive Phase 3 data for pelacarsen in Lp(a) patients on apheresis, filed label updates for Tegretol and Gleevec, and logged new trials for remibrutinib, ribociclib and Pluvicto.

Novartis had an active week spanning a completed Phase 3 readout, three FDA label updates, and new interventional and observational study listings.

  • Pelacarsen (TQJ230), a Phase 3 treatment for hyperlipoproteinemia(a) in patients on weekly lipoprotein apheresis in Germany, finished with results posted for study NCT05305664. Patients on pelacarsen had an apheresis session rate of 0.16 per week versus 0.93 on placebo, with the difference reaching p<0.0001 in a fractional regression model.1 The trial tested whether pelacarsen 80 mg given every four weeks reduces lipoprotein apheresis rates compared with placebo in patients with hyperlipoproteinemia(a) and established cardiovascular disease.1
  • The FDA approved a labeling supplement for Tegretol-XR extended-release tablets (carbamazepine, NDA020234, supplement 57), with the submission status dated 2026-07-15 and the label posted 2026-07-29.
  • A parallel labeling supplement was approved for Tegretol oral suspension (carbamazepine, NDA018927, supplement 63), also with a submission status date of 2026-07-15.
  • A third labeling supplement was approved for Tegretol tablets (carbamazepine, NDA016608, supplement 124), sharing the same 2026-07-15 submission status date and appearing in the same approval letter package as the XR and suspension supplements.
  • The FDA approved a labeling supplement for Gleevec (imatinib mesylate) tablets, NDA021588 supplement 67, with a submission status date of 2026-07-13.
  • Remibrutinib, a BTK inhibitor, entered a Phase 3 trial for severe chronic pruritus of unknown origin (NCT07700056) that is now recruiting. The primary outcome measures the proportion of participants achieving at least a 4-point reduction from baseline in the Worst Itch Numerical Rating Scale, which ranges from 0 to 10.2 Planned enrollment is 180 participants.2
  • Novartis registered CATTALYST (NCT07710716), a real-world observational study of adjuvant ribociclib in HR+/HER2- early breast cancer that is active but not recruiting. The study will assess clinical adoption, treatment patterns, and safety of adjuvant ribociclib using secondary real-world data across multiple countries.3 Planned enrollment is 3000 participants.3
  • Novartis also registered PRISM (NCT07697989), an observational study of real-world outcomes with [177Lu]Lu-PSMA-617 (Pluvicto) in metastatic castration-resistant prostate cancer; the study is listed as not yet recruiting. It will evaluate treatment effectiveness of Pluvicto in pre- and post-taxane settings using real-world data from the United States and Germany.4 Planned enrollment is 1085 participants.4

Fact check notes

  • ImpreciseNovartis posts pelacarsen Phase 3 apheresis results, updates three drug labelsThe headline says Novartis 'updates three drug labels,' but the sources show four separate labeling supplements approved (Tegretol-XR NDA020234, Tegretol oral suspension NDA018927, Tegretol tablets NDA016608, and Gleevec NDA021588). The pelacarsen results claim itself is accurate, but the label count is off.
  • Checker's noteHeadline states Novartis 'updates three drug labels,' but the sources document four approved labeling supplements (Tegretol-XR NDA020234 suppl 57, Tegretol suspension NDA018927 suppl 63, Tegretol tablets NDA016608 suppl 124, and Gleevec NDA021588 suppl 67).

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.