Remibrutinib is a Novartis Ag program in adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. Its next catalyst is a Readout in Jun 2027. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Remibrutinib is marketed as Rhapsido (remibrutinib); the events below include those tracked under the brand name. FDA approval tracked on pdufa.bio: adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines (approved Oct 6, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Novartis Ag (NVS). Approval record: Efficacy supplement to NDA 218436 (Rhapsido, first approved September 30, 2025 for chronic spontaneous urticaria). Approval based on the symptomatic dermographism cohort of the Phase III RemIND trial: complete response at Week 12 in 29.3% of patients on Rhapsido versus 14.0% on placebo (p=0.0229), per Novartis. Market-cap tier at the time we tracked it: Large. We track 3 catalyst events for this program: 1 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
The next tracked catalyst for Remibrutinib is a Readout in Jun 2027.
On Oct 6, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Remibrutinib is FDA-approved for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines (approved Oct 6, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Novartis Ag (NVS).
Yes. The FDA approved an application for Remibrutinib on Oct 6, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.