Rhapsido (remibrutinib) was approved by the FDA on October 6, 2026 for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.
Novartis says Rhapsido is the first treatment approved for symptomatic dermographism, the most common form of chronic inducible urticaria. Rhapsido was first approved on September 30, 2025 for chronic spontaneous urticaria in adults not controlled by H1 antihistamines.
The FDA's Drugs@FDA data record this efficacy supplement (NDA 218436, supplement 1) as approved on October 6, 2026. Novartis announced the approval on October 7, 2026 (Novartis release). Per Novartis, the approval is based on the symptomatic dermographism cohort of the Phase III RemIND trial in patients who remained symptomatic on second-generation H1 antihistamines: at Week 12, 29.3% of patients on Rhapsido achieved a complete response from hives versus 14.0% on placebo (p=0.0229), with responses seen as early as Week 2. Novartis lists the most common adverse events (3% or more) as nasopharyngitis, bleeding, headache, nausea and abdominal pain. pdufa.bio holds no goal date for this supplement, so no early or late margin is computed. The FDA's approval letter is listed in Drugs@FDA data but had not been posted when this page was published.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Drugs@FDA, NDA 218436 (Rhapsido), supplement 1 approved October 6, 2026
FDA record of the action: the FDA approved on October 6, 2026, per NDA 218436 S-001 (openFDA AP 2026-10-06; letter listed, not yet posted) (Drugs@FDA). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Rhapsido (remibrutinib) on October 6, 2026, per the FDA's own record. The primary source is linked on this page.
Rhapsido (remibrutinib) is a Novartis (NVS) program. The FDA decision came on October 6, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), NVS moved -7.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
The FDA's Drugs@FDA data record the approval of the Rhapsido (remibrutinib) efficacy supplement, NDA 218436 supplement 1, on October 6, 2026. Novartis announced it on October 7, 2026, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.
The symptomatic dermographism cohort of the Phase III RemIND trial. Per Novartis, 29.3% of patients on Rhapsido achieved a complete response from hives at Week 12 versus 14.0% on placebo (p=0.0229).
The FDA first approved Rhapsido (remibrutinib) on September 30, 2025, for adults with chronic spontaneous urticaria inadequately controlled by H1 antihistamines (NDA 218436).