Novartis reports year-long Rhapsido results in three inducible urticaria types; filing plans unstated
The company says its remibrutinib twice-daily regimen worked from the early weeks to Week 52 in the RemIND Phase III study, but no numbers, safety data or regulatory plans accompanied the claim.
Novartis said on 12 November 2026 that Rhapsido (remibrutinib) 25 mg taken twice daily kept patients' symptoms in check for a full year in RemIND, a Phase III trial in chronic inducible urticaria (CIndU). The company says the benefit emerged soon after treatment began and was still present at Week 52.
The reported effect covers three forms of the disease: symptomatic dermographism, cold urticaria and cholinergic urticaria. Novartis has not, in the information available to us, put a figure on any endpoint, so the size of the benefit cannot yet be judged.
Nor is there any commercial read-across yet. The material did not mention regulatory submissions in CIndU, label-expansion timing, or revenue expectations for the new indications, so any assessment of how much this adds to Rhapsido's potential would be guesswork.
Novartis plans to present the full data as a late-breaking abstract at the ACAAI 2026 Annual Scientific Meeting. Abstracts of this kind generally surface close to the time of presentation, so details on efficacy and, importantly, 52-week safety may only appear at the meeting.
Why it matters
- Positive top-line framing across three CIndU subtypes is a pipeline signal, but without endpoint data or filing timelines it cannot yet be valued.
- Long-term safety at 52 weeks is the missing piece; tolerability conclusions should wait for the ACAAI presentation.
- Market-access and strategy teams can begin tracking the programme, but a proper value case depends on the detailed results.
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.