Unusual Volume

Novartis Jumps 6% After MS Pill Remibrutinib Succeeds in Two Phase 3 Trials, Even as CAR-T Deaths Trigger Pause

Novartis AG $NVS

$161.21+6.02%as of publication

5D Change
+3.39%
Volume
48
vs Average
16.0×
Market Cap
$289.02B

Novartis shares surged roughly 6% to approximately $161.10 on Tuesday, on track for their best single-day gain since 2023, after the company reported that remibrutinib, an oral BTK inhibitor, met its primary endpoints in two late-stage trials, called REMODEL, in patients with relapsing multiple sclerosis. The drug delivered significantly fewer relapses and fewer brain lesions compared with the rival treatment teriflunomide, without raising liver safety concerns, and Novartis estimated peak annual sales for remibrutinib could exceed $3 billion.

Remibrutinib is a highly selective, oral Bruton's tyrosine kinase inhibitor that works by blocking B-cell and innate immune cell activation to reduce neuroinflammation. It already holds FDA approval, granted in September 2025, and EMA approval, granted in April 2026, under the brand name Rhapsido for chronic spontaneous urticaria. The positive Phase 3 MS readout substantially broadens its potential market. Citi analysts cautioned that the critical comparison will come at a more detailed data presentation scheduled for October, when remibrutinib's profile will be weighed against Roche's rival BTK inhibitor fenebrutinib.

On the same day, Novartis confirmed it had temporarily paused screening, randomization, and treatment across eight clinical trials of rapcabtagene autoleucel, or rap-cel, an experimental CAR-T cell therapy targeting autoimmune and neurological disorders. The pause followed three patient deaths attributed to severe immune response, discovered in late August. The two programs are separate, and the market ultimately treated the session as a net positive, with investors focusing on the blockbuster potential of remibrutinib over the rap-cel setback. Elevated options activity in Novartis stock signaled that traders expected continued volatility ahead.

© AI-generated summary is provided by Market Flux

Sources

  1. wsj.comNovartis Pauses Autoimmune Cell Therapy Studies After Deaths
  2. reuters.comNovartis pauses autoimmune cell therapy studies after deaths, WSJ reports
  3. FirstSquawkNovartis says oral BTK inhibitor remibrutinib significantly reduces relapse rates in Phase III RMS trials
  4. Seeking AlphaNovartis halts autoimmune CAR-T trials following three patient deaths: WSJ
  5. ReutersNovartis' oral multiple sclerosis drug meets main goal in late stage studies
  6. BloombergNovartis Pauses Autoimmune Drug Trials After Three Patients Die
  7. BusinessNovartis’ experimental multiple sclerosis pill succeeded in two late-stage trials, boosting its chances of becoming a new oral treatment for the chronic neurological disease
  8. InvestingNovartis shares rise after multiple sclerosis drug hits late-stage trial goals
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