Novartis (NVS) shares climbed on Tuesday after the Swiss drugmaker reported positive Phase 3 results for its experimental multiple sclerosis treatment, remibrutinib. The stock was up 5.86% at $160.97 at the time of publication, according to market data.
The Multiple Sclerosis Drug Race Just Got Hotter After Novartis’ Phase 3 Win
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Novartis stock spikes 5% on positive Phase 3 REMODEL trial results for relapsing MS drug remibrutinib with no liver safety signals.
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Remibrutinib Meets Primary Goal
Remibrutinib significantly reduced annualized relapse rates compared with teriflunomide in the REMODEL-1 and REMODEL-2 trials. The oral treatment also reduced inflammatory brain lesions.
Both trials enrolled adults with relapsing multiple sclerosis. The results establish remibrutinib as the first BTK inhibitor to significantly reduce annualized relapse rates across two Phase 3 studies, Novartis said.
A combined analysis also showed a positive trend in three-month confirmed disability progression. In addition, remibrutinib achieved nominal statistical significance in six-month confirmed disability progression.
Novartis Reports No Liver Safety Signal
Novartis said remibrutinib was well tolerated. Its safety profile matched findings from the drug's wider development program, which includes more than 4,500 clinical trial participants.
The company also said the treatment continued to show no liver safety signal.
William Blair Flags Competition
William Blair said Tuesday that the results highlight growing competition in the multiple sclerosis market.
Analyst Myles Minter called the efficacy data positive. However, he said the full REMODEL results will be important for comparing remibrutinib with fenebrutinib. Roche Holding AG (RHHBY) and Genentech plan to seek global approval for fenebrutinib.
Minter also highlighted CD40 ligand drugs as an emerging approach. Sanofi SA's (SNY) frexalimab previously delivered positive Phase 2 results. Still, he warned that both drug classes could increase infection risks.
Novartis Price Action
NVS Price Action: Novartis shares were up 5.86% at $160.97 at the time of publication on Tuesday, according to market data.
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