Roivant Phase III Batoclimab Trial Is Positive, But No Filing Planned

The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.

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Key Takeaways
  • Roivant’s batoclimab showed positive efficacy in a Phase III myasthenia gravis trial, but the company is focused on next-generation FcRn inhibitor IMVT-1402.
  • The two drugs are being developed under Roivant’s Immunovant subsidiary, which is focused on bringing a best-in-class FcRn inhibitor to market.
  • The positive data suggest IMVT-1402 could beat rivals on efficacy, but potential registration-enabling studies are just getting under way.

Roivant subsidiary Immunovant announced positive Phase III data for its neonatal fragment crystallizable receptor (FcRn) inhibitor batoclimab in myasthenia gravis (MG), but a key piece of the update is how the data

Despite positive data, Roivant said it does not expect to file batoclimab in either MG or another indication, chronic inflammatory demyelinating polyneuropathy (CIDP), as it continues to prioritize IMVT-1402

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