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Immunovant (IMVT) FDA Events

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FDA Events for Immunovant (IMVT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunovant (IMVT). Over the past two years, Immunovant has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Batoclimab and IMVT-1402. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Immunovant's Drugs in FDA Review

Batoclimab - FDA Regulatory Timeline and Events

Batoclimab is a drug developed by Immunovant for the following indication: Myasthenia Gravis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

IMVT-1402 - FDA Regulatory Timeline and Events

IMVT-1402 is a drug developed by Immunovant for the following indication: FcRn inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Immunovant FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Immunovant (IMVT) has reported FDA regulatory activity for the following drugs: Batoclimab and IMVT-1402.

The most recent FDA-related event for Immunovant occurred on April 21, 2025, involving IMVT-1402. The update was categorized as "Provided Update," with the company reporting: "Immunovant, Inc announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE."

Current therapies from Immunovant in review with the FDA target conditions such as:

  • Myasthenia Gravis - Batoclimab
  • FcRn inhibitor - IMVT-1402

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:IMVT) was last updated on 7/10/2025 by MarketBeat.com Staff
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