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Cabaletta Bio (CABA) FDA Events

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FDA Events for Cabaletta Bio (CABA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cabaletta Bio (CABA). Over the past two years, Cabaletta Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CABA-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CABA-201 - FDA Regulatory Timeline and Events

CABA-201 is a drug developed by Cabaletta Bio for the following indication: For Treatment of Generalized 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.

Cabaletta Bio FDA Events - Frequently Asked Questions

As of now, Cabaletta Bio (CABA) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Cabaletta Bio (CABA) has reported FDA regulatory activity for CABA-201.

The most recent FDA-related event for Cabaletta Bio occurred on June 11, 2025, involving CABA-201. The update was categorized as "New Data," with the company reporting: "Cabaletta Bio, Inc. announced new clinical and translational data from the ongoing RESET-Myositis™, RESET-SLE™ and RESET-SSc™ trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201)."

Currently, Cabaletta Bio has one therapy (CABA-201) targeting the following condition: For Treatment of Generalized Myasthenia Gravis.

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:CABA) was last updated on 7/10/2025 by MarketBeat.com Staff
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