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Mind Medicine (MindMed) (MNMD) FDA Events

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FDA Events for Mind Medicine (MindMed) (MNMD)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Mind Medicine (MindMed) (MNMD). Over the past two years, Mind Medicine (MindMed) has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MM120. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

MM120 - FDA Regulatory Timeline and Events

MM120 is a drug developed by Mind Medicine (MindMed) for the following indication: For Generalized Anxiety Disorder. 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.

Mind Medicine (MindMed) FDA Events - Frequently Asked Questions

As of now, Mind Medicine (MindMed) (MNMD) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Mind Medicine (MindMed) (MNMD) has reported FDA regulatory activity for MM120.

The most recent FDA-related event for Mind Medicine (MindMed) occurred on April 15, 2025, involving MM120. The update was categorized as "Dose Update," with the company reporting: "Mind Medicine announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD."

Currently, Mind Medicine (MindMed) has one therapy (MM120) targeting the following condition: For Generalized Anxiety Disorder.

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:MNMD) was last updated on 7/9/2025 by MarketBeat.com Staff
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