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Sage Therapeutics (SAGE) FDA Events

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FDA Events for Sage Therapeutics (SAGE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Sage Therapeutics (SAGE). Over the past two years, Sage Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SAGE-324 and SAGE-718. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Sage Therapeutics' Drugs in FDA Review

SAGE-324 (BIIB124) - FDA Regulatory Timeline and Events

SAGE-324 (BIIB124) is a drug developed by Sage Therapeutics for the following indication: For the Treatment of Essential Tremor. 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.

SAGE-718 - FDA Regulatory Timeline and Events

SAGE-718 is a drug developed by Sage Therapeutics for the following indication: In the Treatment of Mild Cognitive Impairment in Parkinson's Disease. 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.

Sage Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Sage Therapeutics (SAGE) has reported FDA regulatory activity for the following drugs: SAGE-718 and SAGE-324 (BIIB124).

The most recent FDA-related event for Sage Therapeutics occurred on November 20, 2024, involving SAGE-718. The update was categorized as "Top-line results," with the company reporting: "Sage Therapeutics, Inc announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington's Disease (HD)."

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

  • In the Treatment of Mild Cognitive Impairment in Parkinson's Disease - SAGE-718
  • For the Treatment of Essential Tremor - SAGE-324 (BIIB124)

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