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Ovid Therapeutics (OVID) FDA Events

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FDA Events for Ovid Therapeutics (OVID)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ovid Therapeutics (OVID). Over the past two years, Ovid Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OV329 and OV888/GV101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ovid Therapeutics' Drugs in FDA Review

OV329 - FDA Regulatory Timeline and Events

OV329 is a drug developed by Ovid Therapeutics for the following indication: In Treatment-Resistant Seizures. 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.

OV888/GV101 - FDA Regulatory Timeline and Events

OV888/GV101 is a drug developed by Ovid Therapeutics for the following indication: For Cerebral Cavernous Malformations. 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.

Ovid 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, Ovid Therapeutics (OVID) has reported FDA regulatory activity for the following drugs: OV329 and OV888/GV101.

The most recent FDA-related event for Ovid Therapeutics occurred on September 26, 2024, involving OV329. The update was categorized as "presented results," with the company reporting: "Ovid Therapeutics Inc. announced that it presented the results of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with vigabatrin (VGB) the only FDA-approved GABA-aminotransferase (GABA-AT) inhibitor."

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

  • In Treatment-Resistant Seizures - OV329
  • For Cerebral Cavernous Malformations - OV888/GV101

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