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Cognition Therapeutics (CGTX) FDA Events

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FDA Events for Cognition Therapeutics (CGTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cognition Therapeutics (CGTX). Over the past two years, Cognition Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CT1812 and CT1812. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cognition Therapeutics' Drugs in FDA Review

CT1812 - FDA Regulatory Timeline and Events

CT1812 is a drug developed by Cognition Therapeutics for the following indication: Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex. 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.

CT1812 (DLB) - FDA Regulatory Timeline and Events

CT1812 (DLB) is a drug developed by Cognition Therapeutics for the following indication: Dementia with Lewy bodies (DLB). 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.

Cognition 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, Cognition Therapeutics (CGTX) has reported FDA regulatory activity for the following drugs: CT1812 and CT1812 (DLB).

The most recent FDA-related event for Cognition Therapeutics occurred on July 10, 2025, involving CT1812. The update was categorized as "FDA Meeting," with the company reporting: "Cognition Therapeutics, Inc., announced that it conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025."

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

  • Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex. - CT1812
  • Dementia with Lewy bodies (DLB) - CT1812 (DLB)

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